Process Engineer II
About The Position
This role requires close collaboration with multi-disciplinary project/technical teams as we work together to define the future of biotherapeutics and embrace the challenge of innovation. Under direct/moderate supervision, job responsibilities encompass the transfer of novel purification processes from model to manufacturing scale. Process engineers will work closely with scientists and engineers to develop manufacturing processes for novel biotherapeutics. The PE II will then execute upstream and/or downstream manufacturing operations they had a hand in building. The role will work with disposable based manufacturing equipment and be involved in upstream manufacturing operations including performing aseptic operations, shake flask cell expansion process, bioreactor operations and media preparation; and downstream manufacturing operations including continuous protein capture, chromatography polishing steps, and drug formulation and fill. The staff member may also participate in technology transfer, troubleshooting, GMP documentation revision and deviation investigations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
Requirements
- Bachelor’s degree in biological science or engineering
- 3-5 years of relevant experience
- Strong focus on quality and attention to detail
- Effective task/time management organizational skills
- Capacity to develop solutions to technical issues of moderate scope
- Ability to organize, analyze/interpret, and effectively communicate individual results
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills
- Excellent oral and written communication skills
Nice To Haves
- Knowledge of cGMP requirements to ensure compliance
- Understanding of equipment, operations, and engineering principles used to manufacture biotherapeutics
- Experience in cell culture principles and aseptic technique
- Experience in purification principles and operations
- Experience with disposable-based processing equipment is a plus
- Experience in technology and/or process transfer for early-stage clinical manufacturing
- Ability to solve technical problems of moderate scope
Responsibilities
- Transfer of novel purification processes from model to manufacturing scale.
- Develop manufacturing processes for novel biotherapeutics.
- Execute upstream and/or downstream manufacturing operations.
- Work with disposable based manufacturing equipment.
- Perform upstream manufacturing operations including aseptic operations, shake flask cell expansion process, bioreactor operations and media preparation.
- Perform downstream manufacturing operations including continuous protein capture, chromatography polishing steps, and drug formulation and fill.
- Participate in technology transfer, troubleshooting, GMP documentation revision and deviation investigations.
- Comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
Benefits
- Discretionary annual bonus
- Comprehensive benefits to include Medical, Dental and Vision
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Flexible work
- Generous paid time off and paid holiday
- Wellness benefits
- Transportation benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
