Validation Engineer II (Biopharma)

Location: Boulder, Colorado, United States

Salary: $84,000–$105,000 per year

Company

hirify.global is a contract development and manufacturing organization providing drug development and biologics manufacturing services to life science companies across locations in the USA and Europe.

What you will do

• Facilitate the validation lifecycle for cGMP biopharmaceutical manufacturing operations.
• Support facilities, utilities, equipment, computer system, process control system, cleaning, steaming, air visualization, and mixing validations.
• Draft, execute, review, and approve validation documentation, deviations, CAPAs, and change controls.
• Coordinate validation testing, risk and impact assessments, engineering specification reviews, and audit or inspection readiness activities.
• Provide technical input on validation strategies and change control requirements.
• Support or lead business and operational excellence projects and departmental initiatives.

Requirements

• Bachelor’s degree in a scientific or biochemical engineering discipline with 5+ years of experience supporting manufacturing in a fermentation or cell culture environment, or a master’s degree.
• Knowledge of quality systems and cGMP requirements across FDA, EU, and ICH regulatory frameworks.
• Ability to interpret technical documents, engineering specifications, P&IDs, operating procedures, and production records in English.
• Strong risk assessment, critical thinking, problem-solving, time management, and multitasking skills.
• Experience with MS Office, electronic document and information management systems, engineering software tools, and Excel data analysis.
• Ability to work independently, collaborate across quality and engineering disciplines, and coordinate with external contractors.

Nice to have

• Risk management and project management skills.
• Experience with control system software and statistical software.

Culture & Benefits

• Full-time employment in a biopharmaceutical development and manufacturing environment.
• Annual bonus structure.
• Medical, dental, and vision coverage.
• Paid paid time off and holidays.
• 401(k) matching with 100% vesting after 60 days.