API Manufacturing Process Safety Engineer

Essential Job Duties & Responsibilities

• Build, implement, and continually improve the API Process Safety program in alignment with OSHA PSM, EPA requirements, and Phlow procedures.
• Own and lead PFMEAs, PHAs, and PSSRs for new and existing API processes; translate outcomes into practical engineered and administrative controls for GMP operations.
• Identify and control hazards typical to API operations (e.g., exotherms, overpressure, vacuum collapse, flammable/toxic releases, static, dust deflagration) and ensure safeguards are in place and effective.
• Cook thermal hazard characterization (e.g., DSC/ARC/RC1) and ensure data are integrated into equipment design, operating limits, automation strategies, interlocks, and procedures.
• Develop and support relief and vent strategies (PSVs/rupture discs, vent sizing, scrubbers/containment) and contribute to LOPA/SIL evaluations and verification of assumptions.
• Own the process safety portion of the MOC process by evaluating risk impacts, defining required safeguards, and confirming PSI updates, training, and startup readiness.
• Define mechanical integrity expectations for critical protective systems and instrumented functions; work closely with Maintenance and Engineering to prioritize and validate testing.
• Lead or participate in incident and near-miss investigations related to process and equipment; perform root cause analysis and track corrective/preventive actions to closure.
• Develop and deliver training and coaching for employees and contractors on process safety and life safety requirements related to API manufacturing.
• Collaborate closely with Tech Transfer, GMP Manufacturing GMP Manufacturing Operations, Process Engineering, Quality & Regulatory, Facility Security, and local emergency responders to support drills, pre-incident planning, and safe execution of campaigns.

Requirements

• Bachelor’s degree in Chemical Engineering or a closely related engineering discipline.
• Experience in process safety, chemical engineering, or EHS in manufacturing (pharma/API or chemical processing preferred).
• Practical experience with exothermic/reactive chemistry, overpressure protection, or cryogenic/flammable systems.
• Working knowledge of OSHA/EPA regulations and core PSM elements (PHA/HAZOP, LOPA/SIL concepts, MOC, PSSR, incident investigation).
• Proficiency with process safety tools and documentation (PSI, risk assessments, action tracking).
• Strong analytical and problem-solving skills with the ability to collaborate in cross-functional teams.
• Able to work in a fast-paced environment with regular field presence in manufacturing areas.

Competencies/Skills

• Solid technical proficiency in process safety methods and engineering fundamentals.
• Ability to perform structured risk assessments and recommend practical mitigation strategies.
• Effective communication and interpersonal skills at all organizational levels.
• Strong organizational skills and the ability to manage multiple tasks and priorities.
• Continuous improvement mindset and attention to detail.

Working Conditions

• Work environment includes GMP manufacturing suites, technical areas, and utilities with potential exposure to chemical materials and elevated noise.
• Maintain a high level of awareness for personnel and equipment safety.
• Use of personal protective equipment (PPE) may be required, including respirators, gloves, safety glasses, and protective clothing.
• Physical requirements include work in various positions such as walking, standing, or sitting for prolonged durations, including reaching, bending, twisting, turning, and climbing.
• Exposure to indoor factory conditions and outdoor environments with varying temperatures.
• Ability to lift objects up to 25–35 pounds occasionally.
• Frequent walking, standing, bending, and climbing stairs or ladders to access equipment and platforms.