Validation Engineer; APS

Sr. Technical Recruiter | Life Sciences, Biopharma & IT Hiring Expert | 12+ Yrs in Talent Acquisition | Boolean Search Pro | Pharma, Healthcare…

• Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review.
• Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards.
• Perform equipment and analytical instrument qualification following regulatory and internal guidelines.
• Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements.
• Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks.
• Support validation of automated manufacturing systems and sterile process controls.
• Maintain accurate, audit-ready validation documentation in compliance with quality system requirements.
• Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek.
• Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP).

Seniority Level: Mid-Senior level

Employment Type:

Contract

Job Function:
Information Technology, Telecommunications

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