CQV Specialist - GMP & FDA Validation in Life Sciences

Salas O'Brien; Columbus (OH); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid time off

Job summary

Salas O'Brien is a full-service engineering firm seeking a CQV Specialist to lead commissioning and validation activities for life sciences, pharmaceutical, and biotech projects in Columbus, OH. The role focuses on IQ/OQ/PQ protocol development, risk assessment, and regulatory alignment to ensure compliant, high-quality facilities.

The ideal candidate has a strong background in CQV, GAMP, and cGMPs, with the ability to manage multiple projects and interface with OEMs, clients, and internal

Qualifications

• Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of FDA-regulated experience.
• Associate degree with 7 to 10 years of experience in an FDA or other regulated environment.
• Proficiency in Windows & Microsoft Office applications (Word and Excel).
• Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).

Responsibilities

• Conduct cGMP Audits, Gap Analysis, and Risk / Impact Assessments as required to scope CQV efforts.
• Develop system specifications per GAMP and / or Good Engineering Practices (GEP).
• Develop project CQV Master Plans (CQVP) that describe CQV scope, intent, and strategy.
• Interface with Original Equipment Manufacturers (OEM), Construction Managers (CM), and construction contractors to develop and execute commissioning protocols and checklists.
• Interface with the end user to develop and execute validation protocols (IQ/OQ/PQ). Execution includes analyzing qualification / validation data.
• Develop Trace Matrices (TM) to illustrate the relation of system requirements (UR/FS/DS) and verifications (IQ/OQ/PQ).
• Develop Summary Reports (SR) that clearly summarize CQV efforts.
• Represent and defend validation results to client auditors and regulatory authorities.
• Lead validation specialists in the execution of project tasks.
• Perform other related duties as required and/or assigned.

Skills

CQV Expertise

Project Management

Regulatory Compliance

Client Communication

Education

Bachelor’s degree in scientific/engineering discipline

Associate degree with 7–10 years in FDA environment

Tools

Microsoft Office

Field measuring instrumentation

Job description

Salas O'Brien is a full-service engineering firm seeking a CQV Specialist to lead commissioning and validation activities for life sciences, pharmaceutical, and biotech projects in Columbus, OH. The role focuses on IQ/OQ/PQ protocol development, risk assessment, and regulatory alignment to ensure compliant, high-quality facilities.

The ideal candidate has a strong background in CQV, GAMP, and cGMPs, with the ability to manage multiple projects and interface with OEMs, clients, and internal