Mfg. Technical Specialist II/Engineer I, Downstream Pilot Plant

Oceanside
California, United States of America


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The Position

Job Responsibilities

Summary

Responsible for supporting operations in the Oceanside Pilot Plant and Science and Engineering Purification/Analytical Lab.  Deliverables include but are not limited to: HPLC-based analytics, rapid bioburden/endotoxin, lab scale and pilot scale chromatography, UFDF operations, buffer prep, column packing, equipment maintenance and preparation of technical reports.  May commission new equipment, troubleshoot equipment and systems, develop new equipment requirements and operating parameters, and provide factory and site acceptance testing.  Provide scientific and technical support to GMP Manufacturing Operations in a multi-product, large scale, automated biopharmaceutical facility.  Support process validation through large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.

Job Responsibilities

  • Will contribute to the daily operations in the Oceanside Process Engineering (PE) pilot plant and/or analytical laboratory
  • Assist with the tech transfer of new products to Oceanside
  • Implement new purification processes and analytical methods into PE pilot plant and analytical lab
  • Perform pilot-scale studies as needed to support commissioning and optimization of the manufacturing scale and purification process tech transfers
  • Perform analysis of in-process intermediates and raw materials using HPLC, rapid bioburden and endotoxin, particle analysis, and small-scale protein purification and filtration for a variety of purposes, including investigations, process validation, process development/ improvement and routine testing.
  • Assist with the factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of S&E pilot plant equipment
  • Prepare area SOPs
  • Monitor small scale and large scale cell culture or purification processes to identify and resolve complex equipment and process issues
  • Contribute to process validation/characterization efforts, including but not limited to: large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.
  • Contribute to advances in technological capabilities
  • Provide technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment.
  • Support implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI)
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
  • May act as Subject Matter Expert for the purposes of training S&E personnel
  • Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing
  • Gathers data on campaign material consumption and creates detailed material requirements
  • Communicates changes for site logistics and planning functions to ensure correct inputs for

Job Requirements

  • Bachelor's or Master's degree in Engineering or Life Sciences.
  • 4-6 years experience in relevant field.
  • 2-4 years with Master
  • Proven knowledge and practical experience with core regulatory requirements
  • Demonstrated working knowledge of process control, manufacturing execution and enterprise resource planning systems.
  • Proven management, communication, interpersonal, organizational and project management skills.
  • Demonstrated ability to work as part of a multi-disciplinary team.
  • Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
  • Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.
  • Demonstrated technical proficiency, leadership, creativity, and strategic thinking.
  • Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.
  • Strong oral and written communication skills.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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