Computer System Validation (CSV) Specialist

CencoraPuerto Rico, TX
1dOnsite

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Responsible for the MES Support and validation services. Primary focused on Syncade recipe configuration and validation. For this opportunity the resource will be working collaboratively with cross-functional teams including Manufacturing, Quality, Automation, and IT to ensure systems are configured, tested, and maintained in compliance with GMP and Computer System Validation (CSV) requirements.

Requirements

  • 5+ years of experience in CSV in regulated environments
  • 3+ years of hands-on experience with MES platforms, preferably Emerson Syncade, including development and maintenance of BI solutions.
  • Computer systems integrations and validation experience in regulated operations (preferably GMP operations).
  • Strong experience authoring and executing validation documentation (test scripts, protocols, reports).
  • Excellent technical and quality documentation skills in English, including validation deliverables and test evidence.
  • Able to use a logical, systematic approach to problem solving.
  • Ability to manage multiple priorities and work independently with limited supervision.
  • Strong communication, teamwork and collaboration skills.

Responsibilities

  • Supporting Syncade recipe configuration and maintenance, version control, and lifecycle management (e.g., Recipe Authoring, Equipment Tracking, Material Management, Workflow, Inventory)
  • Configure and maintain MES modules and workflows, ensuring alignment with site and global standards.
  • Configure and support MES integrations with ERP and automation systems (e.g., SAP, DCS, middleware).
  • Provide configuration-level troubleshooting and support root cause analysis for MES-related issues.
  • Execute and support CSV deliverables associated with Syncade configuration changes, including but not limited to: Risk assessments, URS / FRS reviews, test plans and test scripts, and IQ / OQ / PQ execution and summary reports.
  • Prepare and ensure validation documentation complies with GMP, CSV, and ALCOA+ data integrity principles.
  • Support change control impact assessments, deviations, and CAPA activities related to MES.
  • Support data validation and reconciliation activities for MES-related reports.
  • Participate in project meetings, design reviews, and deployment activities.

Benefits

  • In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.
  • This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
  • To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
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