MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects - Validation & Engineering Group : Job Details

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Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries, including Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Scientist to qualify equipment within a Quality Assurance (QA) Laboratory. The ideal candidate will have a strong background in CQV, ensuring compliance with Good Manufacturing Practices (GMP), and delivering projects on time and within budget.

• Qualify laboratory equipment and systems in compliance with GMP standards.
• Develop and execute Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports.
• Participate in risk assessments, Data Integrity, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT).
• Ensure laboratory automation systems are validated and compliant.

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of project management experience in a GMP-regulated laboratory environment.
• Proven experience with laboratory automation systems and CQV processes.
• Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
• Proficiency in MS Windows and Microsoft Office applications.
• Technical writing skills and experience with investigations processes.
• Availability to work extended hours, including weekends and holidays.

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Strategy/Planning and Information Technology

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