API Manufacturing Process Safety Engineer

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Description

Phlow Corp is seeking an API Manufacturing Process Safety Engineer to own and build the API Manufacturing Process Safety program from the ground up for small-molecule API manufacturing at the Petersburg, VA campus. This position is directly responsible for the process safety activities associated with technology transfer, process design, and GMP startup, and works hand in hand with the Tech Transfer team and the GMP Manufacturing Operations team to ensure safe, compliant, and reliable operations. The role leads process safety assessments, Management of Change (MOC), and the implementation and verification of safeguards in GMP manufacturing.

Requirements

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.
• Coordinate 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.
• Ability 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.
• Must 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

• 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