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Validation Engineer

  • Portland, ME
  • This position has been filled

The Validation Engineer is a dynamic role contributing to developing new products, systems and processes used in manufacturing, testing or quality systems. Establish user requirements, write and execute validation plans, protocols, and reports.

RESPONSIBILITIES:

  • Act as the Subject Matter Expert for validations within the operations team.
  • Implementation of innovative systems and development of activities for compliance with validation principles, federal regulations, guidelines and company policy.
  • Analyze and improve on company validation procedures and practices.
  • Assess validation requirements for projects and programs. Write reports and follow-up on recommendations to assure that necessary changes are made to existing systems and procedures.
  • Review and troubleshoot anomalies, deviations, etc.
  • Resolve and consult on complex issues.
  • Ensure accuracy and completeness of validation records.
  • Align operations documents to facilitate manufacturing, logistical and QA processes.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company‚Äôs policies and practices.

QUALIFICATIONS

  • BS in Engineering, Life Science or other relevant field of study
  • Process validation experience in a regulated industry; medical device preferred
  • Excellent quantitative and analytical skills including proficient use of statistical software
  • Ability to communicate comfortably with confidence to cross-functionally collaborate
  • Strong project management and problem-solving skills.

Long-Term Project/Contract