Sr Principal Eng - Process Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Geel, Antwerp, Belgium

This role is for a Senior Principal Engineer in Process Engineering focused on synthetic drug substance (API) manufacturing within strategic capital projects and technology platforms. The engineer will provide technical expertise in API unit operations, ensure cGMP compliance, drive adoption of digital solutions for manufacturing, and collaborate with cross-functional teams and external partners. The role emphasizes process quality, safety, robustness, and standardization.

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 Sciences, or a related field
  • Extensive experience in synthetic drug substance (API) manufacturing process engineering
  • Expertise in API unit operations (chemical reaction, phase separations, distillation/solvent swap, crystallization/precipitation, filtration/centrifugation, drying, milling, blending)
  • Experience with technical strategy for capital projects and technology platforms
  • 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, data analytics, model/simulation)
  • Strong collaboration and influencing skills across multi-functional teams
  • Experience with process safety and product quality principles

Nice to have

  • Experience with hazardous chemistry
  • Knowledge of particle engineering
  • Familiarity with external manufacturing organizations (CMOs)
  • Connections with industry experts and external networks (e.g., ISPE)

What the JD emphasized

  • cGMP standards
  • process safety
  • product quality
  • robustness