CQV Specialist – Upstream Process Equipment & Downstream Biotech Process Equipment

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry.

As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.

With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets : United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.  Key Responsibilities : Develop, review, and execute qualification and validation protocols (IQ, OQ, PQ) for upstream and downstream process equipment.

Participate in equipment installation, start-up, and commissioning projects.

Review and approve technical documentation related to equipment, including manuals, procedures, and validation reports.

Collaborate with cross-functional teams including Engineering, Operations, and QA / QC to ensure regulatory compliance.

Identify risks and opportunities for process and equipment improvement.

Provide support during internal and external audits related to CQV activities.

Maintain accurate and up-to-date CQV records and documentation in accordance with industry standards.

Qualifications / Requirements : Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or related field.

Minimum 3–5 years of experience in commissioning, qualification, and validation of biotech process equipment (both upstream and downstream).

Strong knowledge of GMP, FDA, cGMP, and international regulatory requirements.

Hands-on experience developing and executing IQ, OQ, and PQ protocols.

Excellent teamwork, communication, and problem-solving skills.

Proficiency in technical documentation software and validation tools (e.g., AutoCAD, TrackWise, Veeva).

Preferred Skills : CQV, Process Validation, or Project Management certifications.

Experience with fermentation, chromatography, filtration, or downstream process systems.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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