Job description

Protocol Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for critical manufacturing and lab equipment.
Risk Assessment: Perform failure mode and effects analysis (FMEA) and data integrity assessments to identify critical process parameters and equipment risks.
Vendor & Asset Coordination: Collaborate with equipment vendors to review design specifications (FAT/SAT), technical manuals, and factory acceptance testing data.
Standards Compliance: Ensure all qualification activities strictly comply with cGMP, FDA, EMA, ISO, and 21 CFR Part 11 guidelines.
Deviation Management: Investigate, document, and resolve technical deviations, non-conformances, or protocol failures during qualification runs.
Calibration & Maintenance Support: Partner with maintenance teams to establish preventative maintenance schedules, calibration limits, and standard operating procedures (SOPs).
Re-qualification Oversight: Plan and execute periodic equipment re-qualifications and manage change control impacts on existing validated equipment.
Cross-Functional Collaboration: Coordinate with Quality Assurance (QA), Validation, Engineering, and Operations teams to ensure smooth equipment handover to production.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

Job description

Protocol Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for critical manufacturing and lab equipment.
Risk Assessment: Perform failure mode and effects analysis (FMEA) and data integrity assessments to identify critical process parameters and equipment risks.
Vendor & Asset Coordination: Collaborate with equipment vendors to review design specifications (FAT/SAT), technical manuals, and factory acceptance testing data.
Standards Compliance: Ensure all qualification activities strictly comply with cGMP, FDA, EMA, ISO, and 21 CFR Part 11 guidelines.
Deviation Management: Investigate, document, and resolve technical deviations, non-conformances, or protocol failures during qualification runs.
Calibration & Maintenance Support: Partner with maintenance teams to establish preventative maintenance schedules, calibration limits, and standard operating procedures (SOPs).
Re-qualification Oversight: Plan and execute periodic equipment re-qualifications and manage change control impacts on existing validated equipment.
Cross-Functional Collaboration: Coordinate with Quality Assurance (QA), Validation, Engineering, and Operations teams to ensure smooth equipment handover to production.