Sr Principal Eng, Process Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Athens, GA +1

Senior Principal Engineer, Process Engineering role at Johnson & Johnson focused on leading early design inputs and technical strategy for synthetic drug substance (API) manufacturing processes. Responsibilities include providing technical expertise in API unit operations, ensuring robust process design, driving adoption of digital and data-enabled solutions, and collaborating with cross-functional teams to enable reliable technical solutions and fast decision making. The role emphasizes cGMP standards, process safety, and robustness, while also fostering harmonization and best-practice exchange across the network.

What you'd actually do

  1. Lead the intake, scoping, prioritization, and resolution of synthetics drug substance (API) manufacturing technical requests across global sites
  2. Lead and influence early‑phase process design and act as domain expert for synthetics API processes, from technology and unit operation selection through scope definition and capital and schedule development
  3. Provide technical expertise in critical API unit operations and enabling technologies (e.g., hazardous chemistry, reactions, crystallization, filtration/centrifugation, drying, and particle engineering), with a strong emphasis on product quality, process safety, and robustness
  4. Ensure robust, fit‑for‑purpose process design while promoting standardization and platform approaches (e.g., common reactor trains, filtration/drying trains, solvent recovery concepts) where they make valuable contributions
  5. Ensure API cGMP standards are applied consistently and proactively assess emerging regulatory expectations and industry trends to keep API manufacturing solutions inspection‑ready and compliant

Skills

Required

  • Master's degree or equivalent experience in Engineering, Pharmaceutical Science
  • Expertise in synthetics API unit operations (chemical reaction, phase separations, distillation/solvent swap, crystallization/precipitation, filtration/centrifugation, drying, milling, blending)
  • Experience with process design and technical strategy for manufacturing processes
  • Knowledge of cGMP standards and regulatory expectations in API manufacturing
  • Experience with digital and data-enabled solutions for manufacturing (real-time monitoring, advanced process control, advanced data analytics, model and simulation, smart manufacturing)
  • Familiarity with industry experts and external networks (e.g., ISPE)

Nice to have

  • Experience in hazardous chemistry
  • Experience in particle engineering
  • Experience with reactors, filters/centrifuges, dryers, contained transfer, solvent recovery, CIP/SIP equipment

What the JD emphasized

  • cGMP standards
  • process safety
  • robustness