Amgen

Engineering Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 10, 2019
Ref
R-82905
Required Education
High School or equivalent
Position Type
Full time
The Engineering Manager will be joining Facilities & Engineering (F&E) group within Development Supply Chain (DSC) organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into the Director of Facilities & Engineering supporting clinical and commercial manufacturing at Amgen Thousand Oaks site.

Responsibilities include:
  • Lead the engineering team responsible for providing system ownership for Biopharmaceutical process equipment. Specifically - product assembly, label and packaging equipment, Cold storage facility/equipment (cold rooms, freezer rooms, stand up freezers etc) and supporting ancillary equipment (e.g. refrigeration skids), and distribution operations (e.g. powered industrial vehicles, forklifts etc).
  • Ensure safety of all personnel during plant operations and engineering activities.
  • Ensure that all staff are adequately trained and comply with all cGMP standards and procedures.
  • Maximize staff productivity and the efficient use of available resources
  • Maintain and develop key performance indicators, supervise, assess, and develop staff, and ensure that all targets and milestones are completed on time and on budget
  • Employ continuous improvement, innovation and transformative approaches to drive facility and equipment reliability, efficiencies in maintaining equipment lifecycle, agility in problem solving, and differentiation in transforming equipment supporting operations and supply.
  • Identify, support and/or lead implementation of engineering-based improvements or upgrades to the equipment and facility systems. This may include development of business case for improvement, plan project support staff for identification of design requirements leading to detailed design and supporting the construction, startup, and validation of equipment/facilities.
  • Support capital and department projects in defining strategies, identifying/leveraging resources and successful project execution.
  • Interface with a diverse Amgen internal network including DSC clients (plant and area managers), Facilities & Engineering leadership, Capital Projects, Corporate Engineering, Global Facilities and Operations, and Environmental Health and Safety, Process Development, and other Commercial Sites.
  • Ensure site readiness and compliance for internal audits, external agency audits, and partner audits
  • Coordinate business continuity. Perform administrative and oversight functions in approving proposals, planning and tracking to budgets.
  • Up to 10% domestic/international travel


Basic Qualifications

Doctorate degree
OR
Master's degree and 3 years of Engineering experience
OR
Bachelor's degree and 5 years of Engineering experience
OR
Associate's degree and 10 years of Engineering experience
OR
High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications
  • Bachelor's degree in Chemical or Mechanical or Industrial Engineering
  • 8+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment and 2+ years' experience leading teams/direct reports.
  • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
  • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as Refrigeration systems (walk in freezers, cold rooms, strand up freezers, LN2 transfer systems etc), HVAC systems, Utilities (chilled water, instrument air etc), High pressure steam boilers, Powered Industrial vehicles, Manual and Automation packaging and assembly systems, Bottling lines, Inspection systems.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
  • Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
  • Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
  • Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
  • Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
  • Work schedule flexibility as required to support escalations in a 24/7 operation


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.