Amgen Senior Engineer -Upstream Manufacturing in Thousand Oaks, California
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-Upstream Manufacturing
What you will do
Let’s do this. Let’s change the world. In this role the Senior Engineer at Amgen is responsible for developing and improving manufacturing processes, equipment, and products. They apply their engineering expertise to solve complex problems, lead technical projects, and collaborate with multi-functional teams to drive innovation and efficiency within the company.
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The senior 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 arguments and long term strategy.
The Senior Engineer role will provide direct engineering technical support as follows:
Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and objectives.
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
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).
Lead all aspects of 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 work performed with safety compliant practices and documented in accordance with cGMP good documentation
Review and approve the commissioning reports, maintenance practices and parts, and drive productivity improvement
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
Mentorship 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
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.
Master’s degree & 3 years of engineering and/or manufacturing experience
Bachelor’s degree & 5 years of engineering and/or manufacturing experience
Associate’s degree & 10 years of engineering and/or manufacturing experience
High school diploma / GED & 12 years of engineering and/or manufacturing experience
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
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
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.)
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 to $132048.
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.
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.