CQV Specialist – Life Sciences (Hybrid)

The Epsten Group; Columbus (OH); Hybrid; USD 90,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off and company holidays

Wellness programs and employee assis t

Job summary

Salas O’Brien in Columbus, OH seeks a CQV Specialist to lead commissioning and qualification activities for FDA-regulated projects. The role focuses on IQ/OQ/PQ, risk assessments, and interface with OEMs and construction teams.

You will develop CQV Master Plans, write summaries, and defend results to clients and regulators. A BS/BA in a scientific/engineering field with relevant experience is required.

Qualifications

• Bachelor’s degree in scientific/technical/engineering with 5–7 years in FDA-regulated env.
• Associate degree with 7–10 years in FDA or regulated env.
• Proficiency in Windows & MS Office (Word & Excel).
• Knowledge of FDA regulations / cGMPs and GAMP.

Responsibilities

• Conduct cGMP Audits, Gap Analysis, and Risk/Impact Assessments.
• Develop system specifications per GAMP and GEP.
• Develop CQV Master Plans describing scope, intent and strategy.
• Interface with OEMs, CM and contractors to develop commissioning/test protocols.
• Interface with end users to develop validation protocols (IQ/OQ/PQ).
• Develop Trace Matrices linking UR/FS/DS to verifications.
• Develop Summary Reports summarizing CQV efforts.
• Represent validation results to client auditors and regulatory authorities.
• Lead validation specialists and manage project tasks.

Skills

FDA regulations

cGMPs

GAMP

Education

Bachelor’s degree in a scientific/technical/engineering discipline

Associate degree in same disciplines or skilled technician/military veteran

Tools

Windows & Microsoft Office (Word & Excel)

Job description

Salas O’Brien in Columbus, OH seeks a CQV Specialist to lead commissioning and qualification activities for FDA-regulated projects. The role focuses on IQ/OQ/PQ, risk assessments, and interface with OEMs and construction teams.

You will develop CQV Master Plans, write summaries, and defend results to clients and regulators. A BS/BA in a scientific/engineering field with relevant experience is required.