Manager, Process Safety

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.

The Manager, Process Safety is responsible for leading and continuously improving the site's Process Safety Management (PSM), Electrical Safety, and Energy Control programs. This position serves as the site Subject Matter Expert (SME) for process safety and operational risk management, ensuring compliance with applicable federal, state, and local regulations, industry standards, and company policies while supporting safe, reliable, and compliant manufacturing operations.

Additionally, this position will be the lead HSE contributor for maintenance of LOTTE’s International Organization for Standardization (ISO) 45001 certification.

The position partners closely with Operations, Engineering, Facilities, Maintenance, Quality, Validation, and Corporate HSE to identify, assess, and mitigate risks associated with manufacturing processes, utilities, equipment, and facility operations. This position drives a proactive safety culture through technical expertise, risk-based decision-making, regulatory compliance, and continuous improvement initiatives.

This position must comply with all Security requirements, Health, Safety, and Environment (HSE) regulations, and current Good Manufacturing Practices (cGMPs) applicable to the job function.

• 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. /li
• Coordinate internal and external ISO
  45001 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…