Senior Engineer
Amgen
Summary
In this vital role you will work with the Sr. Engineering Manager and will provide engineering support for the Drug Substance facilities.
Job description
- Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems.
- Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
- Ensure necessary commissioning and qualification of systems is completed and interact with inspectors.
- Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
- Providing troubleshooting support to reduce production downtime.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, identifying spare parts, job plan development and supporting engineering runs.
- Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations.
- Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and reports.
- Use tools and techniques of continuous improvement wherever possible.
- Establish equipment monitoring parameters and control limits.
- Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving.
Requirements
- Doctorate degree OR Master’s degree and 2 years of engineering experience OR Bachelor’s degree and 4 years of engineering experience OR Associate’s degree and 8 years of engineering experience OR High school diploma / GED and 10 years of engineering experience
- Bachelor’s degree in Biotechnology, Industrial, Chemical or Mechanical Engineering
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
- Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Paid Time-off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.