Validation Engineer III

1 day ago


Windsor, Colorado, United States TOLMAR Full time
Job Title: Validation Engineer III

At Tolmar, we are seeking a highly skilled and experienced Validation Engineer III to join our team. As a key member of our Validation department, you will be responsible for leading the development and execution of commissioning, qualification, and validation activities for our manufacturing support facilities, utilities, systems, and equipment.

Key Responsibilities:
  • Lead change management and impact assessments of validated processes and equipment.
  • Develop and maintain site and project validation plans.
  • Follow and maintain FUSE re-qualification schedules and activities.
  • Support and lead commissioning, qualification, and validation activities with cross-functional teams.
  • Lead Quality Management Systems activities, including CAPAS, Change Actions, Deviations, Risk Assessments, and Root Cause Analysis.
  • Support inspections during internal and external audits.
  • Develop, review, and approve cycle development initiatives and activities.
  • Generate protocols and execute qualification activities.
  • Participate in required annual hazardous waste training.
Requirements:
  • Bachelor's degree in engineering or science-related field.
  • Minimum of 5 years of experience in the pharmaceutical industry with a minimum of 3 years of Validation experience.
  • In-depth knowledge of current validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.
  • Experience in Statistical Analysis a plus.
What We Offer:
  • Annual pay range $95,000 - $105,000.
  • Bonus eligible.
  • Relocation benefits available.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation, or any other applicable status protected by state or local law.


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