Pay: $56.14/Hour

Description:

The Sr. Process Engineer will generally be responsible for processes and operations of medium to high complexity.

Evaluates, transfers, and implements new processes into the GMP facility for the manufacturing of biopharmaceutical drug substance. This includes process transfers of internal products and external contract manufacturing business (CMB) of client products into the multi-product facility.

Provide technical interface between at-scale manufacturing and the customer within a cross-functional project organization and supports deliverables with GMP/regulatory requirements.

Responsible to provide direction, strategy, technical leadership, coaching of junior group members, and support for process troubleshooting, process/tech transfers and continuous improvement efforts for a large-scale bio-pharmaceutical manufacturing plant.

Technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, inclusive of cell culture medium preparation, cell thaw, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest with centrifuge and/or filtration, liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation, filling, and freezing.

Technical expert and liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to our GMP manufacturing operations.

Independently or collaboratively plan and execute supporting activities, serving as an at-scale technical process SME, working with cross-functional teams and external clients to meet project timelines, quality requirements and to identify/mitigate risks.

Independently or collaboratively leads evaluating process requirements/facility-fit assessments for medium to high complexity projects including identification of materials/quantities and ensuring that processes are consistent with standard manufacturing practices, policies, and regulatory requirements in the large-scale GMP manufacturing facility.

Skills:

Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.

Experience with upstream and/or downstream bio-pharmaceutical manufacturing.

Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.

Experience with technical writing and BLA filing.

Must have a strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.

Physical Requirements:

Must be able to gown into GMP facility, be able to occasionally stand for a long period of time and able to lift 50 lbs.

Education:

Bachelor's Degree in Biochemical Engineering (or related field) with 6+ years of professional experience or, 10+ years demonstrating equivalent technical/design experience in large scale bio-pharmaceutical manufacturing.