Sr Engineer, PD Process Validation & Business Strategy
Amgen
7 days ago
On-site
Holly Springs, NC
Operations
SR. ENGINEER, PD PROCESS VALIDATION & BUSINESS STRATEGY
What You Will Do
- Lead the development of Process Validation/Process Performance Qualification strategy for New Products, aligned with regulatory guidelines and industry standards.
- Apply upstream (cell culture) and downstream (purification) bioprocessing knowledge to support process validation, technology transfer, and plant start-up.
- Lead execution of validation projects/protocols and collect data to complete process validation activities.
- Provide cross-functional process monitoring support as needed.
- Guide generation, resolution, and closure of deviations.
- Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize 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.
Basic Qualifications
- High school diploma/GED and 10 years of biologics process development/engineering/validation experience; OR
- Associate’s degree and 8 years; OR
- Bachelor’s degree and 4 years; OR
- Master’s degree and 2 years; OR
- Doctorate degree.
Preferred Qualifications
- 5+ years in process validation or downstream (purification) role in regulated (cGMP) biopharmaceutical manufacturing.
- Strong upstream/downstream manufacturing expertise.
- Validation experience including PPQ, master plans, protocols, and reports.
- Ability to multi-task and work in teams; demonstrated leadership and decision-making.
- Experience with scale-up, technology transfers, EBRs, deviations, CAPA, and change control.
- Excellent oral and verbal communication with diverse stakeholders.
Benefits (as stated)
- Total Rewards Plan: health/welfare plans, retirement savings plan, bonus/incentive, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline (applications accepted until a sufficient number is received or a candidate is selected).
What You Will Do
- Lead the development of Process Validation/Process Performance Qualification strategy for New Products, aligned with regulatory guidelines and industry standards.
- Apply upstream (cell culture) and downstream (purification) bioprocessing knowledge to support process validation, technology transfer, and plant start-up.
- Lead execution of validation projects/protocols and collect data to complete process validation activities.
- Provide cross-functional process monitoring support as needed.
- Guide generation, resolution, and closure of deviations.
- Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize 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.
Basic Qualifications
- High school diploma/GED and 10 years of biologics process development/engineering/validation experience; OR
- Associate’s degree and 8 years; OR
- Bachelor’s degree and 4 years; OR
- Master’s degree and 2 years; OR
- Doctorate degree.
Preferred Qualifications
- 5+ years in process validation or downstream (purification) role in regulated (cGMP) biopharmaceutical manufacturing.
- Strong upstream/downstream manufacturing expertise.
- Validation experience including PPQ, master plans, protocols, and reports.
- Ability to multi-task and work in teams; demonstrated leadership and decision-making.
- Experience with scale-up, technology transfers, EBRs, deviations, CAPA, and change control.
- Excellent oral and verbal communication with diverse stakeholders.
Benefits (as stated)
- Total Rewards Plan: health/welfare plans, retirement savings plan, bonus/incentive, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline (applications accepted until a sufficient number is received or a candidate is selected).