ERM is seeking an experienced Health and Safety Manager, Startup and Validation to support a major pharmaceutical manufacturing startup in Lebanon, Indiana . This individual will serve as a senior HSE and process safety advisor supporting a large-scale capital project through design, construction, commissioning, qualification, and production startup. The role provides EHS-by-design input, technical guidance on simultaneous operations (SIMOps) and high-risk construction and commissioning activities, and senior review of Pre-Startup Safety Reviews (PSSRs), Process Hazard Reviews (PHRs), PHAs, HAZOPs, and Management of Change (MOC) activities as systems move from construction to operational control. The successful candidate will partner closely with HSE, Engineering, Construction, C&Q, Operations, Maintenance, Quality, and Process Control teams to identify and resolve startup risks early, while serving as a senior technical resource and mentor who brings lessons learned from previous capital-project startups. Access to ERM's national EHS experts provides knowledge sharing of best practices across the industry and ongoing learning opportunities for our team. This is a full-time (40hrs/week), limited-term role for a duration of 12 months, extendable .
Key Responsibilities
Roles & Responsibilities
Serve as a senior HSE and process safety advisor supporting a large-scale capital project through design, construction, commissioning, qualification, and production start-up.
Provide EHS-by-design input during design finalization and field execution, identifying residual risks and evaluating design changes as systems transition toward operation.
Provide technical guidance on simultaneous operations (SIMOps) involving construction, commissioning, qualification, and early production activities.
Support Pre-Startup Safety Reviews (PSSRs), including readiness reviews, field walkdowns, identification of gaps, and follow-up of findings.
Participate in and provide peer review of Process Hazard Reviews (PHRs), PHAs, HAZOPs, and other risk assessments for equipment, processes, and systems moving through commissioning and start-up.
Provide senior technical input on Management of Change (MOC) activities, including risk classification, technical completeness, and closure.
Advise on HSE and process safety considerations associated with mechanical completion, system turnover, energization, commissioning, and transition from construction to operational control.
Provide technical guidance on high-risk construction and commissioning activities, including LOTO, hot work, confined space entry, excavation, contractor interfaces, and life-safety systems.
Partner with HSE, Engineering, Construction, C&Q, Operations, Maintenance, Quality, and Process Control teams to proactively identify and resolve start-up risks.
Serve as a senior technical resource and mentor, applying lessons learned from previous capital-project start-ups and supporting effective transfer of knowledge to site teams.
Requirements
Bachelor’s degree in Chemical, Environmental, Mechanical, or Safety Engineering, or a related technical discipline; equivalent relevant experience may be considered.
10+ years of relevant HSE, process safety, engineering, or capital-project experience within pharmaceutical, chemical, life sciences, or other complex manufacturing environments.
Hands-on experience supporting at least one major pharmaceutical or chemical capital-project start-up, including construction, commissioning, start-up, and transition to operations. Multiple major start-ups strongly preferred.
Demonstrated experience with EHS-by-design/design safety reviews and the ability to assess engineering designs, equipment, systems, and design changes from an HSE and process safety perspective.
Experience managing SIMOps risks involving concurrent construction, commissioning, qualification, and operational activities.
Significant experience with PSSRs and PHRs/PHAs/HAZOPs or comparable structured…