<?xml version="1.0" encoding="utf-8"?>
<source><publisher>Amgen Jobs</publisher><publisherurl>http://www.amgen.jobs</publisherurl><lastBuildDate>2012-05-26 16:28:32.412341</lastBuildDate><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 13504BR
Job Posting Title Sr Mgr Manufacturing - Vial Fill
Career Category Manufacturing
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Sr. Manager Manufacturing - Vial Fill

Amgen Dun Laoghaire - Dublin

Overview:

This position will report to the Director of Manufacturing. The ideal candidate will provide strong management and leadership in the Manufacturing – vial fill facility.

Key Responsibilities:

• Manage the Vial Fill Manufacturing Facility department.
• Lead in the development of long range planning (LRP) to maintain the highest level of productivity.
• Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.
• Develop, maintain, and justify the departments’ budgets.
• Responsible for ensuring that all manufacturing is carried out under GMP conditions and in a safe working environment.
• Support the plant in the project approval, prioritization, and implementation process.
• Develop metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data.
• Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department.
• Assure the appropriate level of training is undertaken for all levels of the manufacturing syringe organization which may involve developing training material.
• Responsible for attaining and improving site based metrics targets.
• Responsible for recruiting talented staff into the facility and setting standards for their performance.
• This position will need to complete some travel to the other Amgen sites over the next two years.

* Other functions may be assigned.
Basic Qualifications Basic Qualifications

• Typically 8+ years of experience in facilities management position. With typically 4+ years experience supervising technical staff
• Bachelor’s Degree or combination of education and/or years of experience.
Preferred Qualifications Preferred Qualifications

• Knowledge of conflict resolution
• Ability to partner with other departments.
• Analytical problem solving.
• Considerable Organization skills.
• Experience in coaching, mentoring and counselling.
• Ability to deal with and manage change.
• Ability to set goals.
• Knowledge of applicable regulatory guidelines
• Ability to use company compensation system including mentoring lower management levels when required.
• Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.</description><date_new>2012-03-28 21:28:53</date_new><country>Ireland</country><company>Amgen</company><title>Sr Mgr Manufacturing - Vial Fill</title><state>None</state><reqid>13504BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>27464075</uid><url>http://www.amgen.jobs/xml/27464075/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14509BR
Job Posting Title Engineer - Packaging
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Packaging Engineer

Amgen Job Description Packaging Engineer - Process Development

This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components, the associated systems such as documentation, equipment and processes.

Knowledge of primary and secondary packaging systems and processes, packaging equipment, components and packaging processes, material science and quality system is essential to the position.
The position will leverage organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.

This position is responsible and accountable for the following:

1) Evaluation, recommendation and selection of primary and secondary packaging materials, equipment , and vendors
2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials / equipment.
3) Write Technical Specifications, SOP’s and Bill of Materials
4) Representing Process Development in Drug Product and Global Operation Teams as required
5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes
6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes
7) Ensures cGMP and regulatory compliance are met at all times
8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes
9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems in a timely manner.
11) Excellent problem solving and RCA skills. Excellent report writing skills.
12) Support the NPI process
13) Effectively review and close out non conformances by CAPA
14) Participate in FAT, SAT

Demonstrated Competencies/Skills:
1) Independent thinker with demonstrated skills working in teams or leading project teams
2) Strong Interpersonal and communication skills
3) Ability to multi-task and manage tight timelines
4) Excellent report writing skills
5) Proven problem solving skills and indepth knowledge of problem solving methodologies
6) Knowledge of Regulatory environment
7) Flexible and adaptive – this position will involve travel and shift work.
Basic Qualifications Basic Qualifications • Degree / diploma in engineering discipline with 5 + years relevant pharmaceutical packaging experience
Or
• Degree / diploma in packaging technology / materials sciences with 5 + years relevant pharmaceutical packaging experience</description><date_new>2012-03-22 18:49:02</date_new><country>Ireland</country><company>Amgen</company><title>Engineer - Packaging</title><state>None</state><reqid>14509BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>27320620</uid><url>http://www.amgen.jobs/xml/27320620/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14039BR
Job Posting Title 2 x Manager Manufacturing - Syringe Filling &amp; Inspection
Career Category Manufacturing
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Manager Manufacturing –Syringe Filing &amp; Inspection

Amgen Dun Laoghaire - Dublin

Overview:

The Manager Manufacturing – Syringe Filling &amp; inspection reports to the Sr Manager Manufacturing – Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.

