QC Laboratory Instrumentation Specialist I/II

PCI Pharma Services • Bedford, NH

1d

About The Position

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 Specialist, 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.

Requirements

• 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

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 This Job Offers

• Job Type: Full-time
• Career Level: Entry Level