Duties:
The Sr. process engineer will generally be responsible for processes and operations of medium to high complexity.
Evaluates, transfers, and implements new processes into Boehringer s Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.
This includes process transfers of internal Boehringer products and external contract manufacturing business (CMB) of client products into the multi-product facility.
Demonstrate the expertise and drive to implement innovative solutions to complex problems using the best available technology.
Provide scientific and technological support during process transfers, launch, and initial supply.
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.
Independently or with support from management/Senior SME to author and maintain technical documentation for at-scale processes of higher complexity such as Process Descriptions, Bill of Materials, Campaign Performance Summaries and Presentations, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, technical sections of CMC dossiers, BLA Filing, etc.
Responsible for periodic process monitoring/trending and reporting for large-scale manufacturing processes inclusive of designing and developing data repositories and visualizations to monitor, analyze, evaluate, and report process data and trends.
Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or, continuous improvement of, at-scale manufacturing.
Skills:
Requires the individual to be able to independently plan, execute and deliver with occasional guidance from their leadership.
Experience working in cross-functional teams in a dynamic, high-pressure environment.
Ability to organize and multi-task in a fast-paced environment.
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.
To improve the overall efficiency and integrity of the routine GMP operations must have skills:
Regulatory Filing
Project Management
Communication
Engineering
Must have a strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.
Possess an excellent mechanical aptitude.
Competency with MS Office Programs.
Good communication skills.
Ability to work in a team setting and as an individual contributor.
Flexible to support a 24/7 GMP production facility.
Hybrid remote/on-site working environment.
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.
Required Skills:
MANUFACTURING PROCESSES
MIXING
ASEPTIC PROCESSING
PHARMACEUTICAL MANUFACTURING
CONTRACT MANUFACTURING
Additional Skills:
GMP
BIOPHARMACEUTICAL
LARGE-SCALE
PRODUCTION FACILITY
PROJECT MANAGEMENT
FILING
CELL CULTURE
MECHANICAL APTITUDE
FILTRATION
LIAISON
COACHING
DOCUMENTATION
MICROSOFT OFFICE
TECHNICAL LEADERSHIP
SUBJECT MATTER EXPERT
MS OFFICE
LIQUID CHROMATOGRAPHY
PACKING
PROCESS DATA
BIOCHEMICAL ENGINEERING
CMC
PROCESS ENGINEER
OPERATIONS
OUTSOURCED MANUFACTURING
