Sr. Validation Engineer

PCI Pharma Services • Rockford, IL

7d • $97,280 - $107,008

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are seeking a highly skilled Senior Validation Engineer to support the validation activities associated with medical device assembly lines within a fast-paced Contract Development and Manufacturing Organization (CDMO). The ideal candidate will lead equipment, process, and cleaning validation efforts to ensure compliance with FDA, ISO 13485, and other applicable regulatory standards. This role is critical in supporting new product introductions, technology transfers, and sustaining operations for both clinical and commercial manufacturing.

Requirements

• 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.

Nice To Haves

• 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).

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level