Senior Validation Engineer Job at PCI Pharma Services (Rockford)

Senior Validation Engineer

PCI Pharma Services

Location:
United States , Rockford

Category:
Manufacturing

Contract Type:
Not provided

Salary:

97280.00 - 107008.00 USD / Year

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Job Description:

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.

Job Responsibility:

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

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 have:

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)

What we offer:

5% MBP annual performance bonus eligibility
paid time off
health insurance coverage (including dental and vision)
flexible spending account
401(k)

Additional Information:

Job Posted:
February 20, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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