CQV Specialist: Validation & Commissioning Expert

Salas O'Brien, Inc.; 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

Job summary

Salas O’Brien is seeking a CQV Specialist to lead commissioning and validation activities in Columbus, OH. You will develop CQV Master Plans, conduct cGMP audits, and interface with OEMs, CMs, and contractors to execute CQV protocols.

The role requires a Bachelor’s in engineering or science and 5–7 years of FDA-regulated experience. You’ll guide a team, manage multiple projects, and ensure compliance with GAMP, FDA cGMPs, and Good Engineering Practices.

Qualifications

• Bachelor’s degree in engineering, science, or related field with FDA experience.
• Experience in CQV or commissioning in regulated environments.
• Knowledge of cGMPs and GAMP guidelines.

Responsibilities

• Conduct cGMP Audits, Gap Analysis, and Risk/Impact Assessments as required to scope CQV efforts.
• Develop system specifications per GAMP and Good Engineering Practices (GEP).
• Develop project CQV Master Plans (CQVP) describing CQV scope and strategy.
• Interface with OEM, CM, and contractors to execute commissioning protocols and checklists.
• Interface with end users to develop validation protocols (IQ/OQ/PQ) and analyze data.
• Develop Trace Matrices linking UR/FS/DS to field verifications.
• Prepare Summary Reports summarizing CQV efforts and defend results to auditors.

Skills

Project management

Analytical thinking

Team leadership

Communication

Regulatory knowledge

Education

Bachelor’s degree in engineering/science

5-7 years FDA-regulated experience

Tools

Windows & MS Office

Field measuring instrumentation

GAMP knowledge

Job description

Salas O’Brien is seeking a CQV Specialist to lead commissioning and validation activities in Columbus, OH. You will develop CQV Master Plans, conduct cGMP audits, and interface with OEMs, CMs, and contractors to execute CQV protocols.

The role requires a Bachelor’s in engineering or science and 5–7 years of FDA-regulated experience. You’ll guide a team, manage multiple projects, and ensure compliance with GAMP, FDA cGMPs, and Good Engineering Practices.