Amgen

Sr. Engineer - Drug Substance

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 21, 2019
Ref
R-71719
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Senior Engineer supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The Senior 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. Also works in partnership with the Maintenance, Project Management, Engineering Technical Lead, and Manufacturing to develop and oversee the operation and reliability of equipment. The Senior Engineer will work closely with Quality Assurance (QA) for GMP compliance and providing broad operational support to the manufacturing floor Scientific, technical interactions with partner organizations such as Process Development (PD) and Clinical Process Engineering (CPE). Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level. May support Manufacturing in troubleshooting Non-Conformance events, conducting problem solving and RCAs, owning class 2/3 NCs, and works with Quality, F&E, EH&S, PD, CPE etc. to develop and own CAPAs to prevent recurrence. May collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings. Serves as technical expert to lead or participate in projects to introduce new products and/or advanced technologies into the plant. In addition, the Senior Engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The Senior 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.

Responsibilities:
  • 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 manage 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, execution, and closeout
  • Ensure that validation protocols are executed 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
  • Conduct and document periodic equipment validation reviews

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Engineering and/or Manufacturing experience

OR

Bachelor's degree and 5 years of Engineering and/or Manufacturing experience

OR

Associate's degree and 10 years of Engineering and/or Manufacturing experience

OR

High school diploma / GED and 12 years of Engineering and/or Manufacturing experience

Preferred Qualifications
  • Bachelor's degree in engineering or other life 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
  • Experience in developing SOPs and delivering training
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
  • Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.
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.

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