Downstream System Owner
Amgen SA, Thousand Oaks, CA, United States
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. 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.
Downstream System Owner
What you will do
Let’s do this. Let’s change the world. In 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
Master’s degree
OR
Bachelor’s degree & 2 years of engineering and/or manufacturing experience
Or
Associate’s degree & 6 years of engineering and/or manufacturing experience
Or
High school diploma / GED & 8 years of engineering and/or manufacturing experience
Preferred Qualifications
Bachelor's 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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Equal Opportunity Employer
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.
#J-18808-Ljbffr
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. 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.
Downstream System Owner
What you will do
Let’s do this. Let’s change the world. In 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
Master’s degree
OR
Bachelor’s degree & 2 years of engineering and/or manufacturing experience
Or
Associate’s degree & 6 years of engineering and/or manufacturing experience
Or
High school diploma / GED & 8 years of engineering and/or manufacturing experience
Preferred Qualifications
Bachelor's 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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Equal Opportunity Employer
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.
#J-18808-Ljbffr