Commissioning / Qualification / Validation Specialist (Biotech)

Location: Columbus, Ohio, USA; hybrid. Travel up to 25%.

Salary: $90,000–$100,000 per year, plus performance-based bonuses.

Company

Salas O’Brien is an employee-owned engineering and professional services firm providing integrated engineering, consulting, commissioning, and qualification/validation services across multiple industries.

What you will do

• Conduct cGMP audits, gap analyses, and risk/impact assessments to define CQV scope.
• Develop system specifications, CQV master plans, commissioning protocols, checklists, validation protocols, trace matrices, and summary reports.
• Execute IQ/OQ/PQ validation activities and compile and analyze qualification data.
• Coordinate with equipment manufacturers, construction managers, contractors, end users, and clients.
• Represent and defend validation results to client auditors and regulatory authorities.
• Lead validation specialists and manage multiple projects, schedules, progress, costs, and scope changes.

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/relevant technician or military background with 7–10 years of regulated-environment experience.
• Considerable knowledge of FDA regulations, cGMPs, GAMP, and the food, pharmaceutical, or biotech industries.
• Ability to evaluate specifications, wiring diagrams, P&IDs, HVAC/mechanical drawings, and architectural layouts.
• Experience configuring and operating portable field-measuring instrumentation.
• Strong written, verbal, presentation, problem-solving, project-management, and team-leadership skills.
• Proficiency with Windows, Microsoft Word, and Microsoft Excel.

Culture & Benefits

• Employee-owned organization with a people-first approach to problem solving.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and company holidays.
• Wellness programs, employee assistance resources, and professional development support.