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Amgen

Makes biotech medicines for serious illnesses

Director Engineering

Engineering LeadershipConfirmed live in the last 24 hours
Full-timeNew Albany, OH, USAIn-person

About the Job

Requirements

  • A doctorate degree and 4 years of manufacturing, packaging, or quality experience in pharmaceutical, medical device, or biotechnology companies; or a master's degree and 8 years of such experience; or a bachelor's degree and 10 years of such experience.
  • At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing the allocation of resources; this experience may run concurrently with the required technical experience.
  • Typically, 12+ years of relevant work experience, including 8+ years in an operations or manufacturing environment, preferred.
  • Typically, 10+ years of experience in regulated environments such as FDA/cGMP, OSHA, or EPA, preferred.
  • Experience leading an engineering department in a regulated GMP environment.
  • Knowledge of GMP manufacturing equipment and its design and operational aspects.
  • Organizational and administrative leadership skills.
  • Ability to work and influence locally and across the organization.
  • Ability to work in a highly dynamic organization with a demanding environment.
  • Verbal and written communication skills and ability to work cooperatively with cross-functional teams.
  • Team motivation, leadership, mentoring, and staff development skills.
  • Understanding of regulatory trends in the industry and direct experience with FDA or an equivalent regulatory body.
  • Ability to manage multiple resource demands and prioritization, assess project effectiveness and efficiency, and manage demand.
  • Ability to motivate staff, establish and communicate visions and missions, delegate, and manage the work of others.
  • Creativity, foresight, and mature judgment in anticipating and solving problems by translating data into actionable solutions.

Responsibilities

  • Provide leadership, strategy, and tactical direction for engineering and maintenance teams supporting assembly and packaging lines in 24/7 operations.
  • Ensure the safety of personnel during plant operations and engineering activities.
  • Ensure staff are adequately trained and comply with all GMP standards and procedures.
  • Maximize staff productivity and efficient use of available resources.
  • Maintain and improve plant capability and equipment reliability in partnership with plant leadership and other technical staff.
  • Leverage resources to support ongoing department capital project investment.
  • Identify potential improvement areas, conduct analyses, recommend solutions, sponsor improvement projects, and implement them as required.
  • Maintain and develop key performance indicators; supervise, assess, and develop staff; and ensure targets and milestones are completed on time and on budget.
  • Interface with internal stakeholders including plant and area directors, front-line managers, Facilities & Engineering leadership, Engineering and Automation, Engineering Technical Authority, Technology, Global Capital Project Management, Environmental Health and Safety, and Process Development.
  • Oversee a safe and compliant workforce at a highly utilized commercial operations site.
  • Provide day-to-day, small-project, and plant shutdown support.
  • Work with diverse clients, technologies, and integrated systems in product development within a GMP and highly regulated setting.
  • Manage partners and drive new business processes to ensure continuous and sustained improvements.
  • Ensure readiness and compliance for internal audits, external agency audits, and partner visits.
  • Present engineering plans, progress, and status updates to project stakeholders.
  • Review and approve proposed engineering designs, equipment improvements, and changes.
  • Approve proposals and expenditures as part of administrative and oversight functions.
  • Participate in developing department expenditure requests and partner with project teams to define engineering solutions that include long-term equipment performance.
  • Troubleshoot effectively and respond promptly to reduce downtime.
  • Drive robust equipment reliability.

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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