QC Validation Engineer
QC Validation Engineer
Job Details
Vacancies
1 position
Experience Required
No experience required
Job Description
We are seeking a highly skilled professional with hands-on experience in the qualification, requalification, relocation, decommissioning, and retirement of GMP laboratory equipment. The ideal candidate will have a strong background in Good Manufacturing Practice (GMP) within the pharmaceutical industry and a proven track record of managing both complex and simple laboratory instruments.
This is a 6-month contract role.
Key Responsibilities
- Lead and execute qualification, requalification, relocation, decommissioning, and retirement activities for GMP laboratory equipment.
- Ensure compliance with GMP standards and regulatory requirements throughout equipment lifecycle management.
- Collaborate with cross-functional teams (Quality Assurance, Validation, Engineering, and Laboratory staff) to plan and implement equipment-related projects.
- Maintain accurate documentation and reports for audits and inspections.
- Provide technical support and guidance on equipment handling, calibration, and compliance.
Required Experience
For Senior Role:
Minimum 5 years of experience with complex GMP laboratory equipment, including but not limited to:
UV-Vis Spectrometer, TOC Analyzer, Microplate Reader, Liquid Particle Counter, Capillary Electrophoresis (CE), High-Performance Liquid Chromatography (HPLC), Analytical Balances, Incubators, Particle Counters
For Associate Role:
Minimum 2 years of experience with simpler GMP laboratory equipment, including but not limited to:
- Ovens
- Controlled Temperature Units
- Centrifuges
Qualifications
- Strong knowledge of GMP regulations and pharmaceutical industry standards.
- Experience in equipment lifecycle management within a GMP-regulated environment.
- Excellent documentation and organizational skills.
- Ability to work independently and in cross-functional teams.
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