Global MSAT Principal Process Engineer - Tech Transfer

Evotec WD; Redmond (WA); On-site; USD 155,000 - 172,000; Full time

Job summary

Evotec is seeking a Principal Process Engineer to lead late-stage molecule tech transfer and PPQ campaigns across a global MSAT network. You will drive site-to-site tech transfer, develop robust validation and process control strategies, and oversee global documentation for GMP/commercial programs.

The role requires deep expertise in downstream/upstream processing, process validation, and regulatory CMC activities, with a track record of mentoring junior engineers and delivering cross-site

Qualifications

• Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
• Subject matter expert in downstream processing including continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration; knowledgeable in single-use bioreactors and perfusion technology.
• Subject matter expert in cell culture biopharmaceutical manufacturing or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies (Upstream).
• Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial PPQ campaigns/ campaigns.
• Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
• Experience developing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
• Solid background in statistical analysis.
• Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
• Working knowledge of manufacturing process equipment, DeltaV automation systems, and MES.
• Candidate must possess strong focus on quality and attention to detail as well as effective task/time management.
• Strategic mindset, ability to organize, analyze/interpret, and translate downstream expertise into global procedures/templates.
• Demonstrated skill managing and mentoring direct reports.

Responsibilities

• Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Lead site to site Tech Transfer activities.
• Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
• Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
• Lead the development and implementation templates for Process Validations and Continued Process Verification strategies.
• Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
• Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.

Skills

Downstream processing

Continuous chromatography

Viral filtration

Tangential flow filtration

Single-use bioreactors

Perfusion technology

Upstream processes

Process transfer

Process validation

GMP compliance

CMC documentation

Statistical analysis

FMEA

DeltaV automation

Manufacturing Execution Systems

Leadership

Mentoring

Education

Bachelor's degree

MS preferred

Tools

DeltaV automation

MES

Global MSAT tools

Job description

Evotec is seeking a Principal Process Engineer to lead late-stage molecule tech transfer and PPQ campaigns across a global MSAT network. You will drive site-to-site tech transfer, develop robust validation and process control strategies, and oversee global documentation for GMP/commercial programs.

The role requires deep expertise in downstream/upstream processing, process validation, and regulatory CMC activities, with a track record of mentoring junior engineers and delivering cross-site