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About the Role
The Manager, Process Safety leads and improves the site's Process Safety Management (PSM), Electrical Safety, and Energy Control programs. This role serves as the Subject Matter Expert (SME) for process safety and operational risk management, ensuring regulatory compliance and supporting safe manufacturing operations. The position is also the lead HSE contributor for maintaining LOTTE’s ISO 45001 certification.
Responsibilities
- Serve as the site Subject Matter Expert (SME) for Process Safety Management (PSM), Electrical Safety, and Energy Control (LOTO) programs.
- Lead the implementation, maintenance, and continuous improvement of site Process Safety Management programs to ensure compliance with OSHA PSM, EPA Risk Management Program (RMP), NFPA requirements, and company standards.
- Facilitate Process Hazard Analyses (PHA), HAZOP studies, risk assessments, and other structured hazard evaluation processes to identify, assess, and mitigate operational risks.
- Manage the site's Management of Change (MOC) program, ensuring health, safety, environmental, quality, and operational risks are appropriately evaluated and controlled prior to implementation.
- Partner with Operations, Engineering, Facilities, Maintenance, and Quality teams to integrate process safety principles into manufacturing operations and business processes.
- Support the design, installation, startup, qualification, and modification of manufacturing equipment, utility systems, facilities, and processes to ensure safety and regulatory requirements are met.
- Administer and continuously improve Electrical Safety and Energy Control programs, including Arc Flash assessments, Lockout/Tagout compliance, training programs, and risk mitigation activities.
- Lead process safety reviews associated with new technologies, capital projects, process modifications, and equipment installations.
- Coordinate internal and external ISO45001 audits with third-party consultants and internal resources.
- Contribute to other ISO certifications as assigned.
- Execute industrial hygiene exposure monitoring in coordination with the site’s Industrial Hygienist.
- Act as the HSE representative for client projects as assigned.
- Conduct compliance audits, inspections, program assessments, and field observations to evaluate effectiveness of safety controls and identify opportunities for improvement.
- Lead or facilitate incident investigations, root cause analyses, and development of corrective and preventive actions (CAPAs) related to safety, process safety, and operational events.
- Monitor, analyze, and report process safety and HSE metrics, key performance indicators (KPIs), and leading indicators to drive continuous improvement.
- Maintain regulatory records, compliance documentation, and required reports for internal and external stakeholders.
- Support contractor safety and qualification programs to ensure adherence to company safety requirements and industry best practices.
- Serve as a site representative during regulatory inspections, customer audits, and corporate assessments related to process safety and HSE compliance.
- Deliver technical training, coaching, and guidance on process safety, hazard recognition, risk mitigation, and regulatory requirements.
- Participate in emergency response planning and provide technical support during emergency events and operational incidents.
- Stay current with emerging process safety technologies, regulatory developments, and industry best practices to enhance site performance.
- Support the Senior Manager, HSE with departmental objectives, strategic initiatives, budgeting activities, and continuous improvement efforts.
- Participate on cross-functional teams, committees, and corporate initiatives as required.
- Perform other duties as assigned.
Requirements
- Bachelor's degree in Environmental Health & Safety, Engineering, Industrial Hygiene, Chemistry, Biology, Occupational Health, or a related discipline required.
- 7+ years of experience in Process Safety, Health, Safety & Environment (HSE), Operational Risk Management, or HSE program leadership within pharmaceutical, biologics, biotechnology, chemical, or other highly regulated manufacturing environments.
- Demonstrated success leading risk assessments, process safety initiatives, incident investigations, and regulatory compliance programs.
- Experience supporting enterprise-wide process safety and operational risk initiatives across complex manufacturing operations.
- Knowledge of Arc Flash hazards, electrical safety, and NFPA 70E compliance programs preferred.
- Ability to sit, stand, walk, climb stairs and ladders, and traverse manufacturing, utility, warehouse, and office areas for extended periods.
- Ability to conduct field inspections, audits, risk assessments, and incident investigations in operating manufacturing environments.
- Ability to wear required personal protective equipment (PPE) and comply with site safety requirements.
- Ability to lift, carry, push, and pull up to 25 pounds occasionally.
- Ability to access confined or restricted industrial spaces, elevated work areas, and outdoor locations when required and in accordance with site safety procedures.
- Ability to respond to emergencies, incidents, and business-critical situations, including occasional after-hours support for a 24/7 manufacturing operation.
- Ability to travel between facilities and vendor or contractor locations as business needs require.
Skills
- Strong knowledge of OSHA Process Safety Management (PSM), EPA Risk Management Program (RMP), NFPA standards, Electrical Safety, and Energy Control (LOTO) requirements.
- Experience conducting Process Hazard Analyses (PHA), HAZOPs, risk assessments, incident investigations, and Management of Change (MOC) reviews.
- Experience with the ISO45001 standard and maintaining a certified occupational health and safety management system.
- Familiarity with standard industrial hygiene monitoring techniques including noise dosimetry, air sampling, and real-time monitoring instruments.
- Working knowledge of cGMP requirements and pharmaceutical, biologics, biotechnology, or regulated manufacturing environments.
- Strong understanding of risk management methodologies and operational excellence principles.
- Ability to analyze complex technical issues and develop practical risk-based solutions.
- Strong leadership, project management, organizational, and influencing skills.
- Excellent written, verbal, and presentation communication skills.
- Proficiency with Microsoft Office applications and HSE management systems.
- Experience utilizing data analytics, performance metrics, and reporting tools to drive continuous improvement.
- Ability to work independently and effectively within cross-functional teams.
- Korean language proficiency is beneficial but not required.
Location
- East Syracuse, NY
Work Type
- Onsite
Experience Level
- 7+ years of experience
Education Level
- Bachelor's degree
Salary/Compensations
- $76,000—$113,000 USD
Benefits
- 10% Target Bonus
About the Company
- We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
- A new company, built on 80 years of tradition.
- We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives.
- Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Equal Opportunity
- We are an Equal Employment Opportunity (“EEO”) Employer.
- We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!
- If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!