Process Engineering Manager
The candidate will be responsible for the proper operation of the process equipment and facility supporting the CSO oral solid dosage manufacturing operation. Responsibilities include:
- Generating user requirement specifications as well as writing and executing factory acceptance test protocols, site acceptance test protocols, and equipment qualification protocols for oral solid dosage processing equipment.
- Oversees equipment qualification, the process equipment preventive maintenance program and instrument calibrations.
- Responsible for contributing to and leading quality investigations, change controls and generation of SOPs.
- The person in this role is considered the subject matter expert for equipment operation and maintenance and will be responsible for training staff on equipment operation.
- In addition, this role represents the first line of equipment troubleshooting.
- Bachelor's Degree in Engineering or relevant science field with a minimum of ten years of experience working with oral solid dosage process equipment.
- Candidates must be well versed in equipment project engineering work from initial specification development to installation and turnover to operations in a cGMP environment.
- The candidate should have the ability to read equipment and construction drawings (i.e. P&IDs, layout drawings, electrical drawings, etc.).
- Experience should include factory site acceptance testing, development and application of project specifications, startup and qualification.
- A background in automation technology as it relates to process equipment would be beneficial. Familiarity with Maximo and Trackwise is a plus.
- The successful candidate will have good oral and written communications skills.