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
- DurationTemporary contract assignment supporting implementation, qualification, and release activities through project completion in Q1 2027-Project has potential to be extended
- PriorityImmediate need to support a critical FDA remediation initiative and accelerated implementation timeline.
