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JT727 - VALIDATION SPECIALIST

Quality Consulting Group · Villalba, Vereinigte Staaten Von Amerika · Onsite

  • Professional
  • Optionales Büro in Villalba
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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:
  • Evaluate the impact of validated computerized systems on existing work instructions and processes.
  • Prepare and execute computer system validation protocols and generate comprehensive reports.
  • Develop and maintain Installation Qualification (IQ) documentation.
  • Collaborate with process owners to implement changes to work instructions and ensure compliance.
  • Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
  • Ensure adherence to company procedures, quality system regulations, and industry standards.
  • Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.
  • Organize and track project progress, maintaining detailed documentation and status updates.
  • Contribute to cross-functional projects and support milestone completion.
  • Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.
Qualifications: 
  • Bachelor’s degree in Engineering
  • Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
  • Practical knowledge and demonstrated competence in validation and quality systems
  • Investigation and root cause analysis skills
  • Technical writing knowledge
  • Organization and Communication skills
  • Process Validation and Computer software validation knowledge
  • Experience in SDLC
  • Experience in medical devices or other highly regulated industry (e.g., medical devices, pharmaceuticals, biotech)
  • Excellent verbal and written communication skills in both English and Spanish
  • Availability to work 1st shift