Process Development Engineer

2 days ago

Thousand Oaks, California, United States National Guard Employment Network Full time
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 follow the next steps.

Job Summary

We are seeking a highly motivated Process Development Engineer to provide process development support to our parenteral biologics fill-finish manufacturing plant in Thousand Oaks, CA.

The successful candidate will play a key role in bringing high-quality clinical and licensed drug products to patients through demonstrated excellence in technology transfer, product and process characterization, process validation, and continuous process verification.

A focus on visual inspection compliance and process optimization is a major expectation within this role.

Key Responsibilities:
  • Engage in new product introduction (NPI) and ongoing manufacturing activities to enable and optimize our manual visual inspection (MVI) processes for an expanding product portfolio.
  • Support the establishment of robust tactical and strategic objectives related to visual inspection, with emphases on the evolving state of regulatory expectations and alignment within the Amgen global network.
  • Provide PD expertise for drug product visual inspection triages and investigations, including defect identification, maintenance of defect libraries, defect rate excursions, and forensics investigation of unknown defects.
  • Support the introduction of automated visual inspection (AVI) technology into the plant.
  • Generate, maintain, and optimize defect kits for training MVI operators, performing MVI studies, and developing AVI recipes.
  • Author, review, and data verify technical documents for all the above responsibilities per good documentation practices.
  • Provide subject matter expert guidance to regulatory submissions, responses to agency questions, and technology transfers to other Amgen plants.
  • Participate in knowledge management and dissemination activities to bolster MVI and AVI knowledge across the enterprise.
Additional Qualifications/Responsibilities

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with the following qualifications.

  • High school diploma / GED and 8 years of Engineering experience OR
  • Associate's degree and 6 years of Engineering experience OR
  • Bachelor's degree and 2 years of Engineering experience OR
  • Master's degree

The ideal candidate will have a degree in engineering, chemistry, physics, life sciences, or a related field, and experience in the pharmaceutical or biotechnology industry, including knowledge of Quality systems and current good manufacturing practice (CGMP) regulations.

The ability to learn and act upon dynamic information at a rapid pace in a multi-functional team environment is essential.

Proficiency in technical problem solving, critical thinking, and the delivery of value-adding solutions with limited oversight and technical direction is required.

What We Offer

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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.
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

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