Biotech Validation Engineer – GMP IQ/OQ/PQ (Contract)

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

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.