Specialist Manufacturing - Thousand Oaks CA

Specialist Manufacturing - Thousand Oaks CA

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 follow the next steps.

In this vital role you will bring a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, project management, process validation, and continuous process improvement. Periodic shift work or on call work is required.

Responsibilities:

• Initiate, revise, and approve manufacturing-controlled documents in the document management system.
• Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
• Implement new product introductions and major projects within Drug product (DP) operations.
• Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies.
• Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals.
• Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development.
• Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
• Assist in the development and execution of process validation protocols and reports.
• Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire).
• Ensure configurations align with process design, GMP requirements, and Amgen guidelines.
• Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support.
• Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.

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.

Thousand Oaks, California