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Validation Engineer

Job
Validation Engineer
Location
Woburn, MA
Employment Type
Full Time
Starting
ASAP
Required qualifications
  • BS degree in life sciences or related engineering discipline
  • A minimum of 5-8 years of direct validation experience within the life sciences industry and cGMP environments
  • Effective written and oral communication skills
  • Ability to manage multiple projects, create and work within internal timelines, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
  • Exceptional proficiency in Good Documentation Practices (GDP)
  • Knowledge of cGMP, 21 CFR 210, 211, and Part 11, and the International Council for Harmonisation (ICH), ASTM E2500, ISPE Baseline Guide Vol. 5 for C&Q, GAMP 5, and United States Pharmacopeia (USP) guidelines
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