Chemical Process Engineer II (Direct Hire)
Job Requisition: 6390
Description for Chemical Process Engineer II:
The Chemical Process Engineer II will create and implement manufacturing process designs in compliance with cGMP regulations. Will define and create new procedures for documenting or qualifying equipment and processes which can effectively be transitioned in to manufacturing and production. The successful candidate will be familiar with manufacturing within a cGMP regulated environment, knowledge of Clean-In- Place and have in-depth engineering knowledge.
Responsibilities for Chemical Process Engineer II:
- Specify new equipment, implement solutions to complex requirements and create fixtures to support manufacturing processes in cGMP environment.
- Create processes that bridge R&D and manufacturing, and support transfer into manufacturing
- Investigate, recommend and assist with design implementation and manufacturing process decisions to maximize productivity.
- Collaborate internally and externally (i.e. suppliers) to design, purchase and build equipment and processes.
- Anticipate and mitigate risk points.
- Interpret detailed engineering drawings.
- Introduce and train manufacturing on new processes and manufacturing capability.
- Continuously adapt to an ever-changing regulatory environment, making adjustments to work plans accordingly.
Requirements for Chemical Process Engineer II:
- Bachelor’s degree in Chemical Engineering or other Engineering Discipline
- 3+ years of experience in a cGMP manufacturing environment; Medical device, pharmaceutical preferred
- Knowledge of full Product Development Life Cycle ranging from product specification and concept development to product release
- Experience with Clean in Place required
- Experience transferring products/processes into manufacturing
- Experience validating products and processes
- Knowledge and skill in operation of scientific equipment
- Knowledge of FDA regulations in medical device/pharmaceutical environments preferred
- Ability to travel up to 20% of the time.