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Sr Engineer

1 month ago

Thousand Oaks, United States BioSpace, Inc. Full time
Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Engineer

Live

What you will do

Lets do this Lets change the world In this dynamic role you will provide engineering support for the Biopharmaceutical Production facilities. Responsibilities include:
  • Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of reason 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.
  • Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
  • Be individually accountable for the verification deliverables on key capital projects
  • Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Ensure safety during commissioning, validation, maintenance and manufacturing activities
  • Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
  • Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout
  • Ensure vital commissioning and qualification of systems is completed and interact with inspectors
  • Monitor systems to identify performance risks and implement risk reduction strategies
  • Providing problem solving 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, and supporting engineering runs
  • Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations
  • Provide ad hoc technical support and guidance for manufacturing and maintenance
  • Up to 10% domestic travel
Win
What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Engineering professional we seek is a dedicated partner with these qualifications.
Basic Qualifications:
Doctorate degree
Or
Masters degree and 2 years of Engineering experience
Or
Bachelors degree and 4 years of Engineering experience
Or
Associates degree and 8 years of Engineering experience
Or
High school diploma / GED and 10 years of Engineering experience
Preferred Qualifications:
  • Bachelors degree in Chemical or other Engineering fields
  • 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 and/or non-GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
  • Understanding of safety requirements working in a Biopharmaceutical Production facility.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
  • Phenomenal teammate prepared to work in and adopt 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
Thrive
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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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
Apply now
for a career that defies imagination

Objects in your future are closer than they appear. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your 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.