Mfg Technical Specialist II

Vacaville
California, United States of America


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The Position

  • Follow established safety and environmental guidelines and procedures for all work performed. 
    • Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
    • Fosters safe work practices
  • Comply with cGMP, SOP and manufacturing documentation.
  • Communicate effectively and professionally work in a team environment.
  • Working under limited supervision, take an idea or objective to produce a valuable business proposal and lead through implementation.
  • Routinely represent Manufacturing and lead cross-functional meetings or projects
  • Must work collaboratively and effectively to foster effective interdepartmental and cross-functional partnerships.
  • Clearly communicate with Manufacturing, Technology, Facilities, and Quality staff at various levels to drive efficient issue resolution and change implementation.
  • Apply discretion to independently address issues and resolve problems which may include primary responsibility for an assigned business/client group (i.e., CCP2 Downstream client).
  • Serve as a Manufacturing technical subject matter expert (SME) for risk assessments, procedural revisions, Tracking Action/CAPA planning and execution, inspection responses, and process and equipment changes.
  • Contribute to LPS implementation and sustainment by acting as a change agent and utilizing OE Tools
  • Collaborate with Technical Training and Training Program Coordinators in the Manufacturing Learning Group to develop training materials and align on training/documentation strategy and guiding principles.
  • Perform Change Owner responsibilities for Manufacturing supported CAPAs, technology transfer changes, shutdown activities, inspection responses, post marketing commitments, and other Manufacturing continuous improvements projects.
  • Manage and implement all Manufacturing controlled document changes by creating new and revising existing Standard Operating Procedures, Manufacturing Formulae, and Forms that support CCP1/2 operations.
  • Review all manufacturing revision requests and collaborate with technical experts and stakeholders to align on document revision prioritization, necessity, and improvement opportunities.
  • Act as a Manufacturing technical subject matter expert (SME) in the following business systems: Trackwise Change Management (TCM), condor portal, and condor FirstDoc.
  • Troubleshoot and direct the resolution of Manufacturing Quality System related issues by fostering effective interdepartmental and cross-functional partnerships.
  • Provide technical training to manufacturing operations staff regarding process, equipment, automation and operational changes.
  • Perform debug and testing of equipment and processes for campaign readiness changes and tech transfer process changes to ensure compliant execution of process improvements.
  • Provide technical Manufacturing support of projects with involvement throughout the project life cycle including project scope, option analysis, protocol generation, execution, and qualification. Assist engineers with design and implementation of larger projects.
  • Ensure a high degree of engrained safety, quality, cGMP compliance, reliability, and cost efficiency to portfolio projects by ensuring hazard/human error prevention and efficient Manufacturing user requirements are built-in during project design. 
  • Lead project teams to troubleshoot complex problems and support continuous process improvement. Facilitate root cause analysis (RCA), develop and implement change to improve performance with input form SMEs.

Job Requirements:

Education and Experience

?       AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering and at least three years experience in the pharmaceutical, biopharmaceutical industry, working in a cGMP manufacturing environment, or an equivalent combination of education and experience.

?       Or combination of education and related work experience.

 

Knowledge, Skills, and Abilities

?       Candidate must have an in-depth understanding of biochemical manufacturing process, strong analytical thinking and problem solving skills

?       Demonstrated track record of taking initiative, resolving a variety of complex technical problems, recommending and implementing process improvements.

?       Excellent verbal and written communication skills. Attention to detail and quality oriented

?       Familiarity with computer-based systems

?       Ability to read and understand engineering documents.

?       Ability to create and revise Standard Operating Procedures and Manufacturing Formula to enable repeatable, right-first-time results.

?       Proven ability to drive quality and productivity improvements through the use of LPS tools and methods.

?       Strong collaboration skills across multidisciplinary stakeholders required, with the ability to achieve value-added results in a dynamic business environment.

Work Environment/Physical Demands/Safety Considerations:

  • Must be able work weekends, off-shifts, and overtime as required.
  • No make-up or jewelry can be worn when working in the clean room environment.
  • Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems. 
  • Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.
  • Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
  • Handle and work with hazardous materials and chemicals per OSHA guidelines.
  • Usage of hearing protection and dust masks may be required.
  • Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems. 
  • Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
  • In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License.

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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