Enter a job title or keyword
Specialist, Manufacturing Production Process Owner Thousand Oaks CA
Job Location:
Job Location:
Thousand Oaks, CA - USA
Monthly Salary:
$ 145502 - 145502
Monthly Salary:
Posted:
31 July 2026 (30+ days ago)
Posted:
Application Deadline:
28 October 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans 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
Lets do this. Lets change the world. At Amgen our missionto serve patientsdrives 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 teamsincluding Engineering Quality Process Development and Operationsto implement process improvements support new technology introductions and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgens 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 Amgens 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.
What you will do
Lets do this. Lets change the world. At Amgen our missionto serve patientsdrives 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 teamsincluding Engineering Quality Process Development and Operationsto implement process improvements support new technology introductions and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgens 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 Amgens 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.
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
Masters degree and 2 years of manufacturing experience OR
Bachelors degree and 4 years of manufacturing experience OR
Associates degree and 8 years of manufacturing experience OR
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications:
Advanced degree (Masters 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 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.
Salary Range
107545.40USD -145502.60 USD
Required Experience:
IC
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
