PCI Pharma Services · 5 months ago
Computer Systems Validation Engineer III
Bedford, NH, USA
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life changing therapies and global impact. They are seeking a CSV Validation Engineer III to lead validation activities for GxP computer systems, ensuring compliance with regulatory standards and collaborating with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Lead validation activities throughout the computer system lifecycle—including plans, protocols, scripts, and summary reports
Develop test strategies, perform system assessments, and execute validation protocols for GxP systems and infrastructure
Ensure compliance with FDA (21 CFR Part 11, 820), cGMP, and global industry regulations
Collaborate cross-functionally with Manufacturing, QA, IT, and Engineering teams
Execute change controls and revalidation projects across systems such as PCS, BMS, CMS, OSI PI, and automation platforms
Train colleagues and contractors on best practices for computer system implementation and validation
Support periodic reviews and ensure the continued compliance of validated systems post-Go-Live
Qualification
Required
5+ years of hands-on experience in a cGMP-regulated environment, with at least 3 years focused on automation and validation
Strong knowledge of validation for manufacturing equipment, utilities, clean media systems, and facilities
Experience with industry standards like GAMP and regulations including 21 CFR Part 11, 210, 211, 820, and ICH Q7A
A deep understanding of system risk assessments, gap analysis, and remediation plans
Excellent communication and documentation skills—able to write clear, audit-ready validation deliverables
Team-first mindset with the ability to work independently on multiple complex projects
Proficiency in Microsoft Office and database systems
Preferred
Experience with multi-site CSV initiatives or harmonizing validation efforts across locations
Worked closely with clients or external stakeholders in a validation or compliance role
Familiarity with Data Integrity practices and Validation SOP development
Benefits
Competitive compensation and benefits
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