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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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

Senior Engineer

Live

What you will do Let’s do this. Let’s change the world.

This project engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with Amgen’s Commissioning and Qualification Process (CQP) to ensure that new 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 supervise 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 document appropriate practices for characterization.

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

• Be individually accountable for the verification deliverables 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).
• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
• Recommend, evaluate, and lead performance of contract resources
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering and Quality Assurance during project planning, implementation, and closeout
• Ensure that validation protocols are performed 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. Cross 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 mentorship for manufacturing and maintenance
• Provide mentorship 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

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 individual with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree & 3 years of engineering and/or manufacturing experience OR
• Bachelor’s degree & 5 years of engineering and/or manufacturing experience OR
• Associate’s 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 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 implementation
• 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
• Proven strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a great teammate prepared to work in and adopt 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 improve 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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.

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