API Process Safety & Thermal Hazards Engineer

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. We are seeking an Active Pharmaceutical Ingredient (API) Process Safety and Thermal Hazards Engineer to work on-site with a CDMO client in Petersburg, VA that is dedicated to building a secure, sustainable, and accessible supply of medication in the United States. The role in the API Process Safety Program involves strong emphasis on chemical process safety, reaction chemistry, and thermal hazard management.

This contract to direct hire opportunity offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as paid holidays and 401K plan.

KEY TASKS

(1) Build, implement, and continuously improve the Active Pharmaceutical Ingredient (API) Process Safety Management program in alignment with OSHA, EPA, and internal procedures

(2) Lead and manage process hazard analyses, including HAZOP, PHA, PFMEA, and PSSR; perform root cause analysis and track closure of all recommendations

(3) Supervise the application of process safety elements across project lifecycle stages, from development through commercialization

(4) Identify and mitigate hazards typical to API manufacturing; evaluate chemical reaction hazards, including exothermicity, thermal instability, runaway potential, and decomposition risks

(5) Design and oversee thermal hazard characterization studies including DSC, RC1 (reaction calorimetry), ARC, ARSST, VSP2

(6) Assess and manage risks associated with cryogenic reactions, air-sensitive chemistries, and pyrophoric materials

(7) Develop and support relief and vent system design (PSVs, rupture disks, vent sizing, scrubbers), and contribute to LOPA/SIL assessments

(8) Apply modeling tools (e.g., CHEETAH) and process simulation software (Aspen Plus, COMSOL, gPROMS) to evaluate reaction and relief scenarios

(9) Develop, analyze, and implement mathematical models to simulate chemical processes, including emergency and relief conditions as well as refine process safety predictions

(10) Utilize Process Analytical Technology (PAT) (IR, Raman) to enhance process understanding, safety, and robustness

(11) Ensure results are translated into safe operating limits, equipment design, interlocks, and procedures

(12) Provide technical leadership for process scale-up, from laboratory (mL to 72 L) to pilot and manufacturing scale (50–4000 gallon reactors)

(13) Manage, mentor, and coach team members on process safety principles and risk analysis techniques; drive implementation of corrective and preventive actions

(14) Collaborate cross-functionally with Tech Transfer, Manufacturing, Process Engineering, Quality & Regulatory, Maintenance, and EHS

REQUIREMENTS

(1) Minimum of bachelor’s degree in Chemical Engineering, Chemistry, or a closely related field.

(2) Experience in process safety, chemical engineering, or EHS in manufacturing (pharma/API or chemical processing).

(3) Hands-on experience with exothermic/reactive chemistry, overpressure protection, cryogenic/flammable systems, air-sensitive reagents, pyrophorics

(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) Strong analytical and problem-solving skills with the ability to collaborate in cross-functional teams.

(7) 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.