Validation Engineer

Position:
Contract Validation Engineer / Validation Specialist

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.
• 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.

• 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.

• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Please note:

The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.  () for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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