CQV Specialist: Biotech Equipment Validation

MENTOR Technical Group Corporation; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

MENTOR Technical Group Corporation is seeking a CQV Specialist to develop and execute qualification protocols for process equipment. The ideal candidate will have a Bachelor’s degree in a relevant field and 3–5 years of experience in qualification and validation.

Candidates should possess strong knowledge of GMP, FDA regulations, and hands-on experience with validation tools. This position is based in Juncos, Puerto Rico with opportunities for growth in a leading engineering firm.

Qualifications

• Minimum 3–5 years of experience in commissioning, qualification, and validation of biotech process equipment.
• Strong knowledge of GMP, FDA, cGMP, and international regulatory requirements.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.

Responsibilities

• Develop, review, and execute qualification and validation protocols for process equipment.
• Participate in equipment installation, start-up, and commissioning projects.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

GMP

FDA regulations

Problem-solving

Communication

Teamwork

Technical documentation

Education

Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or related field

Tools

AutoCAD

TrackWise

Veeva

Job description

MENTOR Technical Group Corporation is seeking a CQV Specialist to develop and execute qualification protocols for process equipment. The ideal candidate will have a Bachelor’s degree in a relevant field and 3–5 years of experience in qualification and validation.

Candidates should possess strong knowledge of GMP, FDA regulations, and hands-on experience with validation tools. This position is based in Juncos, Puerto Rico with opportunities for growth in a leading engineering firm.