Responsibilities include:

• Responsible for filling and inspection line output during their shift.
• Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment.
• Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.
• Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment.
• Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.
• Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.
• Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Prepared to work on a shift basis, leading a manufacturing team.
• Able to travel to other sites within the organization for certain time periods.
Basic Qualifications Basic Qualifications:
• Bachelors degree in Engineering or Science


Relevant Experience
• Typically 5 – 8 years experience in an aseptic pharmaceutical environment.</description><date_new>2012-03-07 02:05:41</date_new><country>Ireland</country><company>Amgen</company><title>2 x Manager Manufacturing - Syringe Filling &amp; Inspection</title><state>None</state><reqid>14039BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971935</uid><url>http://www.amgen.jobs/xml/26971935/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14042BR
Job Posting Title Sr Engineer - Packaging (Line Owner)
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Sr. Engineer – Packaging
(Line Owner)
Level 5
Amgen Dun Laoghaire - Dublin

Overview:

This position will be part of the packaging group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Sr. Manager Manufacturing –Packaging. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to packaging equipment and associated automation systems.
Responsibilities include:

The chosen candidate would typically be involved in activities such as (but not exclusively);

• Monitoring of day to day manufacturing operations.
• Data trend analysis for all performance aspects of a packaging line.
• The definition and scoping of all process improvement activities relating to the area.
• Solving or escalating problems as appropriate.
• All design reviews associated with equipment purchases.
• Troubleshooting performance trends.
• Risk assessments and mitigation projects relating to line performance.
• Support of new product introductions and supporting introduction of new equipment.
• The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.
• Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.
• Continuous improvement programs and all performance improvement projects.
• Review and approval of changes to operating procedures and the change control process relating to the line.
• Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.
• Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.
• Supporting non conformance investigation.
Basic Qualifications Basic Qualifications:

• Bachelors degree in Engineering (Mechanical, Electrical or Chemical)
• Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
• Significant relevant industrial project experience
Preferred Qualifications Preferred Experience
• Typically 8+ years engineering experience in an aseptic pharmaceutical environment
• Significant experience large project related activities including GMP qualification experience.</description><date_new>2012-03-07 02:05:14</date_new><country>Ireland</country><company>Amgen</company><title>Sr Engineer - Packaging (Line Owner)</title><state>None</state><reqid>14042BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971791</uid><url>http://www.amgen.jobs/xml/26971791/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14037BR
Job Posting Title 4 x Manager Manufacturing - Packaging
Career Category Manufacturing
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Manager Manufacturing – Packaging

Amgen Dun Laoghaire - Dublin

Overview:

The Manager Manufacturing – Packing reports to the Sr Manager Manufacturing – Packaging and will be responsible for the manufacturing teams within the syringe packaging facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.

Responsibilities include:

• Responsible for filling and inspection packaging line output during their shift.
• Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment.
• Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.
• Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment.
• Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.
• Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.
• Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Prepared to work on a shift basis, leading a manufacturing team.
• Able to travel to other sites within the organization for certain time periods.
Basic Qualifications Basic Qualifications:
• Bachelors degree in Engineering or Science


Relevant Experience
• Typically 5 – 8 years experience in an aseptic pharmaceutical environment.
• Previous experience working on packaging lines in a man management role is a distinct advantage.</description><date_new>2012-03-07 02:05:13</date_new><country>Ireland</country><company>Amgen</company><title>4 x Manager Manufacturing - Packaging</title><state>None</state><reqid>14037BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971785</uid><url>http://www.amgen.jobs/xml/26971785/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14038BR
Job Posting Title Senior Engineer - Industrial
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Sr. Engineer – Industrial

Amgen Dun Laoghaire - Dublin

Overview:

This position will be part of the packaging and syringe groups and be responsible identifying and remediating gaps between emerging business requirements and current capabilities within the filling and packaging operations. The Sr. Engineer reports to the Sr. Manager Manufacturing – Syringe.

