Amgen Sr. Associate Technical Engineer in Juncos, Puerto Rico

SUMMARY

The Sr. Associate Technical Engineering role will support Inspection and Packaging and AML 23 Solid Dosage Operations and will provide technical engineering support on all equipment automation/visual technology optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards in NON STANDARD SHIFT.

SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Troubleshoot, repair and/or restore manufacturing equipment automation and or Process Control Systems in compliance with all applicable industry standards, regulatory standards and FDA standards.

  • Support the line owners, system owners and project teams in the implementation of changes in automation code and/or systems as part of change controls, CAPAs, work orders, etc.

  • Provide technical assessments automation related NCs, change controls, validations and other type of investigations.

  • Support the startup and validation of new systems and/or equipment automation systems.

  • Review technical specification documents to ensure their inclusion of automation requirements/specifications per AML standards.

  • Complete technical and safety trainings per requirements of the job and organization as specified in training module.

  • Support Operations in Non Standard shifts that includes weekends and/or holydays as determined by busyness.

  • Assist the manufacturing plant during FDA and other regulatory agency inspections providing technical support and or assessments in response to the FDA and other regulatory agencies.

BASIC EDUCATON & EXPERIENCE

Bachelors Degree and 2 years of Automation experience in Pharmaceutical, Medical Device or Biotechnology Industry.

PREFERRED QUALIFICATIONS

  • Educational background in Electrical, Mechanical, Computer Engineering or Electronic Engineering Technology

  • Working knowledge in automation system (e.g. vision system, sensors, data acquisition, PLC, robotic, lasers)

  • Working knowledge of equipment mechanical process (e.g. servomotors, pneumatics)

  • Experience in the support of Validation activities

  • Documentation under GMP environment

  • Work experience in Pharmaceutical manufacturing automation systems maintenance Experience with Rockwell Automation systems ( ControLogix, RSView, RSBatch ) preferred.

  • Troubleshooting experience with Automation systems is desired

  • Effective communication (verbal and written) at all levels

  • Presentations skills

  • Escalate issues professionally and on a timely basis

  • Knowledge of statistical analysis tools

  • Technical writing for investigation

  • Negotiation skills

  • Project Management and organizational skills, including ability to follow assignments through to completion

  • Knowledge of validation processes and understanding of validation protocol execution requirements

  • Knowledge of Reliability Maintenance and Process Optimization

  • Problem Solving and troubleshooting

  • Knowledge in continuous improvement tools and methodologies

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.