Senior Engineer - ETA ADC/Peptide
Amgen
Summary
In this vital role you will be responsible for planning, design, construction, operations and maintenance technical support of Amgen manufacturing infrastructure, world-wide.
Job description
The Engineering Technical Authority (ETA) is responsible for technical direction, leadership, guidance and support for a specific array of process systems within an area of responsibility, such as Upstream Drug Substance, Downstream Drug Substance, API, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc.
This position is in the Drug Substance Process Systems Engineering team with an emphasis on antibody drug conjugate and peptide manufacturing. This role will include responsibilities as a domain expert on containment, facility, and process equipment during design, construction & commissioning for Amgen’s Antibody Drug Conjugate and Peptide portfolio.
- Translate business needs into engineering technology solutions.
- Lead analysis of alternatives and recommendations for technical solutions in major projects.
- Publish and maintain engineering standards and specifications.
- Lead Engineering in development and execution of corporate environmental sustainability goals & projects.
- Lead design and equipment selection to optimize quality and cost across the total lifecycle of assets.
- Ensure appropriate use of technology, and alignment to standards.
- Approve appropriate exceptions to Amgen standards and specifications.
- Use their ETA network to provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, supporting overall project objectives.
- Ensure commissioning and qualification standards are developed and used.
- Use their network to provide engineering support to commissioning and qualification.
- Support development of, or approve operation procedures for the safe, efficient and effective operations of systems.
- Review performance data and make recommendations for improvement of system operations.
- Support NC/CAPA investigations related to equipment failures.
- Support systems failure analysis, approve maintenance standards and techniques.
- Support and review reliability and failure data, and implement actions to improve effectiveness, and reliability of systems.
- Assist the sites in system troubleshooting and take action as necessary to prevent future occurrence throughout network.
- Lead design teams and technical network.
- Makes use of expertise at the site and corporate levels for solving problems and deploying solutions across all sites.
- Identify and resolve issues and conflicts.
- Provide mentoring of other members in their network.
- Ensure technical decisions for assigned systems are optimized with those managed by other ETAs.
- Remain current on state-of-the-art for systems for adoption of new techniques and technology within Amgen.
- Represent Amgen with outside firms, technical societies and regulatory bodies.
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 or advanced degree in Chemical Engineering, Mechanical Engineering, or other engineering subject area with life science experience
- Minimum of 5 years of experience in capital project design, with a proven track record of delivering complex projects in a regulated environment
- Minimum 5 years of experience working in Peptide manufacturing and/or Antibody Drug Conjugate engineering, preferably translating bench chemistry to kilo labs and manufacturing scales
- Extensive experience providing technical support to manufacturing processes, equipment and facilities
- Financial foresight to deploy initiatives that add shareholder value
- Excellent communication and interpersonal skills, with the ability to build strong relationships with partners at all levels of the organization and across Amgen’s international network
- Proven ability to manage numerous projects simultaneously and deliver results in a fast-paced environment
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation
- Knowledge of applicable regulations (e.g. cGMP, building codes, Boiler and Pressure Vessel codes, etc.), to ensure compliance
- Represent Amgen with outside firms, technical societies and regulatory bodies
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Award-winning Time-off Plans
- 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.