Overview
Supporting the technical services team, the Senior Associate is 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.
The role manages and coordinates the schedules of calibration technicians, tracks all maintenance and calibration activities through the Computerized Maintenance Management System (CMMS) Maximo, and authorises validation lifecycle documents for computer-related systems including data integrity testing and business administration.
Key Responsibilities
Select and procure laboratory equipment in accordance with Amgen requirements.
Own and project-manage change controls, adhering to change control metrics.
Plan, execute and document the qualification of new laboratory equipment in a cGxP regulated environment.
Develop and maintain equipment qualification project plans, requirements, qualification protocols and summary reports as part of the commissioning process.
Generate and resolve protocol deviations as required.
Write or contribute to equipment operating procedures and manuals.
Design and conduct training for QC staff and other department staff as applicable.
Develop and maintain Data Integrity Assessments for QC laboratory systems.
Conduct periodic reviews of instrument validation as part of the validation lifecycle.
Manage laboratory equipment replacement through lifecycle management programmes.
Support safety-related investigations relating to laboratory equipment.
Develop and own maintenance and calibration programmes for QC laboratory equipment.
Assess and review pharmacopeia updates for impacts to maintenance programmes.
Plan and conduct routine calibration, re-qualification and maintenance of laboratory equipment, ensuring schedules are adhered to as per CMMS Maximo.
Coordinate equipment repairs and maintenance with vendors/contractors and perform maintenance to minimise downtime.
Lead programmes to improve equipment performance and reliability.
Alert Quality Control Management when equipment fails to meet calibration or qualification requirements and conduct impact assessments and investigations.
Serve as point of contact with laboratory equipment vendors and engineers.
Review and file QC calibration and maintenance documentation.
Coordinate the audit of new vendors with Amgen Global.
Support deviations and investigations relating to equipment.
Defend Amgen's laboratory systems validation, maintenance and data integrity philosophy in audit situations.
Contribute to a culture of continuous improvement and participate in technical project teams as a subject-matter expert on instrument validation regulations and procedures, support global/enterprise system lifecycle management, laboratory investigations and deviations.
Carry out any other tasks or projects assigned as per the manager's request.
Qualifications
Bachelor's degree in a science-related field is required.
Minimum of 5+ years of laboratory experience in a cGXP laboratory environment, including exposure to analytical instrument validation.
Detailed knowledge of the methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
Understanding of current regulatory requirements for cGXP laboratory equipment validation and electronic record integrity.
Demonstrated success in managing an equipment qualification or maintenance program (advantageous).
Key Amgen Values
Ensure Quality, Team Work, Be Science Based, Collaborate, Communicate, Be Accountable.
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