GxP Quality Assurance Engineer

5 days ago


Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time
Join Our Team

White Collar Technologies is a leading consultancy firm specializing in IT and engineering consulting for the life science sector. We are committed to providing top-notch services and creating innovative solutions that drive growth and success for our clients.

We are seeking an experienced Validation Engineer/Analyst to join our dynamic team. As a key member of our team, you will be responsible for ensuring compliance with GxP regulations and maintaining high-quality standards in instrument validation.

Key Responsibilities:

  • Authoring and revising validation plans, protocols, and reports
  • Performing GxP-related activities, such as risk assessments and deviation resolution
  • Liaising with vendors and managing documentation
  • Mentoring junior team members and promoting cross-functional collaboration
  • Staying up-to-date with industry developments and best practices

Requirements:

  • Minimum 5 years' experience in validation, preferably in biotech/pharmaceutical environments
  • Excellent working knowledge of process automation, computer system validation concepts, and GAMP methodologies
  • Bachelor's degree in Engineering, Life Science, or Computer Science required

What We Offer:

  • A competitive salary range: $95,000 - $120,000 per annum
  • Ongoing professional development opportunities
  • Collaborative work environment
  • Comprehensive benefits package, including medical, dental, and vision coverage


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