Senior Process Engineer

4 weeks ago

Thousand Oaks, California, United States Amgen Full time
Transforming Lives through Innovative Process Engineering

At Amgen, we're committed to serving patients with serious illnesses. As a Senior Engineer in our Drug Product Process Engineering team, you'll play a critical role in bringing high-quality licensed drug products to patients worldwide.

Key Responsibilities:
  • Lead commercial process validations to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility in Thousand Oaks.
  • Design, implement, and document on-site DP characterization studies in support of technology transfer & PPQ.
  • Support make-a-batch exercises to determine facility fit and identify gaps.
  • Author and/or own high-quality process technology transfer and other technical documents.
  • Ensure all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training.
  • Ensure the site meets the quality requirements of its customers and applicable regulations (FDA, EU & global standards).
  • Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
  • Be a key contributor to regulatory filings throughout the authoring, editing, and submission process but also be responsible for responses to regulator questions as required, and support PAI, GMP inspections in the plant.
  • Build and sustain excellent relationships with partners – drug product teams, NPI, QA, Supply Chain, Process Development, and manufacturing teams to ensure alignment between program needs and site capabilities.
  • Build, maintain, and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models, development of templated documents, implementation of lessons learned, and more.
  • Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation.
  • Support commercial drug product manufacturing operations with technical evaluation of deviations.
  • Demonstrate a deep understanding of Amgen's drug product and primary container platforms, and support continuous evolution of platforms for agile tech transfers & improved manufacturability.
  • Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities, and lessons learned to deliver high-quality manufacturing processes.
  • Acts as single Point of Contact (POC) to drug product teams to provide expertise/knowledge of manufacturing site process capabilities and practices across an array of processing technologies.
What We Expect:

We're looking for a dynamic professional with the following qualifications:

  • High school diploma / GED and 10 years of Engineering and/or Operations experience OR
  • Associate's degree and 8 years of Engineering and/or Operations experience OR
  • Bachelor's degree and 4 years of Engineering and/or Operations experience OR
  • Master's degree and 2 years of Engineering and/or Operations experience OR
  • Doctorate degree

Preferred qualifications include:

  • Advanced Degree in engineering, biotechnology, life sciences, or related discipline with 4+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
  • Demonstrated expertise in leading functional area deliverables from planning through completion, with measurable impact to business outcomes.
  • Ability to set, and achieve, tactical and strategic goals in a dynamic manufacturing environment, with due considerations for competing priorities.
  • Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools.
  • Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
  • Experience in cGMP manufacturing environment, knowledge of cGMP's and other global regulatory requirements.
  • Demonstrated ability in leading multi-functional teams to advance complex projects to completion and positively influence peers and executive leadership on decision-making.
  • Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
  • Experience with building strong relationships in a matrix team environment, collaborating with Process Development, Project Management, Manufacturing, Regulatory, Quality, and Compliance.
  • Ability to learn and act on dynamic information at a rapid pace and escalate relevant issues to management when required.
  • Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes, and technical reports.
  • Proficiency in technical problem-solving, critical thinking, and delivery of technical solutions with limited oversight.
  • Demonstrated track record of taking initiative in identifying and implementing innovative approaches and ideas.
  • Capable of organizing and communicating complex technical concepts to enable business decisions.
  • Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
  • Demonstrated ability to use interpersonal skills to build strong technical relationships.
  • Self-motivation, adaptability, and a positive attitude.
  • Excellent communication skills, both oral and written.
  • Ability to elevate relevant issues to project lead and line-management.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
What We Offer:

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, including remote and hybrid work arrangements, where possible.

Apply now for a career that defies imagination. Objects in your future are closer than they appear. Join us.

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