Senior Process Engineer

Gilead Sciences

Global Process Engineer ensuring consistency and excellence in biopharmaceutical manufacturing processes. Leading initiatives across multiple sites for improved quality and efficiency.

Posted 6/3/2026full-timeOceanside • California, Maryland • 🇺🇸 United StatesSenior💰 $153,935 - $199,210 per yearWebsite

About the role

Key responsibilities & impact

own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
conduct global change control impact assessments to ensure process consistency across the network
support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization
lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
contribute to Global MSAT project portfolio strategy, prioritization, and execution
drive cross-functional alignment and ensure reliable execution of network-level initiatives
lead global investigations across sites to identify root causes and implement sustainable solutions
develop and implement standard investigation frameworks and playbooks
ensure adherence to global governance and change management processes to support process harmonization
act as a site-agnostic process expert, supporting alignment of site activities with network strategy
partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
support process harmonization and implementation of best practices across sites

Requirements

What you’ll need

Bachelor's Degree in Engineering, Biotechnology or Life Sciences with 8+ years of experience in pharmaceutical/biotech manufacturing, process development or process engineering OR Masters in Engineering, Biotechnology or Life Sciences with 6+ years of experience in the same fields
expertise in process equipment and engineering
technology transfer or pharmaceutical manufacturing experience
expertise in viral vector manufacturing is a plus
cell culture, cell therapy or aseptic processing experience
experience in equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
experience in Project Management and Project Management Methodology
strong understanding of GMP environment and change control processes
experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)
proactive and willing to accept temporary responsibilities outside of initial job description
experience in engineering in highly regulated manufacturing environments

Benefits

Comp & perks

discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
company-sponsored medical, dental, vision, and life insurance plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

process documentationprocess control strategyprocess FMEAschange control impact assessmentsstandardized documentationinvestigation frameworkstechnology transferviral vector manufacturingcGMP environmentProject Management

Soft Skills

cross-functional alignmentleadershipproblem solvingcommunicationproactive attitude

Certifications

Bachelor's Degree in EngineeringBachelor's Degree in BiotechnologyBachelor's Degree in Life SciencesMaster's Degree in EngineeringMaster's Degree in BiotechnologyMaster's Degree in Life Sciences