Process Engineer III, NPI – Site MSAT
Evotec
June 25, 2026
On-site
Seattle, WA
Operations
Responsibilities:
- Lead stakeholders to implement the NPI process at J.POD Redmond and Seattle to support start and rapid scale-up of commercial GMP manufacturing.
- Partner with Product and Process Design to coordinate efficient scale-up/transfer and integrate process knowledge into manufacturing.
- Partner with Supply Chain for Bill of Materials development and demand planning for new products.
- Partner with Engineering and Digital to conduct facility fit assessments and plan system updates for new product introduction.
- Partner with Manufacturing to develop batch records, robust processes, and technology solutions for new product introduction.
- Partner with Quality, Validation, and Global MSAT to develop/implement process validation and comparability studies leading to successful product registration.
- Participate/lead NPI investigations and execute effective CAPA with impacted groups.
- Apply Operational Excellence principles to drive continuous improvement in NPI activities.
Qualifications:
- Masters (or Bachelors) in relevant field/program; 3+ (5+) years pharmaceutical/biotech experience.
- Biologics drug substance tech transfer experience, including first-in-human and early-stage clinical manufacturing.
- Late-stage clinical/commercial biologics drug substance manufacturing experience; process validation/PPQ leadership.
- Self-directed leadership and proven record of accomplishment in GMP pharma/biotech.
- Cell culture, purification, and solution preparation experience using disposable-based technologies.
- Knowledge of US FDA CFRs, European EMA, and ICH guidelines for biological drug substance manufacturing.
- Strong interpersonal and communication skills.
Preferred Qualifications:
- ~2 years leading biopharma New Product Introduction programs.
- Audit/inspection experience as presenter or support.
- Leadership to drive change and influence stakeholders.
- Risk assessment/management experience; Quality by Design; submission package development; client communications.
Benefits (as stated): Base pay range $92,400–$126,500; discretionary annual bonus; Medical/Dental/Vision; disability; basic life insurance; 401k match; flexible work; paid time off/holidays; wellness and transportation benefits.
Application Instructions:
- Apply today.
- Lead stakeholders to implement the NPI process at J.POD Redmond and Seattle to support start and rapid scale-up of commercial GMP manufacturing.
- Partner with Product and Process Design to coordinate efficient scale-up/transfer and integrate process knowledge into manufacturing.
- Partner with Supply Chain for Bill of Materials development and demand planning for new products.
- Partner with Engineering and Digital to conduct facility fit assessments and plan system updates for new product introduction.
- Partner with Manufacturing to develop batch records, robust processes, and technology solutions for new product introduction.
- Partner with Quality, Validation, and Global MSAT to develop/implement process validation and comparability studies leading to successful product registration.
- Participate/lead NPI investigations and execute effective CAPA with impacted groups.
- Apply Operational Excellence principles to drive continuous improvement in NPI activities.
Qualifications:
- Masters (or Bachelors) in relevant field/program; 3+ (5+) years pharmaceutical/biotech experience.
- Biologics drug substance tech transfer experience, including first-in-human and early-stage clinical manufacturing.
- Late-stage clinical/commercial biologics drug substance manufacturing experience; process validation/PPQ leadership.
- Self-directed leadership and proven record of accomplishment in GMP pharma/biotech.
- Cell culture, purification, and solution preparation experience using disposable-based technologies.
- Knowledge of US FDA CFRs, European EMA, and ICH guidelines for biological drug substance manufacturing.
- Strong interpersonal and communication skills.
Preferred Qualifications:
- ~2 years leading biopharma New Product Introduction programs.
- Audit/inspection experience as presenter or support.
- Leadership to drive change and influence stakeholders.
- Risk assessment/management experience; Quality by Design; submission package development; client communications.
Benefits (as stated): Base pay range $92,400–$126,500; discretionary annual bonus; Medical/Dental/Vision; disability; basic life insurance; 401k match; flexible work; paid time off/holidays; wellness and transportation benefits.
Application Instructions:
- Apply today.