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Specialist II - Manufacturing Science and Technology
Specialist II - Manufacturing Science and TechnologyPCI Pharma Services • Bedford, NH, USA
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Specialist II - Manufacturing Science and Technology

Specialist II - Manufacturing Science and Technology

PCI Pharma Services • Bedford, NH, USA
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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 Do

As a key player in our manufacturing technical team (MTS) you’ll be the bridge between operations, quality, and our clients. Your mission : ensure smooth tech transfers, support GMP production, and help drive continuous improvement across aseptic and non-aseptic processes, including fill / finish and device manufacturing.

In this role, you’ll :

  • Serve as a technical SME during new process tech transfers
  • Author and revise Batch Records, SOPs, and manufacturing documentation
  • Investigate and resolve manufacturing issues to support cGMP compliance
  • Participate in root cause analysis, CAPAs, and risk assessments
  • Provide on-the-floor support and training to Operations staff
  • Collaborate with clients to align manufacturing documents and materials
  • Support implementation of new materials / processes and manage deviations
  • Help promote a strong safety culture through active involvement in EHS programs

What You Bring

You’re a detail-driven, solution-focused professional with :

  • 3+ years of experience in GMP manufacturing, technical operations, or a regulated industry. A degree in Life Sciences, Engineering, or a related field (Associate’s or Bachelor’s) is preferred but not required. Equivalent relevant work experience will be considered in lieu of a degree.
  • Experience with pharmaceutical, biotech, or medical device operations
  • Knowledge of aseptic techniques, cGMP, FDA QSR, or ISO 13485
  • Strong technical writing abilities (SOPs, investigations, batch records)
  • Familiarity with deviation / CAPA systems and cleanroom procedures
  • Proficiency in Microsoft Office and a knack for documentation accuracy
  • Bonus Points If You Have :

  • Hands-on experience with GMP-scale equipment
  • Background in formulation, filtration, or filling operations
  • Training experience or a leadership mindset in cross-functional settings
  • The Environment You’ll Work In

    Expect a fast-paced, collaborative atmosphere where no two days are the same. You’ll interface with :

  • Manufacturing and project teams
  • Clients and quality representatives
  • Facilities, engineering, and validation departments
  • Work may include time in cleanrooms (aseptic and non-aseptic areas) and extended standing or light equipment handling (lifting up to 50 lbs).

    Travel

    Minimal (

    Why PCI?

    At PCI, you won’t just be part of a team — you’ll help build the future of contract development and manufacturing. We offer :

  • Opportunities to grow in a rapidly evolving CDMO environment
  • Direct impact on critical product launches
  • A culture that values curiosity, collaboration, and accountability
  • #LI-LL1

    Join us and be part of building the bridge between life changing therapies and patients.

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    Technology Specialist • Bedford, NH, USA

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