HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Engineer
What you will do
Let’s do this! Let’s change the world!
Amgen is seeking a Senior Plant Engineer at its main headquarters in Thousand Oaks, CA to join the Manufacturing and Clinical Supply (MCS) Facilities and Engineering (F&E) organization. This position will work with the Engineering Manager and will provide engineering support for the Drug Substance facilities.
Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, identifying spare parts, job plan development and supporting engineering runs.
Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations
Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and s.
Use tools and techniques of continuous improvement wherever possible. Establish equipment monitoring parameters and control limits. Routinely provide updates on metrics. Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving. Change over reduction projects. Failure trending
Up to 10% domestic travel
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these 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 Engineering
6+ years’ of relevant work experience with 5+ years’ experience in Biopharmaceutical operations/manufacturing environment
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 cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
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
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $111,913 – $132,048.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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 cancers, 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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