Global MSAT Process Engineer Leader

Evote

Union Hill-Novelty Hill (WA)

On-site

USD 134,000 - 154,000

Full time

6 days ago

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Job summary

Just-Evotec Biologics in Redmond, WA seeks a Principal Process Engineer to lead global MSAT process engineering projects. You will shape equipment, technologies, and single-use solutions across the manufacturing network, collaborating with MSAT, Manufacturing, Automation, and external vendors to improve efficiency and throughput.

You will guide technology evaluations, design strategies, and qualification efforts, while supporting regulatory submissions and site inspections.

Qualifications

BS in engineering, sciences, or related life science engineering with 12+ years of experience (or MS with 10+ years).
Demonstrated expertise in biopharmaceutical manufacturing processes and technologies (chromatography, filtration, viral clearance, etc.).
Experience with single-use bioprocessing equipment, instrumentation, and assemblies.
Experience leading technology implementation and validation for clinical and commercial manufacturing readiness.
Ability to work independently and lead cross-functional teams.
Strong data analysis and ability to present updates to senior leadership.

Responsibilities

Lead evaluation, design, development, and implementation of new and existing manufacturing technologies across the network.
Develop lifecycle and maintenance programs for GMP equipment and technologies.
Collaborate with vendors to evaluate innovative technologies for implantation into manufacturing processes.
Develop global design documents (URS, FDS) based on platform requirements and validation protocols.
Partner with Automation on DCS design and PLC integration.
Provide technical leadership for facility fit assessments, utility requirements, and CQV activities.
Advance single-use technologies and instrumentation for the platform.
Develop data packages and validation documentation for GMP deployment.
Create SOPs, process guidelines, and training for equipment and technologies.
Build life-cycle plans to support deployed equipment across the network.
Support regulatory submissions and site inspections with SME input.