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Principal Project Engineer

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GSK

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Location:
United States , Rockville

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

136125.00 - 226875.00 USD / Year
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Job Description:

The Principal Project Engineer’s function at the Rockville Biopharm site is to provide technical engineering and subject matter expertise for the Capital Project group in areas of renovation, new construction and installation of facility related equipment in a biopharmaceutical manufacturing space.

Job Responsibility:

  • Act as the lead technical consultant for medium-to-large-scale capital investments (e.g. facility expansions, renovation and new construction). You will approve technical specifications and ensure designs meet both process requirements and regulatory standards
  • Manage the full project lifecycle from conceptual design (Basis of Design) through Detailed Design. This includes overseeing external Architecture and Engineering (A&E) firms to ensure deliverables meet site standards
  • Provide deep-dive expertise in upstream / downstream processing, clean utilities (WFI, clean steam), and HVAC / ISO cleanroom requirements
  • Partner with Project Managers to define scope, estimate costs (Class 1 – 5) and develop execution strategies that minimize disruption to ongoing commercial operations
  • Lead the technical strategy for FAT, SAT and IQ/OQ/PQ. You will be responsible for ensuring the “as-built” system is fully compliant and ready for GMP production
  • Perform technical risk assessment (FMEA) and safety reviews (HAZOP) to identify and mitigate potential design flaws or safety hazards early in the project lifecycle
  • Oversee the overall implementation schedule for assigned capital projects and take necessary action to ensure all assigned capital projects are completed and turned over to internal customers within pre-established deadlines
  • Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and MSAT
  • Demonstrated project management skills (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner
  • Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors

Requirements:

  • BS in Engineering or equivalent technical discipline
  • At least 10 years of experience working in a regulated cGMP biopharmaceutical environment
  • Experience with the design of biopharmaceutical production, quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes
  • Experience with the design of biopharmaceutical production equipment including but not limited to bioreactors, centrifuges, CIP skids, chromatography systems and/or filtration skids
  • Project management experience, including the management of a project by delivering scope, cost and schedule
  • Experience supporting batch and continuous industrial control systems including Delta V

Nice to have:

  • Experience with technical risk assessments and product control strategies
  • Capable of working in a collaborative and team focused environment
  • Demonstrated understanding of ASME BPE and ISPE guides
  • Able to evaluate potential innovative technology areas relevant to products
  • Has a good general background of interior and exterior commercial construction activities with some degree of understanding of all trades to support construction efforts
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Eligibility to participate in our share based long term incentive program
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Paid caregiver/parental and medical leave

Additional Information:

Job Posted:
March 18, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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