Senior Validation Specialist

RESPONSIBILITIES:
Kforce has a client that is seeking a Senior Validation Specialist in Deerfield, IL.

Key Tasks:
* Execute validation activities including IQ, OQ, PQ, requalification, and validation maintenance
* Support validation of manufacturing and packaging equipment, utilities, and computerized systems (e.g., automation, MES, LIMS, vision systems)
* Author, execute, and manage validation documentation using Kneat Gx
* Maintain end-to-end traceability across URS, risk assessments, protocols, deviations, and final reports
* Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices
* Ensure compliance with FDA cGMP, 21 CFR Part 11, and ISO 13485 requirements
* Support deviation investigations, change control assessments, and CAPA activities
* Collaborate cross-functionally with Engineering, Quality, Automation, IT, and Operations
* Support audits, inspections, and continuous inspection readiness initiatives

REQUIREMENTS:
* Proven experience executing validation in pharmaceutical or medical device manufacturing environments
* Strong working knowledge of cGMP, FDA regulations, and data integrity requirements
* Hands-on experience with Kneat Gx or similar electronic validation systems
* Experience validating equipment, utilities, and/or computerized systems
* Strong documentation, problem-solving, and cross-functional communication skills
* Ability to work independently in a fast-paced, regulated production environment

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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