Maintenance Technician - South San Francisco, CA | Biospace
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Maintenance Technician

AbbVie Stemcentrx

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Location:
South San Francisco, CA
Posted Date:
5/26/2017
Position Type:
Full time
Job Code:
1703151
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

As a member of the Facilities Operations Team, the Maintenance Technician will be responsible for the equipment and facilities upkeep in support of the GMP Manufacturing, Quality Control, and GLP Bioanalytical teams, otherwise known as GxP. The successful applicant will have the following responsibilities and qualifications:

Key Responsibilities Include:


  • Coordinate routine and non-routine maintenance for all GxP equipment and building infrastructure to ensure operation as required for production runs and associated activities

  • Manage master schedule for all GxP maintenance activities, including equipment lifecycles and the planning/execution of shutdown activities

  • Support equipment sourcing, procurement, and installation, including participation in acceptance tests

  • Coordinate equipment qualifications (design, installation, operation, and performance), including review and approval of qualification protocols before and after execution

  • Manage the GxP facility monitoring system, responding to alarm notifications and coordinating new installations as well as annual re-certifications of existing inputs. SME for both BMS and FMS including review of monthly FMS reports.

  • Oversee external contractors and other visitors performing maintenance services on-site, providing relevant training as needed

  • Evaluate and enable in-house calibration functionality. Work with operations team to set up an onsite metrology group.

  • Review, file and maintain generated documentation for calibrations, qualifications, PMs and repairs

  • Follow GMP guidelines to work within change control systems to initiate engineering changes, deviations, and CAPAs. Lead investigations, impact assessments, executions, and resolutions.

  • Author new SOP’s, revise current SOP’s, complete all necessary documentation related to Engineering Change Requests, Out of Tolerance investigations, deviations and CAPA’s

  • Support the implementation of asset management software and procedures to move to electronic documentation of PM's, job plans and calibrations

  • Participate in contract negotiations for services related to GxP facility maintenance

  • Ensure compliance of facility and equipment in accordance with regulatory GxP guidelines as well as local code and safety requirements. Lead or participate in risk assessments associated with facility and equipment operations/maintenance.

  • Support other functions as needed including warehousing, materials management, GxP operations, and general facilities operations
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Requirements


Basic:


  • A.S./B.S. degree or equivalent with relevant industry experience, technical knowledge in facilities and asset management or maintenance

  • Training and experience in current Good Manufacturing Practices (GMP)

  • Experience with large-scale GMP manufacturing equipment preferred

  • Excellent organization and communication skills in a fast-paced environment

  • High level of self-motivation, attention to detail, and accuracy in work required

  • Ability to work under pressure and against tight timelines

  • Ability to work as part of a team and work independently with minimal supervision

  • Strong commitment to working safely, including ability to safely lift 30 lbs

  • Ability to work off-shift and extended hours as necessary

  • Mechanical aptitude and computer systems skills

  • Experience with Calibration and Maintenance Management Software (i.e. Maximo) preferred