• QC Laboratory Instrumentation Engineer I/II

    PCI Pharma Services (Bedford, NH)


    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 (https://pci.com/)

    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._

     

    Why work for PCI Pharma Services?

     

    At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

     

    PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled