Kelly Government Solutions has a full-time direct hire opportunity to work on-site at Phlow Corp as a Process Safety Engineer (Pharma CDMO environment) on the Petersburg, VA campus.
HIGHLIGHTS
KEY TASKS
(1) Build the active pharmaceutical ingredient (API) manufacturing process safety program from the ground up for small-molecule API manufacturing
(2) Build, implement, and continually improve the Process Safety program in alignment with OSHA PSM, EPA requirements, and Phlow procedures.
(3) Responsible for the process safety activities associated with technology transfer, process design, and GMP startup
(4) Lead process safety assessments, Management of Change (MOC), and the implementation and verification of safeguards in GMP manufacturing
(5) Lead PFMEAs, PHAs, and PSSRs for new and existing API processes; translate outcomes into practical engineered and administrative controls for GMP operations.
(6) 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.
(7) Coordinate thermal hazard characterization (e.g., DSC/ARC/RC1) and ensure data are integrated into equipment design, operating limits, automation strategies, interlocks, and procedures.
(8) Develop and support relief and vent strategies (PSVs/rupture discs, vent sizing, scrubbers/containment) and contribute to LOPA/SIL evaluations and verification of assumptions.
(9) Own the process safety portion of the MOC process by evaluating risk impacts, defining required safeguards, and confirming PSI updates, training, and startup readiness.
(10) Define mechanical integrity expectations for critical protective systems and instrumented functions; work closely with Maintenance and Engineering to prioritize and validate testing.
(11) Develop and deliver training and coaching for employees and contractors on process safety and life safety requirements related to API manufacturing.
(12) Collaborate 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
(1) Bachelor’s degree in Chemical Engineering or a closely related scientific or engineering discipline.
(2) Minimum of seven (7) years of experience that includes process safety, chemical engineering, or EHS in a manufacturing capacity; pharma, drug substance, and/or chemical processing experience highly preferred
(3) Demonstrate practical experience with exothermic/reactive chemistry, overpressure protection, or cryogenic/flammable systems.
(4) Working knowledge of OSHA/EPA regulations and core PSM elements (PHA/HAZOP, LOPA/SIL concepts, MOC, PSSR, incident investigation).
(5) Proficiency with process safety tools and documentation (PSI, risk assessments, action tracking).
(6) Ability to work in GMP manufacturing suites, technical areas, and utilities with potential exposure to chemical materials, elevated noise, and high awareness for personnel and equipment safety
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