Principal Process Engineer (Sterile Fill Finish) jobs in United States
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PCI Pharma Services · 1 day ago

Principal Process Engineer (Sterile Fill Finish)

positionBedford, NH
timeFull-time
remoteOnsite
seniorityLead/Staff
date12+ years exp

PCI Pharma Services is a company focused on life-changing therapies and global impact. They are seeking a highly skilled Principal Process Engineer to lead complex engineering projects, optimize equipment performance, and mentor junior engineers in a regulated environment.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

GMP/FDA regulationsAseptic processesCapital project executionAdvanced utilities systemsIsolatorsSterile fill finishLyophilizersMS Office SuiteMS ProjectAutoCAD/SolidWorksOrganizedDetail-orientedHands-onCommunication skillsNegotiation skills

Required

BS or MS in Chemical, Mechanical, or related Engineering discipline
12+ years in engineering/facilities/utilities (preferably biotech, medical device, or pharmaceutical)
GMP/FDA regulations, aseptic processes, capital project execution, and advanced utilities systems
Experience working with one of the following: Isolators, Sterile fill finish, lyophilizers
MS Office Suite, MS Project, AutoCAD/SolidWorks; CMMS, PLC knowledge a plus
Detail-oriented, organized, hands-on, and able to thrive in a fast-paced CMO environment
Proven ability to manage people, projects, budgets, and timelines with strong communication and negotiation skills

Benefits

Competitive compensation, benefits, and opportunities for career growth.

Company

PCI Pharma Services

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PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
dateFounded in 2012
location
Philadelphia, Pennsylvania, USA
people-size5001-10000 employees
web-link
http://www.pciservices.com

H1B Sponsorship

PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed

Leadership Team

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Gil Valadez
Chief Operating Officer
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