Amgen QC Senior Associate -Technical Services in Dublin, Ireland


Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen Dun Laoghaire. Responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.

Key Responsibilities

  • Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.

  • Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.

  • Relocation of existing equipment to new Chemistry laboratory.

  • Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.

  • Writing equipment validation protocols and associated summary reports.

  • Maintaining a current working knowledge with regard to regulatory requirements for equipment qualification and calibration.

  • Generation and resolution of protocol discrepancies as required.

  • Alerting Quality Control Management in the event that equipment fails to meet calibration or qualification requirements, and conducting impact assessments/investigations as required.

  • Participation in technical project teams in order to act as a subject matter expert on instrument validation regulations and procedures.

  • Serving as the point of contact with laboratory equipment vendors and engineers.

  • Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as required.

  • Scheduling of repairs and maintenance in order to minimize level of down-time for lab equipment, and disruption to laboratory activities.

  • Writing/contributing to equipment operating procedures and manuals.

  • Designing and conducting training for QC staff, and other department staff as applicable.

  • Owns and project manages change controls and adhere to Change Control metrics.

  • Preparing and presenting periodic management updates on activities to senior management.

  • Conduct periodic reviews of instrument validation as part of validation life cycle.

  • Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.

  • Reviewing & filing of QC calibration & maintenance documentation.

  • Coordinating the audit of new vendors with Amgen Global.

  • Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.

  • Recognised as System Owner & Business Administrator for QC Equipment.

  • A key contributor to Data Integrity Assessments for Lab systems

  • Capable of defending Amgens Lab systems validation and data integrity philosophy in an Audit situation

  • Any other tasks/projects assigned as per manager's request.

Knowledge and Experience:

  • Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.

  • Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.

  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

  • Demonstrated success in managing an equipment qualification or maintenance program advantageous.

  • Key Amgen Values: Team Work, Be Science Based, Collaborate, Communicate, Be Accountable