Validation Specialist

Job Purpose

The Validation Specialist will support GMP quality control laboratory activities within a microbiology laboratory environment. This role combines hands‑on microbiological testing with execution and maintenance of equipment, process, and analytical method validations. This is a bench‑based role requiring daily work in a microbiology laboratory (e.g. culture handling, plating, microbial enumeration, environmental monitoring) in addition to validation documentation responsibilities. The position is execution‑focused and requires strong technical laboratory competency.

• Perform routine microbiological testing in a GMP QC Laboratory, including but not limited to:
  • Microbial plating and enumeration
  • Culture handling and propagation
  • Media preparation
  • Environmental monitoring
  • Aseptic technique and biosafety practices
• Execute analytical method testing in accordance with approved SOPs and specifications
• Assist with laboratory investigations, OOS/OOT events, and corrective actions.
• Maintain laboratory equipment, calibration, and documentation.
• Ensure compliance with GMP, GLP, safety, and quality system requirements.

• Execute and document equipment, process and analytical method validations (IQ/OQ/PQ) in accordance with GMP requirements.
• Author and revise validation protocols, reports, and supporting documentation.
• Support risk‑based validation activities and change control assessments.
• Maintain validation files and ensure validation status is current and audit‑ready.
• Support investigations, deviations, and CAPAs related to validation and QC activities.
• Partner with QA, Engineering, and Production to support validation activities associated with new equipment, process changes, and continuous improvement initiatives.
• Provide validation support during internal and external audits.

• Bachelor’s degree in Microbiology, Biology, or Chemistry.
• 3+ years experience in GMP environment (biotech, animal health, pharmaceuticals, or related).
• Hands‑on experience executing validation activities (equipment, process, or method validation).
• Working knowledge of GMP documentation, change control, deviations, and CAPA.
• Strong attention to detail and ability to manage documentation‑heavy workflows.
• Comfortable working in a small‑to‑mid‑size manufacturing environment with evolving priorities.

• Supporting audits and regulatory inspections.
• Experience in animal health, fermentation, or biotechnology manufacturing environments.
• Developing, writing, and executing validation protocols in a GMP environment.
• Prior experience in a microbiology‑focused QC laboratory