Sr Mechanical Engineer II

Remote Full-time
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities Design & Technical Engineering Lead and review the design of mechanical systems. Review, improve, and interpret engineering drawings, specifications, control sequences, P&IDs, and equipment submittals. Develop, implement, and maintain programs and processes to ensure high-quality design and operations, and compliance with CBC, CFC, CMC, cGMPs, GEPs, and GLPs. Collaborate with Maintenance and Operations to ensure equipment maintenance, safety inspections, analyses, and audits are conducted as specified. Report project status and adhere to established guidelines and policies. Facility Operations & System Ownership Serve as technical owner for major building systems, including: Required systems: HVAC, chilled water, heating hot water, cold rooms, clean rooms, environmental chambers, fire protection, plumbing. Desired systems: RO/DI, WFI, PW, USP water systems, wastewater neutralization, CDA, compressed air, specialty gases, vacuum systems. Provide operational engineering support and act as SME on utility systems. Troubleshoot and perform root-cause analysis for system deviations and failures. Define and implement CAPAs for long-term system reliability. Review facility systems capacity planning and trending. Partner with Facilities Maintenance and Operations for audits, condition assessments, and SOP development. Collaborate on project justification packages for mechanical systems, incorporating ROI, total cost of ownership, reliability, and energy efficiency. Strong knowledge of building automation systems preferred. Construction & Project Management Lead design phase of capital and operational projects from concept through closeout. Coordinate with architects, engineers, contractors, and vendors during design, construction, and commissioning. Oversee field inspections and support punch list closeout. Commissioning & Validation Support start-up activities for construction projects. Develop Cx protocols, URSs, SOPs, IQ/OQ activities, and PQ for mechanical and utility systems. Ensure documentation meets GMP, regulatory, and quality standards. Leadership & Collaboration Mentor and guide junior engineers or direct reports. Manage contractors to ensure safe, compliant, and efficient execution of work. Collaborate with Facilities Maintenance, EH&S, Workspace Design, Product Development, Quality, and Research teams. Basic Qualifications Bachelor’s degree in Mechanical Engineering or related field with at least 8 years of mechanical engineering experience in R&D facilities, pharmaceutical, biotech, or other cGMP environments. OR Master's degree in Mechanical Engineering or related field with at least 6 years of mechanical engineering experience in R&D facilities, pharmaceutical, biotech, or other cGMP environments. Proven experience with critical utility systems. Demonstrated proficiency in: Core engineering fundamentals. HVAC (cooling/heat load, airflow balance, pressure cascade, fan curves, duct sizing, static pressure calculations). Hydronics (chilled/hot water system design, pump head calcs, NPSH, pipe sizing). High Purity Water Systems (RODI/WFI – USP quality, sanitization concepts, loop design). Controls and Instrumentation (P&IDs, control logic diagrams, SOOs, PID tuning basics, BMS/PLC integration). Utility capacity modeling. Root cause analysis and troubleshooting. Commissioning, startup, and qualification of mechanical systems. Managing vendors, contractors, or direct reports. Applicable codes and standards (CBC, ASHRAE, NFPA, SMACNA, AMCA, FDA CFR, ISO). Preferred Qualifications Experience with GMP compliance, quality systems, or deviation management. Familiarity with Lean, Six Sigma, or continuous improvement methodologies. Professional Engineering (PE) license or progress toward licensure. Experience with CMMS, BMS/EMS/HMS platforms, and facility monitoring systems. Key Soft Skills Strong communication and presentation skills, including ability to interface with senior leadership. Ability to lead cross-functional teams and manage competing priorities. Strategic problem-solving with a continuous improvement mindset. High degree of ownership, accountability, and independent decision-making. Strong teamwork mindset and adaptability. Job Requirements Job Type: Full-time, On-site (5 days/week) Location: Foster City, CA Physical Requirements: Ability to work on construction sites with PPE, lift up to 25 lbs, climb ladders/stairs, and visually inspect job sites. Travel: Apply Now

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