Global MSAT Lead: Principal Process Engineer

Cyprotex Limited; Redmond (WA); On-site; USD 155,000 - 172,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k match

Paid time off

Job summary

Just Evotec Biologics is seeking a highly experienced Principal Process Engineer to lead late-stage molecule tech transfer and PPQ campaigns across a global MSAT network. The role focuses on process control, validation strategies, and regulatory documentation for biotherapeutics manufacturing.

You will guide site-to-site tech transfer, develop global templates, and support regulatory submissions and inspections while mentoring junior engineers.

Qualifications

• Experience leading tech transfer for late-stage clinical manufacturing and PPQ campaigns.
• Strong GMP understanding and ability to author regulatory CMC documents.
• Proven ability to manage risk, perform FMEA, and drive process validation activities.

Responsibilities

• Lead technology transfer activities across sites and PPQ campaigns.
• Develop and implement process validation templates and CTAs.
• Oversee regulatory CMC documentation and inspection support.
• Analyze process data and perform periodic reviews across sites.

Skills

Downstream processing

Cell culture

Tech transfer

GMP knowledge

Process validation

Regulatory CMC

FMEA

DeltaV & MES

Data analysis

Project leadership

Education

Bachelor’s degree in engineering

MS in related field

Tools

DeltaV automation

Manufacturing Execution Systems (MES)

Job description

Just Evotec Biologics is seeking a highly experienced Principal Process Engineer to lead late-stage molecule tech transfer and PPQ campaigns across a global MSAT network. The role focuses on process control, validation strategies, and regulatory documentation for biotherapeutics manufacturing.

You will guide site-to-site tech transfer, develop global templates, and support regulatory submissions and inspections while mentoring junior engineers.