Validation Engineer II - Site Based, Redmond, WA
Evotec
6 months ago
On-site
Redmond, WA
Operations
Responsibilities:
- Execute FUSE commissioning and validation for early clinical manufacturing, late-stage/commercial manufacturing, and/or PPQ campaign support.
- Generate and review validation lifecycle documentation (validation master plans, protocols, and reports).
- Develop Validation Master Plans with cross-functional teams; support validation execution and risk assessments.
- Lead development/implementation of validation templates and workflows.
- Support governance policies and related SOPs for FUSE commissioning.
- Support validation deviation resolution (troubleshooting and root cause analysis).
- Perform periodic review of qualified/validated FUSE across JUST WA sites.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
Qualifications (Required):
- Bachelor’s degree in engineering science (or related) with at least 2 years relevant experience.
- Proven experience executing commissioning and validation of FUSE.
- Knowledge of GMP concepts/quality systems; science- and risk-based qualification standards.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Experience with quality risk management.
- Problem-solving/critical thinking; strong interpersonal/team skills.
- cGMP knowledge; experience writing manufacturing technical documents.
- Ability to manage timelines with external collaborators/vendors; strong quality focus and attention to detail.
Preferred:
- Biologics manufacturing process knowledge; process automation (e.g., DeltaV).
- Single-use technologies.
- Experience with DCS/BAS/PLC/SCADA/PI/MES; utilities/facilities and process/clean validation methodologies.
- Authority inspection/audit support involvement.
Benefits (as stated): discretionary annual bonus; medical/dental/vision; short- and long-term disability; basic life insurance; 401(k) match; flexible work; paid time off and paid holidays; wellness and transportation benefits.
Application instructions:
- “Take the leap and apply today.”
- Execute FUSE commissioning and validation for early clinical manufacturing, late-stage/commercial manufacturing, and/or PPQ campaign support.
- Generate and review validation lifecycle documentation (validation master plans, protocols, and reports).
- Develop Validation Master Plans with cross-functional teams; support validation execution and risk assessments.
- Lead development/implementation of validation templates and workflows.
- Support governance policies and related SOPs for FUSE commissioning.
- Support validation deviation resolution (troubleshooting and root cause analysis).
- Perform periodic review of qualified/validated FUSE across JUST WA sites.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
Qualifications (Required):
- Bachelor’s degree in engineering science (or related) with at least 2 years relevant experience.
- Proven experience executing commissioning and validation of FUSE.
- Knowledge of GMP concepts/quality systems; science- and risk-based qualification standards.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Experience with quality risk management.
- Problem-solving/critical thinking; strong interpersonal/team skills.
- cGMP knowledge; experience writing manufacturing technical documents.
- Ability to manage timelines with external collaborators/vendors; strong quality focus and attention to detail.
Preferred:
- Biologics manufacturing process knowledge; process automation (e.g., DeltaV).
- Single-use technologies.
- Experience with DCS/BAS/PLC/SCADA/PI/MES; utilities/facilities and process/clean validation methodologies.
- Authority inspection/audit support involvement.
Benefits (as stated): discretionary annual bonus; medical/dental/vision; short- and long-term disability; basic life insurance; 401(k) match; flexible work; paid time off and paid holidays; wellness and transportation benefits.
Application instructions:
- “Take the leap and apply today.”