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Principal Technical Sub-Project Manager (Drug Product Filling & Compounding Equipment)

roche · Hillsboro

New
Onsite Senior 109,900 - 204,100 USD/year 🇬🇧 English
FAT/SAT Commissioning Qualification GMP FDA EMA

Job description

About the role

This role sits within the Equipment Engineering team, which delivers drug product filling and compounding systems that ensure safe, efficient and compliant pharmaceutical manufacturing. As Principal Technical Sub-Project Manager, you will lead and manage the technical execution of sub-projects, working with global stakeholders, equipment manufacturers and multidisciplinary project teams to deliver capital projects. The position is on-site in Oregon, with no remote option.

Key responsibilities

  • Plan, design and implement mechanical and process engineering projects independently, in line with Roche Guidelines, Global Standards and Health Authority requirements.
  • Manage the approved sub-project budget and schedule, set priorities and report regularly on progress, risks, mitigations and escalations.
  • Act as the main interface with equipment manufacturers, covering technical specifications, design reviews, performance validation and compliance.
  • Lead and coordinate FATs, SATs, commissioning and qualification activities.
  • Direct and manage external engineering firms, service providers and contractors.
  • Guide project scope, including options analysis, planning, detailed scheduling and resource allocation.
  • Mentor and coach less experienced engineers.

Required profile

  • Bachelor's degree in Mechanical or Chemical Engineering or a related field with 8+ years of experience, or a Master's degree with 6+ years in pharmaceutical/biopharmaceutical filling and compounding equipment; an MS in Engineering and/or an MBA is preferred.
  • Extensive experience managing international capital projects for filling and compounding equipment, typically with budgets of 18 to 60 million USD.
  • 8+ years of hands-on experience with filling and compounding systems, including aseptic filling, lyophilization, vial/syringe filling and aseptic compounding.
  • Proven experience with equipment manufacturers, FAT/SAT leadership and commissioning and qualification.
  • Knowledge of FDA, EMA and GMP requirements for filling and compounding operations.
  • Significant travel (50%+), including weekly commuting or temporary remote work, and international project assignments of 1 to 3 years as needed.

What we offer

  • Expected salary range of $109,900 to $204,100, depending on experience, qualifications and location.
  • A discretionary annual bonus based on individual and company performance.
  • The position qualifies for the benefits described in the original listing.

Questions fréquentes

Le salaire proposé pour ce poste est de 110-204k USD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 16 hours ago

Expires 1 month from now

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roche

Hillsboro