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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. What You'll Be Doing As an Instrumentation Systems Engineer, you'll serve as the go-to expert in QC for analytical and microbiology lab equipment. You'll ensure that all systems are compliant, qualified, and ready to meet the demands of a cGMP-regulated environment. Key Responsibilities:
Own the full lifecycle of QC testing instrumentation: induction, qualification, validation, decommissioning, and beyond Serve as the main point of contact for QC equipment inquiries, coordinating with vendors and internal teams Support multiple QC functions including Analytical, Microbiology, Analytical Development, and Sample Management Manage quality records (deviations, investigations, CAPAs, MOCs) from initiation to closure Coordinate with validation, calibration, and metrology teams to ensure equipment is always audit-ready Evaluate instrument performance and lead efforts for repair, replacement, or upgrades Author and maintain SOPs, and ensure alignment with global, local, and regulatory standards Drive improvements in method optimization and equipment functionality Support internal and external audit preparation, and stay updated on USP, EP, JP, and FDA regulations
What You Bring to the Role
Bachelor's degree in a science, engineering, or related technical field Up to 5 years of experience in a regulated GMP laboratory or manufacturing environment Solid understanding of cGMP, GAMP, GxP, SDLC, and 21 CFR Part 11 Hands-on experience troubleshooting complex analytical or microbiology equipment Familiarity with computer systems validation and equipment software Excellent organizational and technical writing skills Strong cross-functional collaboration and communication abilities Experience with database systems and Microsoft Office Suite Ability to prioritize, manage multiple tasks, and lead small to mid-sized projects
#LI-LL1 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.
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PCI Pharma Services
Jul 07, 2025