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Validation Specialist

2 months ago


Lebanon, New Hampshire, United States Pharmavise Corporation Full time

Job Summary

We are seeking a highly skilled Validation Engineer (Automation) to join our team at Pharmavise Corporation. As a key member of our regulatory compliance team, you will be responsible for ensuring equipment and automation systems meet compliance standards and operate effectively within Good Manufacturing Practice (GMP) guidelines.

Key Responsibilities

  1. Coordinate, develop and maintain validation deliverables per project requirements
  2. Participate in testing as assigned by the C&Q Lead
  3. Review and approve coordination plans, design, and testing documentation
  4. Document upload and control of deliverables within Kneat
  5. Upload and management of C&Q related deliverables within the Project database

Requirements

  • 5 years of experience as a Validation Engineer (Automation) in the Pharmaceutical Industry with experience in Commissioning and Qualification (C&Q)
  • Proficiency in equipment and automation validation as applied in a GMP regulated area
  • Bachelor's degree in Engineering, Biomedical Engineering, or another closely related field in the Life Sciences
  • Strong knowledge of external validation standards (e.g., GAMP, ISPE, ICH)

Travel Requirements

  • Ability to travel internationally and domestically to Original Equipment Manufacturers (OEM) for design reviews and Factory Acceptance Testing (FAT) activities
  • Ability to travel internationally and travel to RS/CM for Site Acceptance Testing (SAT) activities