Senior Process Engineer

Job Description

Job Description

We are looking for Senior Process Engineer for our client in Fremont, CA

Job Title : Senior Process Engineer

Job Location : Fremont, CA

Job Type : Contract

Job Description :

Pay Range : $51.14hr - $56.14hr

• The Senior Process Engineer will generally be responsible for processes and operations of medium to high complexity.
• Evaluate, transfer, and implement new processes into the Fremont GMP facility for the manufacturing of biopharmaceutical drug substances.
• This includes process transfers of internal 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 support deliverables with GMP / regulatory requirements.
• Responsible for providing 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 biopharmaceutical 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 experts and liaisons are responsible for the identification and implementation of at-scale manufacturing technology and improvements to effect positive change in 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, and 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 biopharmaceutical 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 routine GMP operations.
• Regulatory Filing.
• Project Management.
• Communication.
• Engineering.

Physical Requirements (Due to nature of job) :

• Must be able to gown into GMP facility, be able to occasionally stand for a long period.
• The candidate should be able to lift 50 pounds with assistance.

Education :

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

Company Description

visit our career site to see all open positions @ http : / / jobs.cynetsystems.com

Company Description

visit our career site to see all open positions @ http : / / jobs.cynetsystems.com