Production Maintenance Manager

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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Job Description
 

Seeking a GMP (Good Manufacturing Practices) Manager that will guide a group of seasoned mechanics (Approximately 18) that is responsible for the GMP Equipment (Aseptic Fill Line, Isolator, Terminal Sterilizer, Small Flex Fill Line, Robots, Parts Washers, Autoclaves, Temperature Control Units etc.)  from a facilities perspective of a 400,000 square foot manufacturing facility.  This position requires a person to adhere to Gilead’s Core Values:  Integrity (Doing What’s Right), Inclusion (Encouraging Diversity), Teamwork (Working Together), Excellence (Being Your Best) and Accountability (Taking personal Responsibility. 

Qualification Requirements:

• Degree or equivalent with at least 8 to 10 years of relevant experience in maintenance/equipment supervisory role in a highly regulated manufacturing environment (Pharmaceuticals Industry Desirable).

• Prior experience in a GMP regulated facility.

• Deep understanding of GMP facility equipment (Lyo’s, Aseptic Fill Lines, Parts Washers, Autoclaves, Isolators, Spray Dryers, Homogenizers etc.)

• knowledge and criticality of it as it relates to pharmaceutical environment.

• 6 Sigma Green Belt Certification. Able to work flexible hours.

• Proficient in Microsoft Office Products and able to report on KPI’s.

• Knowledgeable with Maximo is a plus.

• This position requires the manager to assist with maintenance work.

Job Duties:

• Coordinates the work with GMP mechanics in completion of maintenance work orders. 

• Provide guidance to GMP mechanics with complex tasks. 

• Maintain inventory of parts and supplies for GMP Facilities repairs.  Gilead’s MRO Group is responsible for the ordering of parts, it’s this position that is responsible to make sure we have the proper quantity ordered and on hand.

• Coordinate the OEM visits for equipment maintenance and troubleshooting activities.  Effective cross functional leader is required when troubleshooting or implementing specific projects.

• Be able to respond to compliance problems and complaints received and participate in investigations.

• Have extensive root cause analysis background and assist the Reliability Group in these efforts.  Must coordinate resources for troubleshooting equipment repairs. This will be cross functional coordination.

• Manage the SOP’s that relate to the GMP Facilities Group and keep them current with regulatory requirements.

• Review job plans to be certain they are accurate.  If not, assist Reliability Group in making them correct and effective.

• Prepare job estimates for special projects