Senior Engineer - ETA ADC/Peptide

About the role

Amgen is looking for a Senior Engineer in its Drug Substance Process Systems Engineering team, with an emphasis on antibody drug conjugate (ADC) and peptide manufacturing. The Engineering Technical Authority (ETA) provides technical direction, leadership, guidance and support for process systems such as Upstream/Downstream Drug Substance, API, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices and more, covering worldwide manufacturing infrastructure. The preferred location is Thousand Oaks, California, with San Francisco, Boston and North Carolina also considered.

Key responsibilities

• Act as a domain expert on containment, facility and process equipment during design, construction and commissioning for the ADC and peptide portfolio
• Translate business needs into engineering solutions, lead alternative analyses and publish and maintain engineering standards and specifications
• Lead design and equipment selection to optimise quality and cost across the asset lifecycle, and approve exceptions to standards
• Support construction, commissioning and qualification, including responding to RFIs and resolving technical issues
• Develop and approve operation procedures, review performance data and support NC/CAPA investigations and failure analysis
• Approve maintenance standards, support reliability improvements and mentor other engineers in the network
• Represent Amgen with outside firms, technical societies and regulatory bodies

Required profile

• Basic: doctorate; or master's degree with 2 years of engineering experience; or bachelor's degree with 4 years; or associate's degree with 8 years; or high school diploma/GED with 10 years
• Preferred: chemical, mechanical or other engineering degree with life science experience
• Preferred: 5+ years in capital project design in a regulated environment, and 5+ years in peptide manufacturing and/or ADC engineering
• Preferred: extensive technical support experience for manufacturing processes, equipment and facilities

Required skills

• Knowledge of cGMP, building codes and boiler and pressure vessel codes
• Knowledge of industry trends such as regulatory compliance, technology, human performance programs, sustainability and asset insurance
• Ability to manage many projects at once in a fast-paced environment

What we offer

• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans and flexible work models where possible