Sr Engineer, PD Process Validation & Business Strategy

Responsibilities

• Lead the development of Process Validation and Process Performance Qualification (PPQ) strategies for new products in alignment with regulatory guidelines.
• Execute validation projects, protocols, and data collection to ensure successful completion of process validation activities.
• Apply expertise in upstream (cell culture) and downstream (purification) bioprocessing to support technology transfer and plant start-up.
• Drive PD business strategy activities to optimize operations, improve network practices, and develop digital tools.
• Provide cross-functional support for process monitoring, regulatory filings, inspections, and CMC activities.
• Guide the generation, resolution, and closure of deviations to ensure safety and compliance.

Requirements

• Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience; OR
• Master’s degree and 2 years of relevant experience; OR
• Doctorate degree; OR
• High school diploma/GED with 10 years of experience or Associate’s degree with 8 years of experience.
• Strong understanding of upstream and downstream bioprocessing.
• Experience working within regulated cGMP environments.

Preferred Qualifications

• 5+ years of experience in process validation or downstream purification roles within biopharmaceutical manufacturing.
• In-depth expertise in PPQ, master plans, protocols, and reports.
• Experience with process scale-up, technology transfers, EBRs, deviations, CAPA, and change control.
• Demonstrated leadership, decision-making, and ability to work effectively in cross-functional teams.
• Excellent oral and verbal communication skills for interacting with diverse stakeholders.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging biologics manufacturing expertise to deliver innovative medicines worldwide.