Sr. Principal - Engineer - HSE (Process Safety)

Eli Lilly US, Houston TX Updated 11 September 2026
PharmaPharmacovigilanceRegulatory AffairsQuality Assurancegmpsasemacroraveinform

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Job Position Overview: Lilly is constructing an advanced manufacturing facility for the production of API molecules intended to support current and future products, including new modalities. The Process Safety Engineer provides technical expertise in process safety management and engineering support across all phases of site development. During construction, commissioning, qualification, pre-startup, and startup, this role will partner with Project Delivery, Engineering, Operations, Maintenance, Quality, and HSE teams to help establish the systems, processes, and practices necessary to support safe and compliant GMP manufacturing operations. After startup, the role will transition into an operational process safety position supporting API manufacturing, with primary focus on sustaining process safety management systems, providing technical support for high-risk process safety activities, and contributing to continuous improvement across site operations. Responsibilities: Pre-Startup and Startup Phase · Support development and implementation of core process safety management elements required for site readiness, including but not limited to Employee Participation, Management of Change, Pre-Startup Safety Review, Process Hazard Analysis, operating procedure integration, and process safety information management. · Provide process safety technical input during facility design, construction, commissioning, qualification, and startup to ensure hazards are identified, risks are evaluated, and controls are incorporated before transition to GMP operations. · Support Process Hazard Analyses, HAZOP studies, What-If reviews, Layer of Protection Analysis, facility siting assessments, combustible dust evaluations, and related risk studies, ensuring findings are documented, tracked, and mitigated. · Partner with Engineering, Operations, Maintenance, Quality, and HSE teams to integrate process safety requirements into startup readiness plans, training, procedures, equipment handover, and operational governance processes. · Support onboarding, training, and knowledge-sharing activities to build process safety competency and reinforce safe work practices as the organization, systems, and work processes are being built. Post-Startup Phase · Provide process safety technical support for API manufacturing operations to help ensure ongoing process safety compliance, effective risk management, and reliable execution of established PSM programs. · Sustain and continuously improve PSM elements, including Management of Change, Process Hazard Analysis revalidation, Pre-Startup Safety Review, mechanical integrity interfaces, operating procedure updates, training, and incident investigation support. · Support high-risk operational activities by providing process safety guidance for changes, deviations, abnormal operations, shutdowns, startups, maintenance activities, and simultaneous operations. · Monitor process safety performance through audits, field engagement, corrective action follow-up, incident learnings, management review inputs, and key performance indicators. · Maintain technical relationships with corporate and site process safety teams and engage externally with industry organizations such as CCPS, P2SAC, and ACC process safety groups to stay current with best practices. Basic Qualifications: Education Level: bachelor’s degree in chemical engineering, Chemistry, or related field of study. Experience: Minimum of 3 years of experience in chemical or pharmaceutical manufacturing, with demonstrated knowledge of process safety RAGAGEP including OSHA, 1910.119 NFPA, EPA RMP standards Process Safety Management (PSM) regulation. Licenses: N/A Language Requirements: N/A Required Skills Testing: N/A ​Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Skills/ Preferences: · Certified Process Safety Professional (CCPSC) or Professional Engineer (PE) preferred. · Previous experience with Process Hazard Analysis (PHA), HAZOP, and What-If methodologies, including facilitation of PHA sessions. · Previous experience with Layer of Protection Analysis (LOPA) methodology. · Previous experience interfacing with HSE-related regulatory agencies. · Previous experience with EPA Risk Management Plan (RMP) requirements and administration. · Proven ability to work collaboratively across cross-functional teams and communicate technical process safety concepts effectively to diverse audiences. · Proven ability to apply structured and systematic analytical approaches to complex process safety problems. · Willingness to operate in a dynamic, startup environment requiring creativity, multi-tasking and resilience as organizational systems and culture are being built. Additional Information: This role supports a greenfield facility currently under construction; the scope and day-to-day responsibilities will evolve significantly between the project/startup phase (through approximately 2029–2030) and full GMP operations. · Candidate will contribute technical process safety expertise to site readiness, program development, and operational support activities. · Position Location: US: Ho

Stand out for this role

NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.

Tailor my CV now — free to try