Sr. Engineer Drug Substance Facility Projects

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Engineer Drug Substance Facility Projects

What you will do

Lets do this. Lets change the this role the Senior Engineer is responsible for planning design construction and operations and maintenance technical support of Amgen manufacturing infrastructure world-wide. The Engineering Technical Authority (TA) is responsible for technical direction leadership guidance and support for a specific array of process systems within an area of responsibility such as Upstream Processes Downstream Processes Fill/Finish CIP/SIP Utilities HVAC Packaging Devices etc. Through their team(s) of global and site technical subject matter experts the TA will demonstrate engineering expertise both in the company and industry to optimize the life cycle management of Amgens assets and is accountable for performance and reliability across multiple sites. This position is in the Process System Engineering team with initial emphasis on drug substance capital project support subsequent responsibilities may include technical network management and other project engineering leadership.

The successful candidates role will include responsibilities as a process equipment design as part of our Holly Springs DS facility process design team for Amgen-North Carolina (ANC). The individual will lead/participate in the design of equipment for various unit operations as part of the process and facility design team. They will be responsible for equipment design including providing direction to the A&E partner design SMEs and oversight of the equipment manufacturer during the fabrication phase. They will work with the team to develop plans and lead the execution of factory acceptance testing installation and integration design and execution.

Planning: Working with clients as appropriate (e.g. PD Quality Manufacturing) develop and specify engineering standards specifications equipment selection and design. Develop metrics to support procurement strategies for equipment inventory management spares and preventative maintenance. Manage and track changes to specifications and standards and system configuration.

Design: Ensure consistency to standards and good engineering practices. Lead design of new systems in support of projects and new technology deployment. Ensure designs optimize the total life cycle of the asset from both a cost and effectiveness standpoint.

Construction: Use their TA network to provide engineering support during the construction process including responses to RFIs resolving complex technical issues and conflicts 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 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.

Maintenance: 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.

Management: Lead their 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 others. 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.

This role involves travel up to 30% including overnight stays

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The engineer professional we seek is an employee with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of Engineering experience

Or

Bachelors degree and 4 years of Engineering experience

Or

Associates degree and 8 years of Engineering experience

Or

High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications:

• Demonstrated ability to lead the design of process equipment for new facilities and to balance competing factors to deliver equipment that meets process quality and operability requirements.
• Financial foresight to deploy initiatives that add shareholder value
• Excellent communications skills strong facilitation talent and executive presence to drive multi-functional objectives across Amgens international network
• Strong analytical skills to identify potential improvement opportunities
• 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 laws (e.g. cGMP building codes Boiler and Pressure Vessel codes etc.) to ensure compliance. Represent Amgen with outside firms technical societies and regulatory bodies.
• Ability to develop implement and apply tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics taking actions based on results.

What you can expect from 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 well 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.

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

Salary Range