Senior Engineer - Drug Product Process Engineering

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 bring a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing operations, technology transfer, process characterization, process validation and continuous process verification. Key to his role will be enabling offline. Key to this role will be knowledge of GMP procedures and systems, such as MES, EBRs, SOPs, SAP, LIMS, Trackwise, Maximo and more, to ensure full integration of product processes with site operations.

The Process Development Senior Engineer will have five following main responsibilities. 1) Lead process characterization of new aseptic fill finish manufacturing equipment for formulation (SS and SUS), vial washer & depyrogenation, sterile filtration, aseptic filling, lyophilization, capping and manual & automatic visual inspection. 2) Lead tech transfers of Amgens diverse portfolio of clinical and commercial parenteral products, conducting gap & risk assessments, onsite characterization, machinability and process performance qualifications (PPQ) runs, and authors/reviews EBRs, protocols, reports and regulatory filings. 3) Lead Process Validation and Continued Process Verification for all Commercial products manufactured in the plant. 4) Serve as process steward for the Commercial products post validation, supporting any life cycle management needs such as new raw material sources, scale changes and more. 5) Provide routine Manufacturing support by leading and managing a wide portfolio of projects spanning from introduction of new equipment or procedures, process improvements, digital data integration and more.

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 and PPQs for commercial manufacturing. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• 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).
• Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
• Provide input 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. Troubleshoots issues with drug product processing technologies and equipment.
• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement
• Interfaces 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 cross-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and presenting on findings and project status.

Basic Qualifications (to be reviewed and revised by HR)

• Doctorate degree OR
• Masters degree and 2 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 8 years of Engineering and/or Operations experience OR
• High school diploma/GED and 10 years of Engineering and/or Operations experience

Preferred Qualifications

• Advanced degree in engineering, biotechnology, life sciences or related discipline
• 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 manage 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).
• 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.

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