Senior Validation Specialist

hace 15 horas

Carolina, Carolina, Puerto Rico Mentor Technical Group A tiempo completo

Job Description

Mentor Technical Group seeks a highly skilled Sr. Validation Specialist to join our team. As a member of our technical group, you will be responsible for ensuring the validation of computer systems and processes meets industry standards.

About the Role

This position requires excellent verbal communication and technical writing skills. Proficiency in Microsoft Office applications is necessary, including Word, Excel, PowerPoint, and Project.

Responsibilities

  • Development and execution of system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
  • Validation of complex computer systems (e.g., multiple GAMP classes of systems)
  • Development of Installation, Operational, and Performance qualification documents
  • Creation of Validation Master Plans for simple systems or facilities
  • Project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems)
  • Troubleshooting and maintenance of computer systems
  • Effective written and oral communication skills

Requirements

  • Bachelor's degree in scientific or engineering discipline
  • At least 5 years of experience in computer validation
  • Excellent verbal communication and technical writing skills
  • Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Project)
  • Familiarity with industry best practices (e.g., ISPE GAMP)

Benefits

Mentor Technical Group offers a competitive salary and benefits package, including opportunities for professional growth and development.

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