Principal Process Engineer
Evotec
6 days ago
On-site
Redmond, WA
Operations
The selected candidate for Principal Process Engineer (GMSAT Process Engineering) will lead the team responsible for design and development of new equipment, technologies, and single-use materials for the biomanufacturing network. Lead cross-functional evaluations of technologies to improve and optimize the biomanufacturing platform, develop support documentation for implantation into the global processing platform, and provide technical/operational support to Site MSAT and Manufacturing Operations. May provide person-in-plant support, assist with regulatory submissions, and support regulatory and site inspections.
What You’ll Do:
- Develop strategies for design/development of new and existing technologies.
- Develop lifecycle and maintenance management program for GMP equipment/technologies.
- Support evaluation and approval of innovative technologies via project governance.
- Partner with stakeholders/vendors to improve efficiency and throughput.
- Develop global design documents (URS, software functional specs) and support validation CQV protocols.
- Collaborate on DCS design and PLC-to-DCS integration.
- Support utility/layout evaluations and associated CQV activities.
- Evaluate single-use technologies for data acquisition and suitability.
- Develop data/validation packages for GMP implementation with vendors.
- Create business processes, guidelines, SOPs, and training for equipment/technologies.
- Build maintenance & life cycle plans.
- Support Non-Conformance, CAPAs, and process impact evaluations.
Who You Are:
- BS (engineering/sciences/life science engineering) +12 years; or MS +10 years in pharma/biotech/life sciences.
- SME in cell culture biopharmaceutical manufacturing (chromatography, filtration, viral clearance, formulation).
- Upstream cell culture/perfusion processing knowledge.
- Experience with GMP single-use instrumentation/assemblies; leachables & extractables knowledge.
- Leading technology implementation/validation for clinical/commercial readiness.
- Facility fit assessments and process validation experience.
- Independent and cross-functional leadership; quality and attention to detail.
- Ability to organize/analyze/present data to senior leadership.
Additional Preferred Qualifications:
- Continuous process monitoring/manufacturing strategy oversight.
- DeltaV automation experience.
- Experience leading CQV plans/protocols; lead cross-functional projects.
Application:
- Take the leap and apply today.
What You’ll Do:
- Develop strategies for design/development of new and existing technologies.
- Develop lifecycle and maintenance management program for GMP equipment/technologies.
- Support evaluation and approval of innovative technologies via project governance.
- Partner with stakeholders/vendors to improve efficiency and throughput.
- Develop global design documents (URS, software functional specs) and support validation CQV protocols.
- Collaborate on DCS design and PLC-to-DCS integration.
- Support utility/layout evaluations and associated CQV activities.
- Evaluate single-use technologies for data acquisition and suitability.
- Develop data/validation packages for GMP implementation with vendors.
- Create business processes, guidelines, SOPs, and training for equipment/technologies.
- Build maintenance & life cycle plans.
- Support Non-Conformance, CAPAs, and process impact evaluations.
Who You Are:
- BS (engineering/sciences/life science engineering) +12 years; or MS +10 years in pharma/biotech/life sciences.
- SME in cell culture biopharmaceutical manufacturing (chromatography, filtration, viral clearance, formulation).
- Upstream cell culture/perfusion processing knowledge.
- Experience with GMP single-use instrumentation/assemblies; leachables & extractables knowledge.
- Leading technology implementation/validation for clinical/commercial readiness.
- Facility fit assessments and process validation experience.
- Independent and cross-functional leadership; quality and attention to detail.
- Ability to organize/analyze/present data to senior leadership.
Additional Preferred Qualifications:
- Continuous process monitoring/manufacturing strategy oversight.
- DeltaV automation experience.
- Experience leading CQV plans/protocols; lead cross-functional projects.
Application:
- Take the leap and apply today.