Amgen

Sr. Engineer

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 24, 2022
Ref
R-146962
Required Education
High School or equivalent
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Sr Engineer

Live

What you will do

Lets do this. Lets change the world. This engineering position supports manufacturing activities associated with Pilot plant equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with Amgens Commissioning and Qualification Process (CQP) to ensure that new GMP and non-GMP equipment is installed and maintained in a validated state. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and coordinate the operation and reliability of equipment. The engineer must work closely with Quality Assurance (QA) for GMP compliance. In addition, the engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and detail appropriate practices for characterization.

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

  • Be individually accountable for the verification work on key capital projects
  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assist in development and review of User Requirements Specifications (URS).
  • Suggest design modifications to address risks and design in quality and safety.
  • Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
  • Coordinate development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
  • Recommend, evaluate, and manage performance of contract resources
  • 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 carried out and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance and manufacturing activities
  • Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
  • Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
  • Conduct and document periodic equipment validation reviews

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
  • Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
  • Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
  • Participate in internal audits and assess in conjunction with QA.
  • Assist in developing and maintaining metrics

Win

What we expect of you

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

Basic Qualifications

Doctorate degree

Or

Masters degree & 3 years of engineering and/or manufacturing experience

Or

Bachelors degree & 5 years of engineering and/or manufacturing experience

Or

Associates degree & 10 years of engineering and/or manufacturing experience

Or

High school diploma / GED & 12 years of engineering and/or manufacturing experience

Preferred Qualifications / Skills / Experience
  • Bachelor's degree in engineering or other 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.)
  • Working 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
  • Understanding and awareness of industry/regulatory trends for verification/validation
  • Experience with combination product / medical device quality systems verification
  • Strong process equipment knowledge cell culture, fermentation, purification, filling, and packaging
  • Strong process automation knowledge understanding of automation infrastructure, current technologies, and automation project execution / verification.
  • Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
  • Demonstrated 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 culture that relies on collaboration for effective decision-making
  • Consistent track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)

Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com
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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.