Validation Engineer

Contract Validation Engineer – MS Prime Implementation

Position: Contract Validation Engineer / Validation Specialist

Project Overview

Support the implementation and qualification of the bioMérieux VITEK® MS Prime system within a GMP-regulated Microbiology laboratory. This is a high-priority FDA remediation project with an aggressive implementation timeline through Q1 2027.

Primary Responsibilities

• Develop, review, and execute validation lifecycle deliverables, including requirements, specifications, risk assessments, traceability matrices, qualification protocols, and validation reports.
  
• Review vendor qualification and lifecycle documentation and perform gap assessments.
  
• Support IQ/OQ/PQ planning, execution, discrepancy resolution, and final reporting activities.
  
• Support change controls, deviations, impact assessments, and release-for-use activities.
  
• Partner with Microbiology, Quality, IT, and Vendor teams to ensure compliance and timely project execution.
  
• Support SOP and Work Instruction development and updates.
  
• Participate in project meetings, working sessions, and cross-functional planning activities.
  
• Identify project risks, compliance gaps, and mitigation actions.

Required Qualifications

• 5+ years of Validation experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
  
• Experience with laboratory instrument qualification and computerized systems validation (CSV/CSA).
  
• Strong working knowledge of IQ/OQ/PQ, risk assessments, change control, and validation documentation.
  
• Experience supporting Microbiology laboratory operations and instrument implementations preferred.
  
• Experience with bioMérieux systems, MALDI-TOF technology, or VITEK® MS Prime is highly desirable.
  
• Ability to work independently in a fast-paced, project-driven environment.

Assignment Focus

• Validation document development and review
  
• Qualification and testing support
  
• Project coordination, meetings, and issue resolution

Duration

Temporary contract assignment supporting implementation, qualification, and release activities through project completion in Q1 2027-Project has potential to be extended

Priority

Immediate need to support a critical FDA remediation initiative and accelerated implementation timeline.