Senior Validation Engineer: Cleaning & Shipping CQV

Life Science Washington; Redmond (WA); On-site; USD 115,000 - 127,000; Full time

Benefits offered by this job

Medical and dental benefits

401k with company match

Paid time off

Job summary

Just-Evotec is seeking a Validation Engineer III to lead cleaning, shipping and process validation activities for late phase and commercial biologics manufacturing. You will design validation programs, generate master plans, and coordinate with equipment, operations, QC/Analytical, tech transfer and third parties.

The role emphasizes global CQV strategy, risk-based approaches, and progressing digital validation tools while supporting audits and inspections in a fast-paced environment.

Qualifications

• Bachelor's degree in engineering with 7+ years in validation.
• Experience with US FDA CFRs and European EMA including ICH regulations.
• Expert knowledge of cleaning and shipping.
• Experience with quality risk management.
• Experience authoring, reviewing, and approving validation documentation.
• Knowledge of process equipment, utilities, operations, and engineering principles.

Responsibilities

• Lead generation of key deliverables in a phase-appropriate compliance manner as part of global CQV strategy for F/U, Equipment, QC/Analytical, Cleaning and Shipping.
• Document a strategy for validations programs including the generation of validation master plans.
• Liaise with cross-functional teams to define and perform cycle development, qualification and validation activities.
• Author validation documentation including risk assessments, cycle development protocols/reports, validation protocols and reports.
• Lead validation discrepancy resolution including troubleshooting and root cause analysis.
• Support digital validation software transition to globally scalable end-to-end paperless solutions.
• Develop compliant and novel ways to satisfy regulatory requirements.
• Support inspection readiness activities and audits; assist with corrective actions.
• Lead CQV activities across global expansion sites.

Skills

CQV strategy

Validation master plans

Regulatory alignment

Root cause analysis

Documentation writing

Team collaboration

Troubleshooting

Education

Bachelor's degree in engineering

Tools

Digital validation software

Job description

Just-Evotec is seeking a Validation Engineer III to lead cleaning, shipping and process validation activities for late phase and commercial biologics manufacturing. You will design validation programs, generate master plans, and coordinate with equipment, operations, QC/Analytical, tech transfer and third parties.

The role emphasizes global CQV strategy, risk-based approaches, and progressing digital validation tools while supporting audits and inspections in a fast-paced environment.