Biochemical Process Engineer

We have a contract opportunity for a Bipchemical Process Engineer in Fremont California. This position is approved for 1 year and could be extended.

Pay Rate: $55.00 to $58.50/Hr.

Job Description:

• Evaluates, transfers, and implements new processes into the Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.
• This includes process transfers of internal company products and external contract manufacturing business (CMB) of client products into the multi-product facility.
• Provide scientific and technological support during process transfers and launch.
• Provide interface between at-scale manufacturing and the customer within a cross-functional project organization and supports deliverables with regulatory requirements.
• 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.
• Liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to GMP manufacturing operations.
• 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.
• 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.
• 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:

1. Requires the individual to be able to independently plan, execute and deliver with occasional guidance from their leadership.
2. Experience working in cross-functional teams in a dynamic, high-pressure environment.
3. Ability to organize and multi-task in a fast-paced environment.
4. Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.
5. Experience with upstream and/or downstream bio-pharmaceutical manufacturing.
6. Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.

Education and Experience: 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.

Additional Details:

• Strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.
• Competency with MS Office Programs.
• Flexible to support a 24/7 GMP production facility.
• Hybrid remote/on-site working environment.
• Able to gown into GMP facility, occasionally stand for a long period of time and lift 50 lbs.

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.