Job Title: Bioprocess Engineer
Job Overview:
The Bioprocess Engineer will provide technical process design support for bioprocess systems on new capital projects. This role is responsible for generating user requirement specifications, reviewing and approving design documentation, and ensuring compliance with safety and operational requirements.
Responsibilities:
* Develop user requirement specifications (URS) for assigned systems
* Review and approve basis of design (BOD) and detail design of assigned systems
* Ensure procurement packages meet equipment specifications
* Track and implement HAZOP action items into system design
* Participate in 30%, 60%, and 90% model reviews to ensure systems meet operational, safety, and ergonomic requirements
* Review and approve system lifecycle documentation
* Attend factory acceptance tests (FAT) and automation software bench FAT if required
* Supervise and execute site acceptance testing (SAT) and commissioning activities
* Generate FAT, SAT, and commissioning protocols for assigned equipment
* Ensure vendor document requirements meet company standards
* Build preventative maintenance tasks and spare parts lists on computerized maintenance management systems (CMMS)
Requirements:
* Requires a bachelor's degree in chemical, process, or mechanical engineering with 3-5 years of related experience
* Direct experience with biopharmaceutical process equipment is preferred, may substitute relevant experience for education
* Experience with design and commissioning within the biopharmaceutical sector is desirable
* Experience with DeltaV is also desirable