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

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 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 operate independently as a senior technical advisor, identifying gaps, challenging assumptions, and providing practical risk-based recommendations to project leadership.
• Strong communication and collaboration skills across HSE, Engineering, Construction, C&Q, Operations, Quality, and Process Control organizations.

Preferred Qualifications

• Pharmaceutical, biotechnology, or other highly regulated manufacturing capital-project experience.
• Experience supporting multiple greenfield, brownfield, or large-scale facility start-ups.
• 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.

Who We Are: 
As the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. 

At ERM we know that creating a diverse, equitable and inclusive work environment is an essential part of making our company a great place to build a career. We also see our diversity as a strength that helps us create better solutions for our clients. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues. We call this capability our “boots to boardroom” approach for its comprehensive service model that allows ERM to develop strategic and technical solutions that advance objectives on the ground or at the executive level. 

Please submit your resume and brief cover letter.  

ERM does not accept recruiting agency resumes. Please do not forward resumes to our jobs alias, ERM employees or any other company location. ERM is not responsible for any fees related to unsolicited resumes. 

ERM is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.  

Thank you for your interest in ERM!