Senior Engineer - ETA ADC/Peptide

Amgen • Thousand Oaks, CA

8d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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.

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

Nice To Haves

• 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.

Responsibilities

• Planning, design, construction, operations and maintenance technical support of Amgen manufacturing infrastructure, world-wide.
• Provide technical direction, leadership, guidance and support for a specific array of process systems within an area of responsibility.
• Leverage engineering expertise both in the company and industry to optimize the life cycle management of Amgen’s assets and is accountable for performance and reliability across multiple sites.
• 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.
• 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.
• 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed