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Bio-Process Engineer

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 28, 2023

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.

Bio-Process Engineer

Live

What you will do

Lets do this. Lets change the world. In this role support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and lead all aspects of the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

The Engineer role will provide direct engineering technical support as follows:

  • Model leadership behaviors and positive values to create a positive working environment.
  • Be individually accountable for the consistent equipment performance
  • Be accountable for assigned results on key capital projects
  • Suggest design modifications to address risks and design in quality and safety.
  • Provide oversight for verification work developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices.
  • Ensure safety during commissioning, validation, maintenance, and manufacturing activities

Related Activities:
  • Participate or lead, when required, multidisciplinary site teams, e.g. Multi-functional Team, Root Cause Analysis lead.
  • 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.
  • Provide ad hoc technical support and guidance for manufacturing and maintenance
  • Mentor and guidance to project teams and engineers using risk-based approaches
  • Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
  • Participate in internal audits and assess in conjunction with quality assurance
  • Assist in developing and maintaining business metric performance

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

Basic Qualifications:

Masters degree

OR

Bachelors degree & 2 years of engineering and/or manufacturing experience

Or

Associates degree & 6 years of engineering and/or manufacturing experience

Or

High school diploma / GED & 8 years of engineering and/or manufacturing experience

Preferred Qualifications:
  • Bachelor's degree in engineering or another science-related field
  • 7+ years of relevant work experience with 5+ years experience in operations/manufacturing environment
  • Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
  • Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
  • Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
  • Experience with combination product / medical device quality systems verification
  • Process equipment knowledge basic principles of cell culture, fermentation, purification, filling
  • Process automation knowledge fundamental understanding of automation infrastructure
  • Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
  • Strong communication and technical writing skills
  • Strengths in facilitation and collaboration / networking
  • Experience in developing SOPs and delivering training
  • Individual must be a standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making
  • Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)

ThriveWhat 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.

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.

careers.amgen.com

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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