Validation Engineer / Validation Specialist

Location: Maryland
Duration: Long-Term Contract

About the role

We are seeking an experienced Validation Engineer/Validation Specialist to support equipment, utilities, and facility qualification activities in a GMP-regulated pharmaceutical/biotechnology manufacturing environment. The ideal candidate will have hands-on experience executing validation protocols and supporting commissioning, qualification, and compliance initiatives.

Responsibilities

• Develop, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for manufacturing equipment and utilities.
• Prepare validation reports, SOPs, risk assessments, gap analyses, and technical documentation following GDP and cGMP requirements.
• Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
• Analyze validation data and investigate deviations to ensure compliance with acceptance criteria.
• Support commissioning, FAT/SAT, equipment startup, and qualification activities.
• Assist with audits and provide technical support for manufacturing and validation investigations.
• Review validation documentation and collaborate with Engineering, Manufacturing, Quality, and Maintenance teams.

Requirements

• Bachelor's degree in Engineering or a related scientific discipline with 4+ years of validation experience, or 8+ years of relevant validation experience without a degree.
• Hands-on experience in GMP pharmaceutical or biotechnology manufacturing.
• Strong knowledge of IQ/OQ/PQ, cGMP, GDP, and validation lifecycle.
• Experience with aseptic processing, cleanrooms, sterilization equipment, and critical utilities (HVAC, WFI, RO, compressed air, etc.).
• Familiarity with Kaye AVS, Veriteq, EDMS, LIMS, Microsoft Office, and related validation systems.
• Excellent troubleshooting, documentation, and communication skills.
• Ability to manage multiple projects independently and in a team environment.