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Drug Product Principal Process Engineer

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PCI Pharma Services

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Location:
United States , Bedford

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • BS or MS in Chemical, Mechanical, or related Engineering discipline
  • 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
What we offer:
  • Work on mission-critical projects that directly support life-saving products
  • Lead with impact – influence strategy, mentor engineers, and shape facility capabilities for years to come
  • Be part of a collaborative, safety-focused culture where engineering is a driver of innovation, not just maintenance
  • Competitive compensation, benefits, and opportunities for career growth

Additional Information:

Job Posted:
January 02, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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