QC Validation Engineer
GSK
August 19, 2026
On-site
Marietta, PA
Operations
Position Summary:
- Support validation activities in QC, including new equipment qualification and existing equipment requalification.
- Manage non-testing systems/processes for QC, including vendor management and on-site calibration training for QC equipment.
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in alignment with corporate standards.
Responsibilities:
- Support the Validation Life Cycle in QC (design through operation/improvement and decommissioning).
- Develop validation approaches for new equipment; qualify QC equipment and maintain validated state.
- Author and execute IQ/OQ/PQ protocols and reports; prepare related validation documentation (e.g., URS, validation master plans, risk assessments, reviews).
- Perform PM/calibration/requalification for QC equipment (e.g., temperature/humidity chambers, balances) and update related procedures.
- Maintain validation knowledge; instruct site personnel; represent QC input on VMP/FMP when appropriate.
- Represent QC validation during audits; respond to regulatory questions.
- Lead installation, qualification, validation, and lifecycle management for analytical instruments and laboratory computer systems; manage calibration/maintenance/documentation.
- Support validation of computerized systems, access controls, and data integrity; lead investigations, change controls, and corrective actions.
- Prepare/maintain procedures/specifications/validation documentation; train lab staff.
- Perform all responsibilities in compliance with EHS and GMP regulations and SOPs.
Basic Qualifications (Required):
- Bachelor’s degree in chemistry/biology/engineering or related field (or 5+ years’ experience in lieu of preferred degrees).
- 2+ years in a cGMP-regulated laboratory environment.
- 2+ years of pharmaceutical validation experience for equipment/systems, including IQ/OQ/PQ documentation.
- Hands-on experience with equipment lifecycle (installation, IQ/OQ/PQ, calibration, maintenance) and computerized lab systems.
- Experience writing/executing IQ/OQ/PQ; strong knowledge of GMP, NIH Guidelines, FDA, and other regulatory requirements.
- Commitment to accuracy/quality; strong written/verbal communication; collaborative.
Preferred Qualifications:
- Experience with inspections/audits; familiarity with LIMS/LES and instrument software; data integrity standards.
- Experience with laboratory automation/digital solutions; leading readiness or improvement initiatives; strong technical writing.
- Ability to follow procedures, document results per GxP, and maintain attention to detail across tasks.
How to apply:
- Submit your resume and a short note describing a validation, investigation, or readiness project you led (challenge, approach, outcome).
- Support validation activities in QC, including new equipment qualification and existing equipment requalification.
- Manage non-testing systems/processes for QC, including vendor management and on-site calibration training for QC equipment.
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in alignment with corporate standards.
Responsibilities:
- Support the Validation Life Cycle in QC (design through operation/improvement and decommissioning).
- Develop validation approaches for new equipment; qualify QC equipment and maintain validated state.
- Author and execute IQ/OQ/PQ protocols and reports; prepare related validation documentation (e.g., URS, validation master plans, risk assessments, reviews).
- Perform PM/calibration/requalification for QC equipment (e.g., temperature/humidity chambers, balances) and update related procedures.
- Maintain validation knowledge; instruct site personnel; represent QC input on VMP/FMP when appropriate.
- Represent QC validation during audits; respond to regulatory questions.
- Lead installation, qualification, validation, and lifecycle management for analytical instruments and laboratory computer systems; manage calibration/maintenance/documentation.
- Support validation of computerized systems, access controls, and data integrity; lead investigations, change controls, and corrective actions.
- Prepare/maintain procedures/specifications/validation documentation; train lab staff.
- Perform all responsibilities in compliance with EHS and GMP regulations and SOPs.
Basic Qualifications (Required):
- Bachelor’s degree in chemistry/biology/engineering or related field (or 5+ years’ experience in lieu of preferred degrees).
- 2+ years in a cGMP-regulated laboratory environment.
- 2+ years of pharmaceutical validation experience for equipment/systems, including IQ/OQ/PQ documentation.
- Hands-on experience with equipment lifecycle (installation, IQ/OQ/PQ, calibration, maintenance) and computerized lab systems.
- Experience writing/executing IQ/OQ/PQ; strong knowledge of GMP, NIH Guidelines, FDA, and other regulatory requirements.
- Commitment to accuracy/quality; strong written/verbal communication; collaborative.
Preferred Qualifications:
- Experience with inspections/audits; familiarity with LIMS/LES and instrument software; data integrity standards.
- Experience with laboratory automation/digital solutions; leading readiness or improvement initiatives; strong technical writing.
- Ability to follow procedures, document results per GxP, and maintain attention to detail across tasks.
How to apply:
- Submit your resume and a short note describing a validation, investigation, or readiness project you led (challenge, approach, outcome).