Qualification Scientist - QA Lab - Automation and CQV

Job Description

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.

Full-time