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Amgen

Makes biotech medicines for serious illnesses

Manager Process Maintenance

Equipment MaintenanceConfirmed live in the last 24 hours
Full-timeHolly Springs, NC, USAIn-person

About the Job

Requirements

  • High school diploma or GED and 12 years of maintenance and/or operations/manufacturing experience; or an associate’s degree and 10 years; or a bachelor’s degree and 5 years; or a master’s degree and 3 years; or a doctorate degree.
  • Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing resource allocation. Managerial experience may run concurrently with the required technical experience.

Responsibilities

  • Provide technical and administrative leadership to a group responsible for planning and scheduling adherence, troubleshooting, repairing, maintaining, and improving the reliability of GMP and non-GMP equipment at Amgen, North Carolina.
  • Establish team strategies, objectives, and goals; improve team performance; and consistently achieve key metrics and milestones.
  • Meet regularly with key clients to identify opportunities and establish the Maintenance Team’s strategic direction.
  • Establish annual team goals, track progress, and communicate progress to the GMP F&E leadership team.
  • Develop staff through annual Career Development Planning and serve as a role model.
  • Improve team performance through regular one-on-one meetings and the Maximizing Amgen’s Performance process, including coaching, mid-year and end-of-year reviews, compensation planning, and talent management planning.
  • Promote Operational Excellence and Safety through regular job-task walkthroughs with staff members.
  • Partner with maintenance managers, as a member of the extended leadership team, to improve Maintenance support.
  • Provide subject matter expertise to triage and resolve issues related to Maintenance process non-conformances.
  • Use knowledge of GMP F&E processes, mechanical and utility systems, and instrumentation to develop team capabilities in diagnosing and troubleshooting issues.
  • Manage lifecycle assessments and recommend replacements or upgrades to ensure high reliability.
  • Maintain awareness of relevant industry and regulatory trends for calibration, instrumentation, and maintenance.
  • Provide input for responses to regulatory inspections or internal audits relating to instrument calibrations or maintenance programs.
  • Manage staff resources and work schedules, including vacations and on-call rotations, to ensure adequate coverage and meet required preventive maintenance calibration dates.
  • Ensure staff maintain required training qualifications and are cross-trained to support multiple GMP functional areas as needed.
  • Coordinate resources to support capital projects and work activities during maintenance shutdowns.
  • Manage department budget and expenses.
  • Work may require second- or third-shift coverage.

Desired Qualifications

  • Bachelor’s degree in life science, a technical field, or an aligned field of study.
  • Six or more years of relevant work experience in an operations/manufacturing environment.
  • Three or more years of experience in regulated environments such as cGMP, OSHA, or EPA.
  • Managerial experience directly managing people and/or leadership experience leading teams.
  • Experience working with ATO GMP F&E clients and systems, including Bulk Manufacturing, Filling and Packaging, Supply Chain, Quality Labs, and Small Molecule Manufacturing.
  • In-depth technical knowledge of GMP equipment and instrumentation.
  • Experience supporting GMP capital project execution and verification activities.
  • Demonstrated leadership attributes as an individual contributor, such as leading initiatives or participating on network-level or continuous-improvement teams.
  • Demonstrated proficiency in process-improvement methodologies.
  • Strong background in GMP Maintenance, with leadership and written and verbal communication skills.
  • Ability to support multiple clients and prioritize resources against competing objectives.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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