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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. 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 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 I DOWNSTREAM 2º SHIFT

What you will do

Lets do this. Lets change the this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design build commission and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations focusing on Downstream Process engineering

APPLICABLE SHIFTS AVAILABLE:

- 2ndShift: 3pm to 11pm Monday through Friday

Responsibilities include:

• Provide system ownership for Biopharmaceutical process equipment. Identify support and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design specification and supporting the construction startup and validation of equipment.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing Quality Process Development Maintenance network partners) to ensure reliable plant operations.
• Develop equipment maintenance programs ensure the availability of spare parts and coordinating maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• System guidance to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments implementing equipment modifications and supporting engineering runs.
• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.
• Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.
• Ensure plant readiness and quality and regulatory compliance for internal audits external agency audits and partner audits for the process equipment.
• Lead new product/technology introductions by performing engineering assessments equipment performance risk assessments identifying gaps and owning their remediation implementing equipment modifications and supporting engineering runs.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience OR
• Associates degree and 8 years Engineering experience OR
• Bachelors degree and 4 years of Engineering experience OR
• Masters degree and 2 years of Engineering experience OR
• Doctorate degree

Preferred Qualifications:

• Bachelors degree in Chemical or Mechanical Engineering
• 6 years of relevant work experience with 5 years experience in Biopharmaceutical operations/manufacturing environment with a focus on Downstream unit operations
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors centrifugation chromatography tangential flow filtration as well as other equipment needed to support these processes such as autoclaves clean in place (CIP) systems washers clean steam water for injection etc.
• Ability to analyze problems develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Data Analytics Root Cause Analysis (RCA) Statistical Process Control (SPC) Six Sigma Predictive Maintenance etc.)
• Experience working in a regulated environment (e.g. cGMP OSHA EPA etc.) and familiarity with GMP quality systems/processes such as change control non-conformances corrective and preventative actions and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications introduction of new processes and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement construction startup and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent ambitious organized able to multi-task in project environments and skilled in communication facilitation and teamwork
• Collaborative teammate prepared to work in and embrace a team-based environment that relies on communication for effective decision-making
• Strong leadership technical writing and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations requiring occasional after-hours engineering coverage
• Ability for domestic/international travel (10%)

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 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range