Amgen

Career Category

Operations

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Associate Director - Engineering Technical Authority

What you will do

Let’s do this! Let’s change the world! In this vital role, you will be responsible for planning, design, construction, operations, and maintenance technical support of Amgen manufacturing infrastructure, worldwide. 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 Processes, Downstream Drug Substance Processes, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the ETA will demonstrate engineering expertise both in the company and industry to optimize the life cycle management of Amgen’s assets and be accountable for performance and reliability across multiple sites.

This position is in the Drug Substance Process Systems Engineering team with an emphasis on capital project design and execution for Amgen Rhode Island. Additional responsibilities will include end-to-end engineering support for future projects and technical global network management.

This role will include responsibilities as an Engineering Technical Lead (ETL) delivering on design, construction & commissioning for several large projects in Amgen Rhode Island and to ensure aligned implementation across Amgen’s growing drug substance network.

Specific responsibilities include but are not limited to:

• Planning: 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.
• Design: Lead design and equipment selection to optimize quality and cost across the total lifecycle of assets. Ensure appropriate use of technology and adherence to standards/practices. Approve appropriate exceptions to Amgen standards and specifications
• Construction: Use their ETA network to provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, and supporting overall project objectives.
• Commissioning: Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.
• Operations: Support the development of, or approve operational procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support non-conformance and preventive action investigations related to equipment failures.
• Maintenance: Support systems failure analysis, and 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 the network.
• Management: Lead their design teams and technical network. Make 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. Drive technical decisions within a project scope and networks standards that span the global networks. Remain current on state-of-the-art systems for the adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies, and regulatory bodies.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• High school diploma / GED and 14 years of Engineering or related technical field experience OR
• Associate’s degree and 12 years of Engineering or related technical field experience OR
• Bachelor’s degree and 7 years of Engineering or related technical field experience OR
• Master’s degree and 5 years of Engineering or related technical field experience OR
• Doctorate degree and 3 years of Engineering or related technical field experience

Preferred Qualifications:

• Bachelor’s or advanced degree in Chemical Engineering, Mechanical Engineering, or other engineering field with life science experience.
• At least 5 years working in Architectural & Engineering and Construction Management Companies during design and project execution.
• At least 5 years working in or supporting a biologics drug substance manufacturing facility
• Leadership of multi-functional teams to implement design and driving rapid decisions up to executive levels
• Strong understanding of Drug Substance process engineering and manufacturing unit operations.
• 15+ years of combined engineering experience including capital project design, with a consistent track record of delivering complex projects in a regulated environment.
• Extensive experience providing technical support to manufacturing processes, equipment, and facilities.
• Financial competence to deploy initiatives that add shareholder value.
• Excellent communication and interpersonal skills, with the ability to build strong relationships with team members at all levels of the organization and across Amgen’s international network.
• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

161,724.00 USD - 195,836.00 USD