Amgen QC Senior Associate -Technical Services in Dublin, Ireland

Overview:

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