Job Description

Job Description

Job Title: Senior Validation Engineer – Medical Device Assembly (CDMO)

Location: [Rockford]

Department: Quality

Reports To: Director of Quality

Position Summary:

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 efforts in equipment, process, and cleaning validation 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.

Key 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.

Qualifications:

• 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.

Preferred Qualifications:

• 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).

For candidates in Illinois: This position's 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.

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