Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We’re looking for a CSV Validation Engineer III to join our Quality and Compliance team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems—ensuring everything from equipment to enterprise software meets the highest regulatory and performance standards.
What You’ll Do: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.
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.
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.
You’ll be part of a mission-driven team passionate about quality, compliance, and innovation in the biotech and pharmaceutical space. We offer:
A collaborative work environment where your ideas matter
Opportunities for cross-functional growth and leadership
Competitive compensation and benefits
A chance to shape critical systems that directly impact patient safety and product quality
#LI-AK2
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Skills Required
- 5+ years of hands-on experience in a cGMP-regulated environment
- At least 3 years focused on automation and validation
- Strong knowledge of validation for manufacturing equipment and systems
- Excellent communication and documentation skills
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
