Process Engineer – Pharmaceutical Manufacturing
益科德(上海)有限公司 · Shanghai
Job description
About the role
The Process Engineer will join multidisciplinary engineering teams to design and deliver aseptic and biotech facilities focused on insulin manufacturing. You will be involved from feasibility studies through detailed design, construction support and validation activities.
Key responsibilities
- Design upstream and downstream insulin processing units, including media, buffer, inoculum, fermentation, centrifugation, harvest and purification steps.
- Prepare feasibility studies, conceptual, basic and detailed designs, work packages and equipment specifications.
- Create layouts, block flow diagrams (BFD), process flow diagrams (PFD), piping and instrumentation diagrams (PID) and mass‑balance calculations.
- Perform hydraulic, heat‑load and utilities calculations, production capacity planning and scheduling.
- Coordinate with clients, vendors and contractors to develop datasheets, specifications and equipment packages.
- Support field construction, review submittals, conduct site walks and assist with commissioning and qualification (C&Q).
- Ensure compliance with GMP, safety and environmental requirements and prepare validation protocols (DQ/IQ/OQ).
Required profile
- Bachelor’s degree in Chemical Engineering, Chemistry or Biomedical Engineering.
- Minimum 3 years of engineering experience in the pharmaceutical industry.
- Proven experience with CAD, Revit, Plant 3D or PDMS for layout and diagram creation.
- Hands‑on experience in heat‑load, hydraulic and mass‑balance calculations.
- Familiarity with GMP requirements for insulin production.
Required skills
- CAD, Revit, Plant 3D, PDMS
- Layout development, PFD and PID creation
- Equipment specification and datasheet preparation
- Heat‑load, hydraulic and mass‑balance calculations
- Production scheduling and capacity planning
- GMP compliance and validation protocol preparation
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Published 1 month ago
Expires 4 days from now
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益科德(上海)有限公司
Shanghai