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Validation Engineer
Tampa, FL, US
Engineering
Unspecified
Full Time, Temporary
$60.00-$90.00/HR
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Tampa, FL, US
$60.00-$90.00/HR
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Unspecified
First Shift (Day)
Job details
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.
10436095
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