Principal Project Engineer

GSK•Rockville, MD

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary 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.

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 Haves

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.

Responsibilities

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.