Title: Senior Engineer
Location: Thousand Oaks United States
Job Description:
JOB ID: R-202693 LOCATION: US - California - Thousand Oaks WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Dec. 05, 2024 CATEGORY: Engineering SALARY RANGE: 114,962.00 USD - 139,704.00 USD
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Engineer
What you will do
Let's do this! Let's change the world!
The Senior Engineer will join Amgen's Drug Product Process Engineering team in the Drug Product Technologies organization. Reporting to the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role will be responsible for commercial process validations to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility in Thousand Oaks. The candidate will play a key role in bringing a wide variety of high-quality licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. This role will be based in Thousand Oaks, CA. Some US or international travel may be required to support Amgen's drug product network.
Key responsibilities for this role include:
Leads / supports new product introductions (NPI) and lifecycle changes by integrating the product's process design and requirements with the site's procedures and capabilities to enable commercial tech transfers of parenteral drug products to Amgen's drug product manufacturing facility in Thousand Oaks.
Designs, implements and documents on-site DP characterization studies in support / ownership of technology transfer & PPQ.
Supports make-a-batch exercises to determine facility fit and identify gaps.
Author and/or own high-quality process technology transfer and other technical documents.
Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
Ensure that 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 learnt 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 of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic 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:
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 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, including remote and hybrid work arrangements, where possible
Apply now
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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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