Process Engineer III - Site Based, Redmond, WA
Evotec
8 hours ago
On-site
Redmond, WA
Operations
Responsibilities:
- Support downstream technology transfer of late-stage molecule/commercial manufacturing and/or PPQ campaign support.
- Support site-to-site tech transfer activities.
- Perform gap analysis/risk assessments; ensure mitigation plans are in place; build design spaces (PAR & NOR ranges) for critical process parameters to support validation and late-stage/commercial manufacturing.
- Develop, review, and approve technical documentation (global protocols, batch records, and reports) related to engineering, GMP, and PPQ runs.
- 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/or process control strategies for Phase III and commercial programs for receiving sites.
Qualifications:
- Bachelor’s degree in engineering/sciences or related with 5+ years relevant experience (2 years with an MS).
- Experience supporting process/technology transfer projects in biopharmaceutical industry (commercial manufacturing campaign support a plus).
- Familiarity with process risk assessment tools (e.g., FMEA), process modeling, and process trending.
- Solid downstream processing knowledge: chromatography (including continuous chromatography), large-scale column packing, viral filtration, and tangential flow filtration (manufacturing or process development).
- Solid GMP concepts/quality systems for tech transfer and process validation.
- Hands-on disposable-based downstream manufacturing from bench to commercial scale.
- Working knowledge of manufacturing equipment and automation systems.
- Strong quality focus, attention to detail, time management, and ability to analyze/interpret/communicate process data.
- Interpersonal/team collaboration; excellent oral and written communication.
Preferred:
- Downstream/disposable manufacturing experience at manufacturing or bench scale.
- Ability to solve complex technical problems; serve as technical resource.
- Independence and ability to lead projects.
- Ability to navigate global regulatory CMC documents.
- Experience supporting late-stage manufacturing/tech transfer/process validation.
- DeltaV experience.
Benefits:
- Medical, Dental, Vision; short-term and long-term disability; company-paid basic life insurance; 401k company match; generous paid time off and paid holidays; wellness and transportation benefits.
Application:
- Apply today.
- Support downstream technology transfer of late-stage molecule/commercial manufacturing and/or PPQ campaign support.
- Support site-to-site tech transfer activities.
- Perform gap analysis/risk assessments; ensure mitigation plans are in place; build design spaces (PAR & NOR ranges) for critical process parameters to support validation and late-stage/commercial manufacturing.
- Develop, review, and approve technical documentation (global protocols, batch records, and reports) related to engineering, GMP, and PPQ runs.
- 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/or process control strategies for Phase III and commercial programs for receiving sites.
Qualifications:
- Bachelor’s degree in engineering/sciences or related with 5+ years relevant experience (2 years with an MS).
- Experience supporting process/technology transfer projects in biopharmaceutical industry (commercial manufacturing campaign support a plus).
- Familiarity with process risk assessment tools (e.g., FMEA), process modeling, and process trending.
- Solid downstream processing knowledge: chromatography (including continuous chromatography), large-scale column packing, viral filtration, and tangential flow filtration (manufacturing or process development).
- Solid GMP concepts/quality systems for tech transfer and process validation.
- Hands-on disposable-based downstream manufacturing from bench to commercial scale.
- Working knowledge of manufacturing equipment and automation systems.
- Strong quality focus, attention to detail, time management, and ability to analyze/interpret/communicate process data.
- Interpersonal/team collaboration; excellent oral and written communication.
Preferred:
- Downstream/disposable manufacturing experience at manufacturing or bench scale.
- Ability to solve complex technical problems; serve as technical resource.
- Independence and ability to lead projects.
- Ability to navigate global regulatory CMC documents.
- Experience supporting late-stage manufacturing/tech transfer/process validation.
- DeltaV experience.
Benefits:
- Medical, Dental, Vision; short-term and long-term disability; company-paid basic life insurance; 401k company match; generous paid time off and paid holidays; wellness and transportation benefits.
Application:
- Apply today.