Lead Validation Engineer, Cleaning & Shipping

Evotec WD

Redmond (WA)

On-site

USD 115,000 - 127,000

Full time

7 days ago

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Benefits offered by this job

Discretionary annual bonus

Medical, Dental & Vision

Disability insurance

Life insurance

401k match

Flexible work

Paid time off

Wellness benefits

Transportation benefits

Job summary

Just - Evotec Biologics in Redmond, WA is seeking a Validation Engineer III to lead cleaning validation strategies for late-stage and commercial biologics manufacturing. You will develop and execute validation documents and work across CQV with Operations, Quality, Tech Transfer and external partners.

This role requires 7+ years in GMP pharmaceutical or biologics environments, strong problem-solving, and knowledge of FDA CFRs/ICH.

Qualifications

Bachelor’s degree in engineering science or related field.
7+ years of relevant experience in validation within GMP pharma/biologics.
Strong knowledge of cleaning validation and risk-based approaches.

Responsibilities

Lead development and execution of phase-appropriate validation deliverables for cleaning and CQV.
Develop Validation Master Plans and supporting documentation.
Coordinate with cross-functional teams and external contractors to plan cycle development, qualification and validation activities.
Author validation documentation including risk assessments, protocols, reports, and discrepancies.
Lead validation discrepancy resolution and root cause analysis.