Validation Engineer

Senior / Mid-Level Validation Engineer
Locations: Boston, MA
Duration: 4 6 months, strong possibility of extension
Rate:$41.60 $56.80/hr W2
Work Arrangement: Onsite

Position Overview
Seeking Validation Engineers to support requalification and revalidation activities across manufacturing equipment, facilities, utilities, and processes within a regulated pharmaceutical/biotech environment.

Responsibilities

• Author and execute validation/revalidation protocols.
• Support equipment, facility, utility, and process requalification.
• Perform validation gap assessments and impact assessments.
• Review test results and investigate discrepancies.
• Prepare validation reports and inspection-ready documentation.
• Support change controls, risk assessments, and remediation activities.
• Collaborate with QA, Engineering, and Manufacturing teams.
• Ensure compliance with FDA, cGMP, and internal procedures.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years of validation experience; 10+ years preferred for Senior level.
• Hands-on experience authoring and executing validation protocols.
• Experience with equipment, facility, utility, and/or process validation.
• Strong understanding of cGMP and FDA requirements.
• Strong technical documentation and communication skills.
• Pharmaceutical, biotech, sterile, or aseptic manufacturing experience preferred.
• CQV, lifecycle validation, and risk-based validation experience is a plus.