Process Validation Engineer

Redmond, WA

Description

The project is onsite for 9 months in Redmond, WA. Please let me know if you have anyone that fits this profile (please ensure we receive great candidates with prior PV experience) .

Key Responsibilities:

Author, review, and execute process validation protocols and reports, including but not limited to media fills, PPQ (Process Performance Qualification), and chemical hold studies.

Conduct risk assessments and support validation strategy development in compliance with regulatory guidelines (e.g., FDA, EMA, ICH).

Analyze validation data, troubleshoot issues, and recommend process improvements.

Collaborate cross-functionally with manufacturing, quality assurance, and regulatory teams to ensure robust process validations.

Maintain comprehensive and compliant validation documentation.

Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or a related field.

5-7 years of hands-on experience in process validation within a pharmaceutical or biotech environment.

Strong knowledge of cGMP, FDA/EMA guidelines, and industry best practices.

Excellent technical writing skills and attention to detail.

Proven ability to manage multiple projects and meet deadlines in a fast-paced environment.