Validation Engineer

QCS Staffing; Seattle (WA); On-site; USD 80,000 - 100,000; Full time

Job summary

A global biotechnology organisation is seeking a Validation Engineer for a 4-6 month contract in Seattle. The role involves implementing safety requirements and maintaining validated status for a new therapeutic protein production facility. Ideal candidates will have experience in regulated GMP environments and a strong understanding of validation principles. Attention to detail and familiarity with regulatory guidelines are essential. Apply now to be part of this critical project in expanding biotech operations.

Qualifications

• Experience in pharmaceutical, biotech, or regulated GMP environments.
• Strong understanding of validation principles, equipment qualification, and process validation.
• Familiarity with regulatory guidelines like EU GMP Annex 15 and FDA 21 CFR Parts 210/211.

Responsibilities

• Identify gaps, risks, and improvement opportunities.
• Support the maintenance of validated status through impact assessments.
• Maintain validation files and ensure documentation is audit-ready.

Skills

Experience in pharmaceutical, biotech, or other regulated GMP environments

Strong understanding of validation principles (IQ/OQ/PQ)

Excellent analytical and documentation skills

Job description

Overview

Validation Engineer - Redmond, Seattle - 4-6 Month Contract
Our client, a global biotechnology organisation, is recruiting for a Validation Engineer to join their capital project in Redmond. This new build facility will house a therapeutic protein production plant, and we are looking for a Validation Engineer to help expand our client's biotech operations throughout Europe. As the Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.

What You’ll Do

• Identify gaps, risks, and improvement opportunities, escalating issues where required.
• Support the maintenance of validated status through impact assessments, requalification planning, and validation updates.
• Maintain validation files and ensure documentation is audit-ready at all times.
• Participate in internal and external audits, providing subject-matter expertise on validation lifecycle and periodic review processes.

What you’ll need

• Experience in pharmaceutical, biotech, or other regulated GMP environments.
• Strong understanding of validation principles (IQ/OQ/PQ), equipment qualification, and process validation.
• Familiarity with regulatory guidelines including EU GMP Annex 15, FDA 21 CFR Parts 210/211, and data integrity expectations.
• Excellent analytical and documentation skills with a high attention to detail.

If this role is of interest, please apply now!