Automation Validation Specialist

1 week ago


Lebanon, New Hampshire, United States Pharmavise Corporation Full time

Overview

We are a regulatory compliance consulting firm, Pharmavise Corporation, partnering with Pharmaceutical, Medical Device and Biotechnology clients. Our mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

Our Fortune 500 Pharmaceutical client has an exciting opportunity for an Automation Validation Specialist (Regulated Equipment) in Lebanon, Indiana.

We are seeking a skilled Regulated Equipment Engineer to support complex manufacturing projects in regulated environments. The ideal candidate will ensure equipment and automation systems meet compliance standards and operate effectively within Good Manufacturing Practice (GMP) guidelines.

Key Responsibilities:

  • Coordinate, develop and maintain validation deliverables per the project requirements
  • Gather and write technical data from SMEs, assembly drawings, resource documents, and by observing manufacturing equipment
  • Participate in testing as assigned by the C&Q Lead
  • Assist in gathering data for C&Q process metrics as assigned by the C&Q Lead
  • Review and approve coordination plans, design, and testing documentation

Salary Range: $80,000 - $110,000 per year based on experience.

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)

This position requires strong document management and technical writing skills, as well as proficiency in Microsoft software such as Word and Excel. Experience of working within a schedule-driven environment is essential. Travel may be required internationally and domestically for design reviews and Factory Acceptance Testing (FAT) activities.


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