Validation Engineering

Contract Validation Engineer – MS Prime Implementation
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.

Develop, review, and execute validation lifecycle deliverables, including requirements, specifications, risk assessments, traceability matrices, qualification protocols, and validation reports.
Support IQ/OQ/PQ planning, execution, discrepancy resolution, and final reporting activities.
Partner with Microbiology, Quality, IT, and Vendor teams to ensure compliance and timely project execution.
Participate in project meetings, working sessions, and cross-functional planning activities.
Identify project risks, compliance gaps, and mitigation actions.

5+ years of Validation experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.

• Strong working knowledge of IQ/OQ/PQ, risk assessments, change control, and validation documentation.
• Experience supporting Microbiology laboratory operations and instrument implementations preferred.
• Ability to work independently in a fast-paced, project-driven environment.

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

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

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