Senior Process Engineer
3 weeks ago
Key Responsibilities:
The Senior Engineer will work independently and productively within a team-based organization to actively address complex GMP manufacturing issues. This individual will be responsible for analyzing process technologies in support of new project proposals and taking responsibility for the technical transfer into the manufacturing group for Clinical and/or Commercial.
Key Requirements:
- Apply scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client-specified manufacturing processes for biologics, including viral-based products and vaccines.
- Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
- Research and recommend single-use process equipment of appropriate scale and quality for the cGMP execution of client-specified manufacturing processes.
- Prepare user requirements, vendor quotes, and purchasing of equipment, as well as supporting capital projects by providing technical expertise.
- Oversee and lead small complex engineering projects.
- Provide technical information for the preparation of change controls, protocols, and new user training for the process equipment.
- Review process requirements for GMP manufacturing through process specifications and batch records.
- Identify raw materials and consumables of appropriate quality for the cGMP execution of client-specified manufacturing processes.
- Respond to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.
- Use key and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications.
Technical Expertise:
- Support single-use equipment and systems, including fermentation and cell culture reactors, GE AKTA chromatography systems, and tangential flow filtration systems.
- Work in cGMP environments in relation to biologics and vaccine manufacturing.
- Process development or manufacturing experience with clinical scale projects.
- Single-use manufacturing equipment and materials.
- Understanding and experience in aseptic techniques.
- Document writing, including protocols, batch records, and SOPs.
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