JT223 - VALIDATION SPECIALIST

Jayuya, Puerto Rico
Temporary
Medical Device
Mid Level

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

Responsibilities:

  • Responsible for technical support and the overall management of Vision System Integration and/or Manufacturing Equipment Modifications Validation Program at a facility.
  • Provides technical and project leadership over Vision System Integration and/or Manufacturing Equipment Modification validation in support of company projects, support of manufacturing operations and for eventual release testing of intermediate and finished products.
  • Develop test method qualification and validation protocols for Vision System Integration and/or Manufacturing Equipment Modifications.
  • Ensure validation master plans comply with Clients and regulatory agency requirements.
  • Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
  • Support continuous improvement within the validation department.
  • Support regulatory submissions and regulatory agency inspections as required Represent Baxter validation department to industry as required.
  • validate printing equipment due to a change in material

Qualifications:

  • Bachelor's Degree in Engineering or Science
  • 2+ years related experience or demonstrated performance within a GMP regulated environment within the pharmaceutical industry. 
  • Ability to work effectively with multi-department and multi-site teams.
  • Ability to manage and organize complex technical problems.
  • Good written and oral communication skills, excellent attention to details.
  • Strong team leader with project management skills and focus on results.
  • Availability for 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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