Health and Safety Manager, Startup and Validation (Field Based)

ERM•Indianapolis, IN

6d•Onsite

About The Position

ERM is seeking an experienced Health and Safety Manager to support a major pharmaceutical manufacturing startup in Lebanon, Indiana. This field-based role serves as a senior HSE and process safety advisor for a large-scale capital project spanning design, construction, commissioning, qualification, and production startup. The position 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 transition from construction to operational control. The successful candidate will work closely with HSE, Engineering, Construction, C&Q, Operations, Maintenance, Quality, and Process Control teams to identify and resolve startup risks early. They will also serve as a senior technical resource and mentor, applying lessons learned from prior capital-project startups and supporting knowledge transfer to site teams. ERM provides access to national EHS experts for industry best-practice knowledge sharing and ongoing learning opportunities. This is a full-time, 40-hour-per-week, limited-term role for 12 months, with the possibility of extension. The position is field based.

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 in pharmaceutical, chemical, life sciences, or other complex manufacturing environments.
Hands-on experience supporting at least one major pharmaceutical or chemical capital-project startup, including construction, commissioning, startup, and transition to operations.
Demonstrated experience with EHS-by-design/design safety reviews and assessing 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 process-risk assessments.
Strong working knowledge of MOC and construction/commissioning hazards, including energy isolation, system energization, equipment turnover, and contractor interfaces.
Ability to interpret P&IDs, engineering drawings, risk assessments, commissioning documentation, and turnover/readiness packages.
Ability to work independently as a senior technical advisor, identify gaps, challenge assumptions, and provide practical risk-based recommendations to project leadership.
Strong communication and collaboration skills across HSE, Engineering, Construction, C&Q, Operations, Quality, and Process Control organizations.

Nice To Haves

Experience supporting multiple major capital-project startups.
Pharmaceutical, biotechnology, or other highly regulated manufacturing capital-project experience.
Experience supporting multiple greenfield, brownfield, or large-scale facility startups.
Experience with Safety Instrumented Systems (SIS) and/or Distributed Control Systems (DCS).
Previous consulting, contract, or technical advisory experience.
Relevant professional certification such as PE, CFSE, CSP, or CHST.

Responsibilities

Serve as a senior HSE and process safety advisor for a capital project through design, construction, commissioning, qualification, and production startup.
Provide EHS-by-design input during design finalization and field execution; identify residual risks and evaluate design changes as systems transition toward operation.
Provide technical guidance on SIMOps involving construction, commissioning, qualification, and early production activities.
Support PSSRs, including readiness reviews, field walkdowns, identification of gaps, and follow-up of findings.
Participate in and peer-review PHRs, PHAs, HAZOPs, and other risk assessments for equipment, processes, and systems moving through commissioning and startup.
Provide senior technical input on MOC activities, including risk classification, technical completeness, and closure.
Advise on HSE and process safety considerations related to 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 identify and resolve startup risks proactively.
Serve as a senior technical resource and mentor, applying lessons learned from previous capital-project startups and supporting knowledge transfer to site teams.