Commissioning / Qualification / Validation Specialist (FDA-Regulated)

TL;DR

Commissioning / Qualification / Validation Specialist (FDA-Regulated): Developing and executing CQV protocols for pharmaceutical, biotech, food, and cosmetics facilities with an accent on cGMP compliance, GAMP-based specifications, and IQ/OQ/PQ validation. Focus on analyzing regulated systems, building traceability and validation documentation, leading specialists, and defending results before client auditors and regulatory authorities.

Location: Columbus, Ohio, USA; hybrid work arrangement with up to 25% travel

Salary: $90,000–$100,000 annually, plus performance-based bonuses

Company

Salas O’Brien is an employee-owned engineering and professional services firm providing integrated engineering, consulting, commissioning, and validation services across life sciences, infrastructure, buildings, and advanced technology.

What you will do

• Conduct cGMP audits, gap analyses, and risk or impact assessments to define CQV scope.
• Develop system specifications, CQV Master Plans, traceability matrices, and summary reports.
• Coordinate with equipment manufacturers, construction managers, contractors, and end users to execute commissioning and validation protocols.
• Execute IQ/OQ/PQ activities, compile qualification data, and verify facilities, equipment, control systems, utilities, and HVAC conditions.
• Represent validation results before client auditors and regulatory authorities.
• Lead validation specialists and manage multiple projects, schedules, costs, and customer communications.

Requirements

• Bachelor’s degree in a scientific, technical, or engineering discipline with 5–7 years of experience in an FDA-regulated environment, or an associate degree, skilled technician, or military background with 7–10 years of regulated-environment experience.
• Considerable knowledge of FDA regulations, cGMPs, and GAMP.
• Ability to evaluate engineering specifications, wiring diagrams, P&IDs, HVAC and mechanical drawings, and architectural layouts.
• Experience configuring and operating field measuring instrumentation.
• Ability to work independently, lead teams, manage scope and change, and solve project problems.
• Excellent written, verbal, and presentation skills; proficiency with Windows, Microsoft Word, and Excel.

Culture & Benefits

• Employee-owned organization with a people-first approach and focus on sustainable, long-term solutions.
• U.S.-based medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and company holidays.
• Wellness programs, employee assistance resources, and professional development support.