Responsibilities include:
The chosen candidate would typically be involved in activities such as (but not exclusively);

• Performing resource assessments for each area and developing resource standards and labour models
• Data trend analysis for all performance aspects of the area.
• The definition and scoping of all process improvement activities relating to the area.
• Solving or escalating problems as appropriate.
• Leading improvement initiatives in areas of waste reduction, right first time approaches and productivity improvement.
• Troubleshooting performance trends.
• Risk assessments and mitigation projects relating to line performance.
• Performing resource gap analysis for machinery and labour and developing strategies to close these gaps.
• Continuous improvement programs and all performance improvement projects.
• Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams.
• Review and approval of changes to operating procedures and the change control process relating to the line.
• Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.
Basic Qualifications Basic Qualifications:

• Bachelors degree in Engineering (Mechanical, Electrical or Chemical)
• Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
• Significant relevant industrial project experience
Preferred Qualifications Preferred Experience
• Typically 8+ years engineering experience in an aseptic pharmaceutical environment
• Qualification in Lean and 6-sigma methodologies would be an advantage.
• Significant experience large project related activities including GMP qualification experience.</description><date_new>2012-03-07 02:05:06</date_new><country>Ireland</country><company>Amgen</company><title>Senior Engineer - Industrial</title><state>None</state><reqid>14038BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971749</uid><url>http://www.amgen.jobs/xml/26971749/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14211BR
Job Posting Title 2 x Sr Associate Tech Engineering - Syringe
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Sr. Associate Tech Engineer - Syringe

Amgen Dun Laoghaire - Dublin

Overview:

The Sr. Associate Tech Engineer operates as part of a process team. This position will initially be part of the team responsible for the commissioning, qualification and start up of Amgen’s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility.

Key Responsibilities:

During start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to:
• Participation in equipment design reviews.
• Development and execution of FAT, SAT, IOQ protocols.
• Development, revision and review of technical documents such as SOP’s, job plans etc.
• A willingness to spend time abroad over the next 2 years.
• Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures.

During routine manufacturing operations, the individual will provide technical support to the syringe line by:
• Ensuring that daily output and compliance requirements are met.
• Tracking equipment and process performance to ensure compliance with operating standards.
• Implementing corrective actions when deviations from standard are detected.
• Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required.
• Working to investigate, resolve and closeout all issues relating to NC’s, CAPA’s, process deviations.
• Owning manufacturing area SOP’s and change control reports.
Basic Qualifications Basic Qualifications:

• Degree in Engineering/Science or equivalent
• Significant relevant process engineering industry experience

Key competencies:

• Analytical thinking
• Focus on quality
• Drive for results
• Initiative
• Planning and prioritisation
• Teamwork and Co-operation
Preferred Qualifications Preferred Qualifications.
• Excellent written and verbal communication skills
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections desirable
• Experience leading cross-functional teams desirable
• Experience working with teams and influencing decisions</description><date_new>2012-03-07 02:04:45</date_new><country>Ireland</country><company>Amgen</company><title>2 x Sr Associate Tech Engineering - Syringe</title><state>None</state><reqid>14211BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971668</uid><url>http://www.amgen.jobs/xml/26971668/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14219BR
Job Posting Title 2 x Manager Manufacturing – Syringe, Component Prep &amp; Formulation
Career Category Manufacturing
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Manager Manufacturing – Syringe, Component Prep &amp; Formulation

Amgen Dun Laoghaire - Dublin

Overview:

The Manager Manufacturing – Syringe, Component Prep &amp; Formulation reports to the Sr Manager Manufacturing – Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.

Responsibilities include:

• Responsible for filling and inspection line output during their shift.
• Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment.
• Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.
• Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment.
• Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.
• Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.
• Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Prepared to work on a shift basis, leading a manufacturing team.
• Able to travel to other sites within the organization for certain time periods.
Basic Qualifications Basic Qualifications:
• Bachelors degree in Engineering or Science

Relevant Experience
• Typically 5 – 8 years experience in an aseptic pharmaceutical environment.
• Previous experience of management of Syringe filling and inspection operations is a distinct advantage.</description><date_new>2012-03-07 02:04:18</date_new><country>Ireland</country><company>Amgen</company><title>2 x Manager Manufacturing – Syringe, Component Prep &amp; Formulation</title><state>None</state><reqid>14219BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971519</uid><url>http://www.amgen.jobs/xml/26971519/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 14217BR
Job Posting Title Engineering Projects Manager - Syringe Fill
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Engineer Project Manager - Syringe Filling

Amgen Dun Laoghaire - Dublin

Overview:

This position will be part of the syringe group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing –Syringe. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes.

