Amgen Sr. Associate Manufacturing - MBR Designer in Dublin, Ireland
Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions
Responsible for drafting , executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design
Responsible for the support and ongoing development of the Amgen Dun Laoghaire MES system in development of MBRs and improving the MES business process.
Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff)
Responsible for production support to assist in fast Manufacturing Execution System (MES) issue resolution, including presence in the production suite and also during non-standard shifts
Responsible for liaising with production managers, operators and other relevant personnel as part of the review and update of MBRs and during production as required.
Responsible for the development, review and update of MES Standard Operating Procedures.
Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.
Accountable for adherence to established timelines and metrics for the change control and CAPA process.
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server
Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
Liaison with Amgen MES core-team to troubleshoot and develop new ways of working
Responsible for providing technical support where required and as directed by Operations leadership
Other Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.
Business Execution and Compliance
Responsible for owning and tracking Change controls as required and in a timely manner
Responsible for liaising with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch documentation and processes
Non-Conformance and CAPA
Responsible for owning and tracking Corrective and Preventative Actions (CAPAs) as required
Responsible for Class 1 NCs as required
Support other investigations, Non-Conformance and CAPA Review Boards where required.
Responsible for the implementation of Change Controls related to the Manufacturing facility.
Responsible for contributing to and assisting with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits
Support any internal & external regulatory agencies activities during inspections.
Staff Training and Qualification
Responsible for personal GMP training compliance
Support technical training assignments for staff in Patient Supply.
Continuous improvement & Projects
Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities
Support implementation of process changes
- Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures.
Responsible for development of personal annual reviews, goal setting and Individual Development Plans via the Maximizing Amgen Performance (MAP) process.
Support the MAP process by completing peer to peer feedback
May perform some limited NC Owner duties as required.
Primary knowledge, skills, competencies and relevant experience
Bachelor degree in Science, Engineering, IT or the equivalent combination of experience and education
Typically 3-5 years of MES related experience in highly regulated GMP environments
Working knowledge of solid dosage manufacturing and packaging; parenterals in pharmaceutical/biotech industries or aseptic processing
Knowledge of regulation requirements (including cGMP, 21CFR Part11)
Knowledge of audit handling process
Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA)
Knowledge of validation processes and understanding of validation protocol generation requirements
Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, QMTS, EDMQ)
Practical knowledge in continuous improvement tools and methodologies
MES experience with focus on workflow, S95 & S88 standards & integration from the control layer to ERP via MES
Strong attention to details, including the ability to proofread documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently
Ability to interpret requirements and apply GMP and regulatory Knowledge as related to documentation
Excellent organisational and communication (verbal and written) skills at all levels of the organisation
Strong Technical writing for investigations, procedures and change controls
Reliable, pro-active, motivated and enthusiastic individual
Ability to help others understand and implement complex instructions
Ability to work guided by objectives of the department or assignments
Refers to established policies and precedents as needed
May set project timeframes and priorities based on project objectives and ongoing assignments
Recognizes and escalates problems
Contributes to department/unit by ensuring quality of tasks/services provided by self
Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
Applies knowledge and understanding of internal customer needs
Establishes working relationships with others outside area