PCI Pharma Services · 14 hours ago
Sr. Validation Engineer
Rockford, IL
Full-time
Onsite
Mid, Senior Level
$97K/yr - $107K/yr
5+ years expPCI Pharma Services is a company dedicated to life-changing therapies with a global impact. They are seeking a highly skilled Senior Validation Engineer to support validation activities for medical device assembly lines, ensuring compliance with regulatory standards and supporting new product introductions and technology transfers.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Hiring Manager
Shaniece Williams
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
Qualification
Required
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
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)
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase