QC Instrumentation Specialist

PE Global; Dublin; Hybrid; EUR 65,000 - 80,000; Full time

Job summary

PE Global is recruiting a QC Instrumentation Specialist for a leading multinational pharma client in South Dublin. This hybrid contract role focuses on planning, executing, and documenting qualification, calibration, and routine maintenance of laboratory systems in a cGMP QC environment at Amgen Dun Laoghaire.

You will manage the CMMS Maximo, author validation lifecycle documents, and perform data integrity testing.

Qualifications

• 3+ years of laboratory experience in a cGMP environment.
• Exposure to instrument validation and data integrity assessments.
• Understanding of regulatory requirements for cGMP equipment validation and electronic records.

Responsibilities

• Plan, execute and document calibration, qualification and maintenance of lab equipment per CMMS Maximo.
• Plan, execute and document qualification of new lab equipment in a cGMP environment, including writing validation protocols and reports.
• Conduct periodic reviews of instrument validation as part of the lifecycle.
• Alert QC management if equipment fails calibration/qualification and assess impact.
• Coordinate repairs/maintenance with vendors to minimize downtime.
• Support change controls and data integrity assessments for lab systems.

Skills

Calibration

Validation

Data Integrity

cGMP Knowledge

Education

Bachelor's degree in Science

Tools

Maximo CMMS

Job description

PE Global is currently recruiting for a QC Instrumentation Specialist for a leading multi-national Pharma client based in South Dublin.

This is a hybrid contract position.

Role:

• 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 ensuring that all maintenance & calibration activities carried out by Calibration Technicians 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.
• Responsible for the execution of protocols once approved.
• Candidate should have specific hands-on laboratory equipment lifecycle and validation experience.

Responsibilities:

• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Where applicable, owns and project manages change controls and adherence to Change Control metrics
• Supporting and managing the addition of project components to CMMA Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems

Requirements:

• Bachelor's degree in a Science related field is required.
• Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed 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.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***