Position: 2 openings - BioProcess Engineer/Sr BPE
(1 - Cell Expansion / 1 - Downstream)
Must have worked in a manufacturing environment.
The BioProcess Engineer is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.
Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence.
The BioProcess Engineer will be responsible for driving the process, planning ahead to avoid delays, good documentation practices, and providing leadership for the team.
- Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs
- Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed
- Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
- Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process
- Partner with Quality to ensure a quality and compliant manufacturing environment
- Assist the technical operations team to resolve any issues related to production
Required Education and Experience
- Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field or a minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with:
- Working knowledge of FDA regulations and GMP systems
- Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence
- Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing) - Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.