Senior Engineer - Drug Product Process Engineering
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Lets do this. Lets change the world. In this vital role you will be 1) Lead process characterization of aseptic fill finish manufacturing equipment for formulation, vial washer & depyrogenation, sterile filtration, aseptic filling, lyophilization, capping and manual & automatic visual inspection to produce clinical and commercial drug products. 2) Lead tech transfers of Amgens diverse portfolio of clinical and commercial parenteral products, conducting gap and risk assessments, conducting onsite characterization studies, supporting process performance qualifications (PPQ) runs, and authoring relevant technical protocols, reports and regulatory filings. 3) Leads development of Process Validation plans and Continued Process Verification for all Commercial products manufactured in the plant. 4) Serves as process steward for the Commercial products post validation, supporting any life cycle management needs. 5) Provides routine Manufacturing support by leading and managing a wide portfolio of projects spanning from equipment or procedure changes, process improvements, new raw materials, scale changes and more.
As part of Amgens Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated Senior Engineer to provide process development support to Amgens 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 manufacturing, technology transfer, process characterization, process validation and continuous process verification.\
The successful candidate will also be well versed in manual and automatic visual inspection principles, regulatory requirements and industry trends, inspection method development and qualification methodologies.Key Responsibilities
- Leads new product introductions and lifecycle changes into the manufacturing site as the receiving site PD lead and continues to serve as the Process Development SME for these products following completion of the transfer.
- Conducts site assessments by identifying characterization needs that ensure product, container and process fit to site, demonstrating in-depth equipment capabilities and site SOPs, as well as product quality sensitivities and specification requirements.
- Designs, plans, executes and documents in silico, off-line and on-line characterization studies and integrates established process operating ranges in recipes, batch records and other site procedures to ensure successful technology transfers.
- Development of validation plans for commercial manufacturing. Review and approve process validation protocols and assessments, while ensuring all aspects adhere 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).
- Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
- Assist in the development of existing validation program to ensure continued compliance to the vital regulations.
- Provide recommendations to site validation guidance documents.
- Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as required, and support PAI, GMP inspections in the plant
- Provide process development expertise for commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing
- Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply.
- 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a collaborative individual contributor with these qualifications.Basic Qualifications
- Doctorate degree OR
- Masters degree and 3 years of Engineering and/or Operations experience OR
- Bachelor's Degree and 5 years of Engineering and/or Operations experience OR
- Associate's degree and 10 years of Engineering and/or Operations experience OR
- High school diploma/GED and 12 years of Engineering and/or Operations experience
- Advanced degree in engineering, biotechnology, life sciences or related subject area
- 4+ 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.
- Strong technical writing skills and data analysis to author characterization protocols and reports, process transfer documents, validation plans, application notes, and more.
- Project management skills, including the ability to handle multiple 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 cross-functional team environment, and act on dynamic information at a rapid pace
- 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
- Capable of organizing and communicating complex technical concepts to enable business decisions
- Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
- Ability to use interpersonal skills to build strong technical relationships.
- Self-motivation, adaptability and a positive attitude.
- Excellent communication abilities, 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 process instructions, and stay in sync with company policies.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.