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Aerotek - South San Francisco, CA

posted 2 months ago

Full-time - Entry Level
South San Francisco, CA
Administrative and Support Services

About the position

The Maintenance Engineer will perform routine maintenance and troubleshooting of building and process equipment in a Good Manufacturing Practice (GMP) environment within a cell therapy manufacturing facility. This role involves collaboration with cross-functional teams to ensure compliance with GMP standards, performing equipment calibrations, supporting validation testing, and responding to equipment failures to minimize downtime. The engineer will also execute preventative maintenance activities, support the installation of new equipment, and maintain accurate documentation of maintenance activities.

Responsibilities

  • Perform routine maintenance and troubleshooting of Building and other process equipment within a GMP environment.
  • Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations.
  • Perform equipment calibrations and support validation testing to meet quality and regulatory requirements.
  • Respond promptly to equipment failures and implement corrective actions to minimize downtime. Provide on-call support as required.
  • Execute preventative maintenance activities to ensure optimal functionality of manufacturing equipment.
  • Support the installation and qualification of new equipment, ensuring adherence to GMP guidelines.
  • Support facilities team in providing maintenance and repair in the GMP environment as needed.
  • Maintain accurate documentation of all maintenance activities and equipment logs in a CMMS.
  • Manage parts ordering and coordinate with equipment vendors and area owners to schedule maintenance activities.
  • Maintain tools and test equipment and ensuring they are properly calibrated and in good safe working condition.
  • Collaborate with manufacturing and quality control teams to address technical issues and optimize processes.
  • Support Quality Change Controls and CAPA investigations.
  • Stay updated on industry trends and advancements to contribute to continuous improvement initiatives.
  • Participate in training programs to enhance technical skills and knowledge.

Requirements

  • Associate degree or equivalent in engineering or a related field with 5 or more years' experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals.
  • Strong understanding of GMP regulations and quality standards.
  • Proficient in troubleshooting and repairing complex manufacturing equipment.
  • Ability to read and understand technical documents and engineering drawings.
  • Excellent organizational and documentation skills.
  • Ability to work collaboratively in a team-oriented environment.
  • Effective communication skills to interact with diverse stakeholders.
  • Detail-oriented with a commitment to maintaining high-quality standards.
  • Ability to lift and carry up to 50 lbs.

Nice-to-haves

  • Electrical skills
  • Troubleshooting skills
  • Mechanical skills
  • Hydraulics knowledge
  • HVAC knowledge
  • Plumbing knowledge
  • Preventive maintenance experience

Benefits

  • Weekly pay
  • Medical, dental & vision insurance
  • Life insurance
  • Health advocacy
  • Employee assistance programs
  • 401(k) plan
  • Employee discounts
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