Sr Engineer, PD Process Validation & Business Strategy Job at Amgen (Holly Springs)

Job Description

In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.

Job Responsibility

Lead the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards
Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation, technology transfer support, and plant start-up
Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities
Provide cross-functional process monitoring support as needed
Provide guidance for the generation, resolution and closure of deviations
Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations
Ensure safety and compliance of process development activities
Provide process validation floor process support as required
Lead process validation support for regulatory filing, inspection, and other CMC activities

Requirements

High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
Associate's degree and 8 years of biologics process development, process engineering, or process validation experience OR
Bachelor's degree and 4 years of biologics process development, process engineering, or process validation experience OR
Master's degree and 2 years of biologics process development, process engineering, or process validation experience OR
Doctorate degree

Nice to have

5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
Independently motivated with successful ability to multi-task and work in teams
Demonstrated leadership skills and decision-making experience
Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes
Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

What we offer

Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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Sr Engineer, PD Process Validation & Business Strategy

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