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.