Global MSAT Process Engineer III - Biologics

Evotec SE; Redmond (WA); On-site; USD 92,000 - 127,000; Full time

Job summary

Just-Evotec Biologics in Redmond, WA seeks a Process Engineer III to drive new equipment and technology adoption across the GMP biologics network. You will work with Manufacturing, MSAT, Automation, and vendors to bring innovations from concept to qualification.

You’ll own technical projects, develop validation plans, and support regulatory submissions while ensuring manufacturing readiness at both Just-Evotec and client sites.

Qualifications

• BS in engineering, sciences, or related life science engineering; 5+ years in Pharma/Biotech or MS with 2+ years.
• Experience with single-use processing equipment and technologies.
• Knowledge of process validation and regulatory expectations for biologics.
• Strong problem-solving and data interpretation skills.

Responsibilities

• Partner with stakeholders and vendors to evaluate and implement new manufacturing technologies.
• Develop URS and software specs to support qualification and validation.
• Collaborate with Automation on DCS design and integration with equipment.
• Support facility and utility requirement evaluations for equipment.
• Lead evaluation of single-use manifolds and assemblies.
• Develop testing data and validation packages with vendors.
• Support procurement, qualification, and lifecycle management of technologies.
• Create SOPs, training materials, and maintenance plans.
• Lead or assist investigations of deviations and non-conformances.
• Share knowledge across the manufacturing network and participate in audits.

Skills

Single-use processing

Cross-functional teamwork

cGMP knowledge

Regulatory knowledge

Data analysis

Communication

Education

BS in engineering / sciences / related life science

MS in engineering / life sciences

Tools

DeltaV automation

DCS design

Automation systems

Job description

Just-Evotec Biologics in Redmond, WA seeks a Process Engineer III to drive new equipment and technology adoption across the GMP biologics network. You will work with Manufacturing, MSAT, Automation, and vendors to bring innovations from concept to qualification.

You’ll own technical projects, develop validation plans, and support regulatory submissions while ensuring manufacturing readiness at both Just-Evotec and client sites.