Engineering Specialist

Cencora-posted 3 months ago
Full-time • Entry Level
Villalba, PR
5,001-10,000 employees
Merchant Wholesalers, Nondurable Goods
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We are seeking a Validation Specialist to support the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.

  • Valuate 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
  • Engineering degree
  • Hands-on experience in Process and Computerized Systems Validation
  • Background in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)
  • Excellent verbal and written communication skills in both English and Spanish
  • Practical knowledge and demonstrated competence in validation and quality systems
  • Medical, dental, and vision care
  • Backup dependent care
  • Adoption assistance
  • Infertility coverage
  • Family building support
  • Behavioral health solutions
  • Paid parental leave
  • Paid caregiver leave
  • Training programs
  • Professional development resources
  • Opportunities to participate in mentorship programs
  • Employee resource groups
  • Volunteer activities
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