Process Development Engineer
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Engineer
What you will do
Let’s do this! Let’s change the world! As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly dynamic Engineer to provide process development support to Amgen’s clinical and commercial sterile fill-finish manufacturing plant in Thousand Oaks, CA. The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. This position is based in Thousand Oaks, CA at the Amgen headquarters.
New Product Introductions
Characterizes drug product process parameters for DP manufacturing process, designs and executes off-line and on-line studies to fully characterize the process, and ensure successful technology transfer.
Designs, implements and documents off-line and on-site DP characterization studies.
Designs, plans and provides floor support to on-site engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization.
Supports make-a-batch exercises to determine facility fit and identify gaps.
Process Validation & Regulatory Support
Development of validation plans, PPQ protocols and reports for commercial manufacturing in alignment with GMP quality system documentation standards.
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 laws/regulations (FDA, EU & global standards).
Participate and lead in validation cross-functional teams at the site to ensure alignment to required policies and procedures.
Provide recommendations to site validation guidance documents.
Be a key contributor to regulatory filings as part of the NPI process by authoring, editing and submitting filings as well as assist in responding to regulator questions as required.
Support PAI and GMP inspections in the plant.
Lead and implement characterization studies on the floor including process characterization, tech transfer studies, process validation, and ongoing commercial manufacturing.
Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment.
Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement.
Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing.
Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations.
Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and present findings and project status.
Aseptic DP Technology leadership
Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global cross-functional teams for shared best practices in technical advancements across Amgen clinical and commercial fill-finish plants.
Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing.
Work individually and with a team of engineers to design, implement and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization
Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.
DP Network support
Establishes strong working relationships with partner sites across DP Manufacturing network to champion 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 guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection.
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.
Master's Degree OR
Bachelor's Degree and 2 years of Scientific, Engineering and/or Operations experience OR
Associate's degree and 6 years of Scientific, Engineering and/or Operations experience OR
High school diploma/GED and 8 years of Scientific, Engineering and/or Operations experience
Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related technical field of study in biotechnology, life sciences or related field.
2+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites
Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
Project management skills, including the ability to handle numerous projects and evaluate project resource requirements.
Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions.
Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace
Ability to independently design and implement 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
Capable of organizing and communicating complex technical concepts to enable business decisions
Solid understanding of Quality systems and Drug Product Manufacturing (GMP).s
Demonstrated ability to use interpersonal skills to build strong technical relationships.
Self-motivation, adaptability and a positive demeanor.
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 align with company policies.
What you can expect of us
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.
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.
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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..
Salary Range87,178.00 USD - 107,393.00 USD