CSV Engineer III

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.

Bonus Points If You Have:

• 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

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.