Validation Engineer II - Site Based, Redmond, WA
Evotec
June 27, 2026
On-site
Redmond, WA
Operations
What You’ll Do:
- Execute FUSE commissioning and validation for early-stage clinical manufacturing, late-stage/ commercial manufacturing, and/or PPQ campaign support.
- Generate/review validation lifecycle technical documentation (protocols, reports, lifecycle documents).
- Collaborate to develop Validation Master Plans, support validation execution, and perform risk assessments.
- Lead development and implementation of validation templates and workflows.
- Support governance policies and SOPs for FUSE commissioning.
- Support validation deviation resolution (troubleshooting, root cause analysis).
- Support periodic review of qualified/validated FUSE across JUST WA sites.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
Who You Are (Qualifications):
- Bachelor’s degree in engineering science (or related) + minimum 2 years relevant experience.
- Proven experience executing commissioning/validation of FUSE.
- Understanding of GMP concepts and quality systems.
- Knowledge of science-and-risk-based qualification standards for systems/equipment/utilities/facilities.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Experience with quality risk management.
- Problem-solving/critical thinking; strong interpersonal/team skills.
- Self-starter with strong mechanical aptitude.
- Ability to work independently and cross-functionally in a fast-paced environment.
- cGMP knowledge; experience writing manufacturing technical documents.
- Experience leading technical projects and managing timelines with vendors.
- Strong quality focus, attention to detail, and task/time management.
Preferred Qualifications:
- Biologics manufacturing process and automation (e.g., DeltaV).
- Single-use technologies; experience with DCS, BAS, PLC, SCADA, PI, MES.
- Utilities/facilities, computerized systems, analytical equipment, process validation and clean validation.
- Authority inspection/audit support.
Compensation/Benefits (as stated):
- Base pay range: $79,800–$109,250; plus discretionary annual bonus and comprehensive benefits (Medical, Dental, Vision, short/long-term disability, basic life insurance, 401k match, flexible work, paid time off/holidays, wellness, transportation).
Application Instructions:
- Apply today.
- Execute FUSE commissioning and validation for early-stage clinical manufacturing, late-stage/ commercial manufacturing, and/or PPQ campaign support.
- Generate/review validation lifecycle technical documentation (protocols, reports, lifecycle documents).
- Collaborate to develop Validation Master Plans, support validation execution, and perform risk assessments.
- Lead development and implementation of validation templates and workflows.
- Support governance policies and SOPs for FUSE commissioning.
- Support validation deviation resolution (troubleshooting, root cause analysis).
- Support periodic review of qualified/validated FUSE across JUST WA sites.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
Who You Are (Qualifications):
- Bachelor’s degree in engineering science (or related) + minimum 2 years relevant experience.
- Proven experience executing commissioning/validation of FUSE.
- Understanding of GMP concepts and quality systems.
- Knowledge of science-and-risk-based qualification standards for systems/equipment/utilities/facilities.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Experience with quality risk management.
- Problem-solving/critical thinking; strong interpersonal/team skills.
- Self-starter with strong mechanical aptitude.
- Ability to work independently and cross-functionally in a fast-paced environment.
- cGMP knowledge; experience writing manufacturing technical documents.
- Experience leading technical projects and managing timelines with vendors.
- Strong quality focus, attention to detail, and task/time management.
Preferred Qualifications:
- Biologics manufacturing process and automation (e.g., DeltaV).
- Single-use technologies; experience with DCS, BAS, PLC, SCADA, PI, MES.
- Utilities/facilities, computerized systems, analytical equipment, process validation and clean validation.
- Authority inspection/audit support.
Compensation/Benefits (as stated):
- Base pay range: $79,800–$109,250; plus discretionary annual bonus and comprehensive benefits (Medical, Dental, Vision, short/long-term disability, basic life insurance, 401k match, flexible work, paid time off/holidays, wellness, transportation).
Application Instructions:
- Apply today.