ERM is seeking an experienced
Startup and Validation EHS Program Manager to support a major pharmaceutical manufacturing startup in
Lebanon, Indiana. This individual will provide onsite leadership for health, safety, and environmental activities associated with commissioning, qualification, startup, and operational readiness of manufacturing systems and supporting infrastructure. The role serves as the primary HSE leader for startup activities and oversees a team of Node Leads and HSE professionals supporting multiple facility areas.
The successful candidate will partner closely with client leadership, startup teams, engineering organizations, and operations personnel to ensure safe startup execution, effective lockout/tagout (LOTO) programs, safe work permits (SWP), startup readiness reviews, incident prevention, and continuous improvement initiatives. Access to ERM's national EHS experts provide 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 2.5 years (30 months), extendable.
Key ResponsibilitiesLeadership & Program Oversight- Provide day-to-day leadership for the onsite C&Q HSE team, comprised of 6-8 project leads and specialists.
- Establish consistent HSE expectations, processes, and field practices across all startup areas.
- Mentor and support Node Leads and HSE professionals.
- Interface directly with client startup leadership and project stakeholders.
- Lead coordination meetings and drive accountability for HSE deliverables.
Startup Safety & Operational Readiness- Support safe commissioning, qualification, and startup of manufacturing systems.
- Participate in startup planning, readiness reviews, and operational transition activities.
- Support execution of pre-startup reviews for safety and environmental considerations.
- Identify startup risks and develop practical mitigation strategies.
- Provide field presence during critical startup evolutions.
LOTO & High-Risk Work Management- Maintain and continuously improve LOTO and SWP strategies, standards, and guidance.
- Support development and review of complex isolation plans.
- Audit LOTO and SWP implementation and compliance.
- Provide oversight of high-risk work activities conducted during startup and commissioning.
Metrics, Auditing & Continuous Improvement- Develop and report startup safety performance metrics.
- Conduct program audits and field assessments.
- Identify trends and opportunities for improvement.
- Drive closure of corrective actions and develop lessons learned.
Incident Investigation- Lead investigations of incidents, near misses, and significant safety observations.
- Facilitate root cause analysis efforts.
- Develop corrective and preventive actions.
- Communicate lessons learned across project teams.
Environmental Support- Coordinate with commissioning and qualification personnel, environmental specialists, and site personnel regarding startup-related environmental requirements.
QualificationsQualifications- Bachelor's degree in Safety, Engineering, Environmental Science, Industrial Hygiene, Occupational Health, or related discipline preferred
- 10+ years of EHS experience.
- Minimum 5 years supporting one or more of the following:
- Commissioning
- Qualification
- Startup
- Operational readiness
- Manufacturing operations
- Capital projects
- OSHA 30-Hour certification.
- Experience leading EHS professionals, contractors, or project teams.
- Experience with:
- Lockout/Tagout programs
- Incident investigations
- Permit-to-work systems
- Risk assessments
- Job Hazard Analyses (JHAs/JSAs)
- Ability to work full-time onsite in Lebanon, Indiana.
Preferred Qualifications- Pharmaceutical, biotech, chemical, semiconductor, battery manufacturing, or API manufacturing experience.
- Startup or commissioning experience in regulated manufacturing environments.
- CSP, PE, CHMM, CIH, or equivalent certification.
- Experience with:
- Pre-Startup Safety Reviews (PSSR)
- Management of Change (MOC)
- Process Safety Management (PSM)
- Process Hazard Analysis (e.g., HAZOP) participation
- Contractor safety programs
- Previous owner-side, embedded advisor, or secondment experience.
- Experience supporting greenfield manufacturing projects.
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.
