What are the responsibilities and job description for the Specialist, Manufacturing Production Process Owner - Thousand Oaks CA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Specialist Manufacturing – Production Process Owner
What you will do
Let’s do this. Let’s change the world. At Amgen, our mission—to serve patients—drives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations at our Thousand Oaks (ATO) manufacturing site, you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. This role will be supporting Major Deviations from a DP Process Standpoint.
You will partner with cross-functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life-changing therapies to patients worldwide.
Key Responsibilities
Deviation and CAPA Management
Support timely investigation and resolution of manufacturing deviations.
Participate in root cause analyses (RCA) and human performance evaluations.
Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.
Documentation and Process Management
Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs).
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
Maintain documentation to accurately reflects operational practices and regulatory requirements.
Process Implementation and Project Execution
Support implementation of new processes, equipment, and major initiatives within Drug Product operations.
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations.
Operational Performance and Data Analytics
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement.
Develop and implement data-driven solutions to improve yield, reliability, and compliance.
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements.
Validation and Process Control
Assist in developing and executing process validation protocols and reports.
Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
Support establishment of process parameters, control limits, and performance reporting.
Change Control and Continuous Improvement
Support change control activities to ensure GMP, regulatory, and operational compliance.
Evaluate and justify process or equipment changes and assist with project execution.
Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations.
Auto req ID
479928BR
Minimum Education Required
Masters
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a highly organized and collaborative individual with strong project coordination, communication, and problem-solving skills.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of manufacturing experience OR
Bachelor’s degree and 4 years of manufacturing experience OR
Associate’s degree and 8 years of manufacturing experience OR
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Previous experience in Root Cause Analysis and Major Deviations
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions
Competencies for Success
Operational Excellence: Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements.
Technical Expertise: Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes.
Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines.
Accountability: Takes ownership of deliverables and ensures timely completion of commitments.
Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability.
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, 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.
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Specialist Manufacturing – Production Process Owner
What you will do
Let’s do this. Let’s change the world. At Amgen, our mission—to serve patients—drives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations at our Thousand Oaks (ATO) manufacturing site, you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. This role will be supporting Major Deviations from a DP Process Standpoint.
You will partner with cross-functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life-changing therapies to patients worldwide.
Key Responsibilities
Deviation and CAPA Management
Support timely investigation and resolution of manufacturing deviations.
Participate in root cause analyses (RCA) and human performance evaluations.
Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.
Documentation and Process Management
Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs).
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
Maintain documentation to accurately reflects operational practices and regulatory requirements.
Process Implementation and Project Execution
Support implementation of new processes, equipment, and major initiatives within Drug Product operations.
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations.
Operational Performance and Data Analytics
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement.
Develop and implement data-driven solutions to improve yield, reliability, and compliance.
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements.
Validation and Process Control
Assist in developing and executing process validation protocols and reports.
Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
Support establishment of process parameters, control limits, and performance reporting.
Change Control and Continuous Improvement
Support change control activities to ensure GMP, regulatory, and operational compliance.
Evaluate and justify process or equipment changes and assist with project execution.
Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations.
Auto req ID
479928BR
Minimum Education Required
Masters
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a highly organized and collaborative individual with strong project coordination, communication, and problem-solving skills.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of manufacturing experience OR
Bachelor’s degree and 4 years of manufacturing experience OR
Associate’s degree and 8 years of manufacturing experience OR
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Previous experience in Root Cause Analysis and Major Deviations
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions
Competencies for Success
Operational Excellence: Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements.
Technical Expertise: Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes.
Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines.
Accountability: Takes ownership of deliverables and ensures timely completion of commitments.
Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability.
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, 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.
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
Salary : $100,000