Process Engineer Job at Premier Life Sciences LLC, New Hampshire

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  • Premier Life Sciences LLC
  • New Hampshire

Job Description

What You’ll Do

Technology Transfer

  • Lead and coordinate the full lifecycle of tech transfer from development to manufacturing.
  • Collaborate with cross-functional teams to ensure all process knowledge and documentation are effectively communicated to the CMO.
  • Conduct facility fit assessments and system walk-downs to validate equipment and process readiness.

Process Engineering

  • Manage upstream processes, particularly mammalian cell culture at 2000L scale in single-use or stainless-steel bioreactors.
  • Oversee downstream purification operations including chromatography, ultrafiltration, and sterile filtration.
  • Support implementation of PAT (Process Analytical Technology) tools to enable real-time process monitoring and control.

GMP and Validation

  • Draft and execute IQ/OQ/PQ protocols for new or transferred equipment and systems.
  • Support QA in handling change controls, deviations, and CAPAs aligned with FDA and ICH guidelines.
  • Ensure compliance with all applicable cGMP regulations and internal quality systems.

Data & Documentation

  • Review and analyze process data to identify trends, troubleshoot issues, and support continuous improvement.
  • Prepare high-quality documentation including SOPs, validation reports, and batch records.

Cross-functional Collaboration

  • Act as a liaison between internal technical teams and external CMOs to ensure alignment on project deliverables.
  • Participate in joint project planning, risk assessments, and technical discussions.

Required Qualifications

  • Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
  • Minimum 5 years of experience in process engineering within the biopharmaceutical industry , with hands-on experience in mAb manufacturing .
  • Direct experience in technology transfer to CMOs.
  • Strong understanding of GMP requirements and bioprocess validation.
  • Proficient in working with large-scale bioreactors (2000L) and downstream unit operations.

Preferred Qualifications

  • Familiarity with single-use technologies and disposable bioprocessing systems.
  • Knowledge of regulatory submissions (e.g., IND, BLA).
  • Experience with statistical tools for process monitoring and optimization (e.g., JMP, Minitab).

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