Senior Validation Engineer

Direct message the job poster from PCI Pharma Services

Are you a passionate validation engineer looking to make an impact in the medical device industry? We are on the hunt for a talented Senior Validation Engineer to drive our validation efforts in our dynamic Contract Development and Manufacturing Organization (CDMO). In this pivotal role, you’ll lead the charge on equipment, process, and cleaning validations, ensuring we meet the highest standards of FDA, ISO 13485, and other regulatory requirements.

Your expertise will be crucial in supporting new product introductions, facilitating technology transfers, and sustaining seamless operations for both clinical and commercial manufacturing. If you thrive in a fast‑paced environment and are committed to excellence in validation, we want to hear from you!

• Lead and execute validation lifecycle activities, including IQ/OQ/PQ for manufacturing equipment, utilities, and automated assembly lines.
• Develop and execute validation master plans, protocols, and reports in compliance with internal procedures and regulatory expectations.
• Provide validation support for process changes, new product introductions (NPIs), and customer tech transfers.
• Apply risk‑based approaches (e.g., per ISO 14971) to validation strategy and justification.
• Utilize statistical methods to define sampling plans and acceptance criteria for validation studies.
• Support cleaning validation and verification activities for equipment used in medical device production.
• Collaborate with cross‑functional teams, including Manufacturing, Quality, Engineering, and Regulatory Affairs.
• Review and approve equipment specifications, process FMEAs, URS, and validation documentation.
• Conduct gap assessments and remediation planning for existing validation documentation when required.
• Ensure all validation activities meet the standards set by FDA 21 CFR Part 820, ISO 13485, and customer requirements.
• Support regulatory and customer audits as the validation SME.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
• Minimum of 5–8 years of validation experience in the medical device, pharmaceutical, or biotech industry.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and GAMP 5 principles.
• Hands‑on experience with equipment and process validation on assembly lines (manual, semi‑automated, or fully automated).
• Proficient in risk management and statistical tools (e.g., Minitab, JMP).
• Excellent technical writing and communication skills.
• Ability to manage multiple projects and timelines in a dynamic manufacturing environment.

• Experience with vision systems, leak testers, ultrasonic welding, and other medical device assembly technologies.
• Familiarity with software validation and PLC‑based control systems.
• Six Sigma certification or formal training in statistical process control (SPC).

Base salary hiring range is $97,280‑$107,008, plus a 5 % MBP annual performance bonus eligibility. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full‑time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

Mid‑Senior level

Full‑time

• Pharmaceutical Manufacturing and Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)
• Tuition assistance
• Paid paternity leave
• Paid maternity leave
• Disability insurance