Responsibilities include:

The chosen candidate would typically be involved in activities such as (but not exclusively);

• Engineering Project lead for Syringe Filing
• The provision of manufacturing input to all capital projects relating to the area.
• The definition and scoping of all process improvement activities relating to the area.
• All design reviews associated with equipment purchases.
• The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.
• Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.
• Continuous improvement programs
• Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.
• Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.
Basic Qualifications Basic Qualifications:
• Bachelors degree in Engineering (Mechanical, Electrical or Chemical)
• Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
• Significant relevant industrial project experience
Preferred Qualifications Preferred Experience
• Typically 8+ years engineering experience in an aseptic pharmaceutical environment
• Significant experience large project related activities including GMP qualification experience.</description><date_new>2012-03-07 02:04:02</date_new><country>Ireland</country><company>Amgen</company><title>Engineering Projects Manager - Syringe Fill</title><state>None</state><reqid>14217BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26971454</uid><url>http://www.amgen.jobs/xml/26971454/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 13864BR
Job Posting Title HVAC &amp; Utilities Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title HVAC/Utilities Validation Engineer

Job Description HVAC/Utilities Validation Engineer

As a HVAC/Utilities validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.

Major Responsibilities

• Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for HVAC and Utilities for a Sterile Fill Finish Facility.
• Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures, including safety and training.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU &amp; International Standards.
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems.
• Participate as required in project activities.
• Review of Existing Site Systems to ensure compliance.
• Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
• Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
Basic Qualifications Experience/Background
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 4-6 years experience in a similar role.


Education Requirements
• A third level qualification in Science, Engineering or a relevant Quality discipline.</description><date_new>2012-02-13 19:30:14</date_new><country>Ireland</country><company>Amgen</company><title>HVAC &amp; Utilities Validation Engineer</title><state>None</state><reqid>13864BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26495641</uid><url>http://www.amgen.jobs/xml/26495641/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 13863BR
Job Posting Title Sterile Filling &amp; Inspection Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title Sterile Filling and Inspection Validation Engineer

Job Description Sterile Filling and Inspection Validation Engineer

As a Sterile Filling and Inspction validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Sterile Syringe Filling and Inspection for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.

Major Responsibilities

• Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Sterile Syringe Filling, Isolator and Inspection for a Sterile Fill Finish Facility.
• Ensure all aspects of Syringe Filling, Isolator and Inspection Validation adhere to required policies and procedures, including safety and training.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU &amp; International Standards.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems.
• Participate as required in project activities.
• Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
Basic Qualifications Experience/Background

• A third level qualification in Science, Engineering or a relevant Quality discipline.
Syringe Filling and Isolator Technology Experience essential
Automated Inspection Technology Experience an advantage
• Minimum 4-6 years experience in a similar role.


Education Requirements
• A third level qualification in Science, Engineering or a relevant Quality discipline.</description><date_new>2012-02-13 19:30:03</date_new><country>Ireland</country><company>Amgen</company><title>Sterile Filling &amp; Inspection Validation Engineer</title><state>None</state><reqid>13863BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26495637</uid><url>http://www.amgen.jobs/xml/26495637/job</url></job><job><country_short>IRL</country_short><city>Dublin</city><description>Auto req 13867BR
Job Posting Title Sr Packaging Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title Senior Packaging Validation Engineer

Job Description Senior Packaging Validation Engineer

As a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.

Major Responsibilities

• Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.
• Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU &amp; International Standards.
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
• Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
• Participate as required in project activities.
• Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
Basic Qualifications Experience/Background

• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 5-10 years experience in a similar role.
Preferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors</description><date_new>2012-02-13 19:29:10</date_new><country>Ireland</country><company>Amgen</company><title>Sr Packaging Validation Engineer</title><state>None</state><reqid>13867BR</reqid><state_short>None</state_short><location>Dublin, IRL</location><uid>26495601</uid><url>http://www.amgen.jobs/xml/26495601/job</url></job></source>
