Senior Manager EHSS
About the role
Syngene International Ltd., established in 1993, is an innovation-focused global organization providing integrated scientific services to industries including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a team of over 6,500 scientists, Syngene serves world-leading clients such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. This role ensures robust Environment, Health, Safety, and Sustainability (EHSS) governance at Syngene USA’s Bayview site, focusing on process and occupational safety, compliance, and protection of employees, contractors, communities, clients, assets, and the environment in a high-hazard, cGMP biopharmaceutical manufacturing setting. The position may also contribute to enterprise EHS strategies and initiatives.
Responsibilities
- EHSS Governance, Compliance & Reporting:
- Ensure compliance with OSHA, EPA, DOT, NFPA, NIH/CDC, State of Maryland, and local regulations.
- Own EHSS metrics, dashboards, statutory reporting, and digital records using SAP S/4HANA EHS or equivalent.
- Drive Serious Injury & Fatality (SIF) prevention programs and governance reporting.
- Client Interface & Audit Readiness:
- Act as primary EHSS interface for client due diligence, regulatory inspections, and customer audits.
- Lead audit readiness, response management, and CAPA closure.
- Demonstrate EHSS maturity aligned with leading US biopharma CDMO expectations.
- Operational EHSS & High-Risk Management:
- Support day-to-day EHSS operations for manufacturing, labs, utilities, warehouses, and projects.
- Lead Behavior-Based Safety (BBS) programs with a focus on SIF prevention.
- Manage contractor safety, permit-to-work systems, and high-risk activities.
- Process Safety & Functional Safety:
- Lead PHA, HAZOP, What-If, JHA, and Management of Change (MOC) risk assessments.
- Apply functional safety (SIL concepts), process safety controls, and engineered safeguards.
- Conduct thermal safety studies, dust explosivity analysis, vapor/gas hazard assessment, and chemical reaction criticality evaluation.
- Identify and oversee Management of Safety Critical Equipment (MoSCEs).
- Machinery & Equipment Safety:
- Act as Certified Machinery Safety Expert (CMSE).
- Apply Design for Safety principles and lifecycle machinery risk assessments.
- Support automation, interlocks, guarding, and validation for safety-related control systems.
- Industrial Hygiene & Occupational Health:
- Execute quantitative industrial hygiene exposure assessments.
- Manage respiratory protection programs, including fit testing.
- Partner with Occupational Health on surveillance and exposure mitigation.
- Biosafety & Specialized Risks:
- Ensure compliance with biosafety (BSL), containment, and decontamination requirements.
- Risk assess biological agents, cell culture, viral, and microbial operations.
- Environmental & Transportation Safety:
- Manage air emissions, wastewater, hazardous, and biological waste streams.
- Oversee environmental control technologies (vent gas scrubbers, ETP systems).
- Ensure DOT transportation safety compliance for hazardous materials.
- Emergency Preparedness & Assurance:
- Lead fire risk assessments, emergency drills, and life safety system oversight.
- Conduct hazardous area classification (NEC/ATEX-equivalent risk assessments).
- Perform internal audits and EHSS assurance reviews.
Requirements
- Bachelor’s degree in engineering or science (Chemistry, Biology, Environmental, or related field).
- Master’s degree preferred.
- 8–10 years of EHSS experience in biopharma, pharmaceutical, chemical, or CDMO manufacturing environments.
- Strong experience in process safety, audits, contractor safety, and client-facing roles.
Qualifications
- Postgraduate accredited certification in Industrial Safety/Process Safety.
- Certified Safety Professional (CSP) – Required/Highly Preferred.
- Certified Machinery Safety Expert (CMSE – TÜV or equivalent).
- Functional Safety (SIL) Training.
- Certified Industrial Hygienist (CIH) – desirable.