Sterile Fill Finish Principal Process Engineer

PCI Pharma Services•Bedford, NH

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. We’re looking for a hands-on, highly skilled Principal Process Engineer to lead complex engineering projects from concept to completion. In this role, you’ll be working with state of the art isolated sterile fill finish equipment and supporting plant systems, optimizing and fine tuning equipment performance, and ensure our facilities and utilities run at world-class standards. This is an opportunity to apply your deep technical expertise, mentor other engineers, and play a key role in our capital projects, all while working in a fast-paced, highly regulated environment.

Requirements

Education – BS or MS in Chemical, Mechanical, or related Engineering discipline.
Experience – 10+ years in engineering/facilities/utilities (preferably biotech, medical device, or pharmaceutical).
Technical Expertise – GMP/FDA regulations, aseptic processes, capital project execution, and advanced utilities systems.
Tools & Skills – MS Office Suite, MS Project, AutoCAD/SolidWorks; CMMS, PLC knowledge a plus.
Mindset – Detail-oriented, organized, hands-on, and able to thrive in a fast-paced CMO environment.
Leadership – Proven ability to manage people, projects, budgets, and timelines with strong communication and negotiation skills.
Able to lift/move up to 50 lbs and gown for cleanroom access.
Occasional travel (<10%) between facilities.

Nice To Haves

CMMS, PLC knowledge a plus.

Responsibilities

Lead & Deliver Projects – Oversee the design, procurement, installation, and start-up of new plant utilities, equipment, and systems.
Engineer for Excellence – Optimize performance of packaging equipment and manufacturing systems for maximum efficiency and reliability.
Own the Process – From URS and risk assessments to vendor management and factory/site acceptance testing, you’ll ensure every step meets technical and regulatory requirements.
Be the Go-To Expert – Troubleshoot complex systems (water pretreatment, high-purity water, clean steam, compressed air, nitrogen, HVAC, freeze dryers, fill-finish lines) and keep production running smoothly.
Mentor & Influence – Share your expertise, guide junior engineers, and champion continuous improvement initiatives.
Collaborate Across Teams – Work closely with Manufacturing, Quality, Facilities, Validation, and EHS to align engineering solutions with business needs.