Amgen Senior Engineer - Manufacturing in Thousand Oaks, California
The Senior Engineer - Manufacturing 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. The Senior Engineer 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.
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.
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
Master's degree and 3 years of Engineering and/or Manufacturing experience
Bachelor's degree and 5 years of Engineering and/or Manufacturing experience
Associate's degree and 10 years of Engineering and/or Manufacturing experience
High school diploma / GED and 12 years of Engineering and/or Manufacturing 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
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, etc.)
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.
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.