Senior Validation Engineer

Base pay range

$97,280.00 / yr - $107,008.00 / yr

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!

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

Preferred Qualifications

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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