Process Engineer
4 weeks ago
We are seeking a skilled and proactive Process Engineer to lead the process design and oversee engineering deliverables for drug substance manufacturing, with a strong focus on downstream processing. The Process Engineer will serve as the owner’s representative, working closely with vendors and reviewing all critical engineering documentation to ensure high standards and compliance.
Key Responsibilities:
- Process Design: Lead the design and optimization of manufacturing processes for drug substance production.
- P&ID Review: Prepare, review, and verify P&ID (Piping & Instrumentation Diagrams) to ensure accuracy and completeness.
- Vendor Coordination: Collaborate and coordinate with equipment vendors to align on specifications and technical requirements.
- Engineering Deliverables: Oversee and manage the timely delivery of engineering documentation, including process flow diagrams (PFDs), equipment specifications, and mass and energy balance calculations.
- Downstream Processing Expertise: Provide in-depth technical expertise on downstream processes, including chromatography, tangential flow filtration (TFF), and final filtration stages.
Qualifications:
- Education: Bachelor's or Master's degree in Chemical Engineering or Mechanical Engineering.
Technical Skills:
- Proficiency in mass and energy balance calculations.
- Strong background in creating, preparing, and reviewing PFDs and P&IDs.
- Expertise in equipment specification and selection for downstream processes.
- Thorough understanding of downstream process technologies such as chromatography, TFF, and final filtration.
- Familiarity with ASME BPE standards.
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