Senior Downstream Process Engineer – Tech Transfer

Cyprotex; Redmond (WA); On-site; USD 92,400 - 126,500; Full time

Benefits offered by this job

Growth

Flexible work

Inclusive culture

Innovative projects

Big ideas

Job summary

Just Evotec Biologics is seeking a Process Engineer III to lead downstream tech transfer across the Global MSAT network. You will drive late-stage and commercial programs, collaborating with site teams to implement robust transfer strategies and build documentation for regulatory submissions.

The role emphasizes process knowledge, risk assessment, and continuous improvement within GMP frameworks, enabling scalable biologics manufacturing and tech transfer across Just Evotec sites.

Qualifications

• Bachelor’s degree in engineering, sciences, or related program with 5+ years of relevant experience, 2 years of experience with an MS degree.
• Experience supporting process transfer/technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
• Familiar with process risk assessment tools (e.g., FMEA) developing process models, and process trending.
• Solid understanding of downstream processing including process chromatography and continuous chromatography, large-scale column packing, viral filtration, and tangential flow filtration.

Responsibilities

• Support downstream technology transfer for Late-Stage molecule/ commercial manufacturing and PPQ support.
• Support site to site Tech Transfer activities
• Ensure gap analyses/risks assessments are performed and mitigation plans are in place for validation and CT of late stage/commercial operations.
• Develop, review, and approve technical documentation including global protocols for performance qualifications, batch records, and reports.
• Author templates for Process Validations and Continued Process Verification strategies.
• Analyze process data including annual periodic reviews across Manufacturing sites.
• Author Process transfer documents and Process Control strategies for phase III and commercial programs for receiving sites.

Skills

Downstream processing

Tech transfer experience

GMP knowledge

Data analysis

DeltaV process control

Project collaboration

Problem solving

Education

Bachelor’s degree in engineering or sciences

MS degree (2 yrs experience)

Tools

DeltaV

Job description

Just Evotec Biologics is seeking a Process Engineer III to lead downstream tech transfer across the Global MSAT network. You will drive late-stage and commercial programs, collaborating with site teams to implement robust transfer strategies and build documentation for regulatory submissions.

The role emphasizes process knowledge, risk assessment, and continuous improvement within GMP frameworks, enabling scalable biologics manufacturing and tech transfer across Just Evotec sites.