Validation Engineer / Validation Specialist

Location: Maryland
Duration: Long Term

About the role

We are seeking an experienced Validation Engineer / Validation Specialist to support equipment, utility, and process qualification activities within a GMP pharmaceutical/biotechnology manufacturing environment. The ideal candidate will prepare and execute IQ, OQ, PQ, and Requalification (RQ) protocols, generate validation reports, develop technical documentation, and ensure compliance with cGMP and Good Documentation Practices (GDP).

Responsibilities

• Prepare, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for equipment and utilities.
• Generate qualification reports, SOPs, specifications, methods, and other validation documentation.
• Develop acceptance criteria based on industry standards, manufacturer recommendations, user requirements, and cGMP guidelines.
• Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
• Analyze validation data and verify compliance with acceptance criteria.
• Investigate, document, and resolve deviations associated with qualification studies.
• Support commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Prepare technical reports, gap assessments, and risk assessments.
• Provide technical support for troubleshooting manufacturing equipment and systems.
• Perform technical reviews of qualification documents.
• Support internal and external audit readiness activities.

Requirements

• Bachelor's degree in Engineering or a related scientific discipline with a minimum of 4 years of validation experience, or 8+ years of relevant validation experience in lieu of a degree.
• Experience working in GMP pharmaceutical or biotechnology manufacturing environments.
• Hands-on experience with Equipment Qualification (IQ/OQ/PQ/RQ) activities.
• Knowledge of cGMP regulations and Good Documentation Practices (GDP).
• Experience with aseptic manufacturing processes.
• Familiarity with Kaye AVS or Veriteq thermal mapping systems.
• Working knowledge of cleanrooms, sterilization equipment, HVAC, WFI, RO, CCA, computerized systems, and isolator technology.
• Experience with Microsoft Office, EDMS, LIMS, and related documentation systems.
• Strong technical writing, communication, organizational, and project management skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Knowledge of maintenance and calibration procedures is preferred.