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Genentech Sr Mfg Tech Specialist, Vendor Mgmt in South San Francisco, California,

Sr Mfg Tech Specialist, Vendor Mgmt

South San Francisco, California

Job ID: 202102-102898 (http://jobs.gene.com/202102-102898)

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Return to Search Results (https://www.gene.com/careers/find-a-job) The Position

The SSF Drug Product Manufacturing department is looking for a Manufacturing Technical Specialist to oversee the cleaning and sanitation program for GMP areas across the South San Francisco Production (SSFP) Site.

This position will manage the relationships between Genentech Site Services, SSFP, and Janitorial Services for the cleaning and sanitization of GMP areas in SSFP. Furthermore, the Manufacturing Technical Specialist will ensure the cleaning of the facility is performed in compliance with cGMP’s, OSHA, environmental, labor and other governmental laws and regulations while following appropriate documentation and quality systems at Genentech’s South San Francisco Production Site.

Responsibilities

  • Act as a single point of contact for SSFP GMP Operations with Janitorial Services

  • Work collaboratively with Manufacturing, Quality, Site Services, Janitorial Services, Facilities, and SHE to ensure

  • that appropriate cleaning programs have been established for all SSFP GMP areas

  • Partner with Site Services and Janitorial Services to ensure appropriate resources are allocated to support GMP cleanings

  • Responsible for identifying and implementing improvements for cleaning and sanitization of SSFP GMP areas including aseptic cleaning

  • Oversee GMP cleaning and sanitization staff training program and qualifications

  • Review and approve GMP cleaning related documentation in SSFP

  • Ensure that all GMP cleaning operations are performed with 100% compliance to documentation cGMP standards

  • Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations

  • Evaluate data and provide input to Site Services and Janitorial Services on cleaning staff performance and/or problem areas

  • Manage and resolve technical and compliance issues and investigations with Manufacturing, Quality, Maintenance, and SHE

  • Manage project teams to troubleshoot and proactively minimize potential for microbial contamination in the manufacturing clean rooms

  • Partner with Environmental Quality Assurance (EQA) to investigate all microbiological control failures and perform microbiological assessments of potential and actual adverse trends associated with cleaning and sanitization of GMP areas in SSFP

  • Oversee prompt closure of Adverse Trends through corrective action implementation associated with cleaning of GMP areas in SSFP

  • Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross-functional groups to identify and implement solutions

  • Represent the SSFP GMP Areas in reviewing and approving production related documentation requiring approvals such as: process validation protocols, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and production schedules

Qualifications

  • Bachelor’s degree in Microbiology, Life Science, or applicable Engineering plus

  • 5+ years experience with similar and relevant experience

  • Thorough understanding of Aseptic Techniques/Processes

  • Possess thorough knowledge and understanding of cGMPs

  • Thorough working knowledge of safe work practices in a manufacturing environment

  • Strong interpersonal skills

  • Experience with the Trackwise system and ownership responsibilities for Discrepancy Management, Corrective

  • And Preventative Actions, and Change Control

  • Demonstrated ability to build and maintain deep and productive partner relationships with a wide range of

  • stakeholders including members of senior management

  • Experience in ambiguous and rapidly changing business environments

  • Proven exceptional communication skills including: delivering presentations, preparing technical reports, and

  • revisions of technical documentation and procedures

  • Must be detailed oriented and demonstrate good record keeping

  • Experience with vendor contract oversight, Service Level Agreements, and negotiations

  • Working knowledge of SAP, Excel, and Discrepancy Management Systems

Work Environment, Physical Demands, Safety Considerations:

  • Be able to work flexible hours by supporting a 24/7 operation

  • Be able to work extensive hours while standing, sitting, or bending as necessary

  • Working with/around various chemicals (i.e. acids and bases), solvents, pressurized systems, compressed

  • gases, and biological materials (Recombinant DNA)

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Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

The next step is yours. To apply today, click on the "Apply for this job" 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.

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