Downstream System Owner

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. 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.

Downstream System Owner

What you will do

Lets do this. Lets change the this role support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation maintenance project management corporate engineering and manufacturing to develop and lead all aspects of the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

The Engineer role will provide direct engineering technical support as follows:

• Model leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for consistent equipment performance and reliability
• Be accountable for assigned results on key capital projects
• Suggest design modifications to address risks and design in quality and safety.
• Provide oversight for verification work developed by outsourced/contract verification staff.
• Act as a liaison between Engineering Automation Maintenance Instrumentation and Quality Assurance during project planning execution and closeout
• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices.
• Ensure safety during commissioning validation maintenance and manufacturing activities
• Initiate and drive continuous improvement activities and projects to completion.

Related Activities:

• Participate or lead when required multidisciplinary site teams e.g. Multi-functional Team Root Cause Analysis lead.
• Support Lean Transformation and Excellence in Operations process improvement by leading supporting and documenting improvement opportunities to reduce cost improve safety/quality or improve speed.
• Provide ad hoc technical support and guidance for manufacturing and maintenance
• Mentor and guidance to project teams and engineers using risk-based approaches
• Defend the equipment-specific calibration maintenance & validation as required during regulatory inspections
• Participate in internal audits and assess in conjunction with quality assurance
• Assist in developing and maintaining business metric performance

What we expect of you

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

Basic Qualifications:

• Masters degree

• OR

• Bachelors degree & 2 years of engineering and/or manufacturing experience

• Or

• Associates degree & 6 years of engineering and/or manufacturing experience

• Or

• High school diploma / GED & 8 years of engineering and/or manufacturing experience

Preferred Qualifications:

• Bachelors degree in engineering or another science-related field
• 7 years of relevant work experience with 5 years experience in operations/manufacturing environment
• Direct experience with regulated environments (FDA OSHA EPA etc.)
• Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes clean utilities facilities instruments and equipment
• Experience implementing risk-based verification on major GMP process equipment / automation projects including validation protocol development and execution
• Experience with combination product / medical device quality systems verification
• Process equipment knowledge basic principles of cell culture fermentation purification filling
• Equipment knowledge of downstream purification equipment: Chromatography Filtration Single-Use Systems
• Process automation knowledge fundamental understanding of automation infrastructure
• Knowledge of Delta V Rockwell and Plant Information Systems is a plus
• Strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making
• Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA LEAN Six Sigma etc.)

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