MFQualification Scientist - QA Lab - Automation and CQV Projects

MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:
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.

• Qualification Scientist - QA Lab - Automation and CQV Projects

Qualifications:

• 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
• Must be proficient using MS Windows and Microsoft Office applications.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.