Looking for a Validation Specialist in Marion, NC. Requires FDA, ISO, cGMP & Kneat Gx expertise. Join Our Client, a pioneering healthcare leader with a 90-year legacy, uniting to save and sustain lives through innovative, connected care solutions. Redefine healthcare with us!
location: Marion, North Carolina
job type: Contract
salary: $30.74 - 49.19 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform hands-on IQ, OQ, PQ, and requalification for manufacturing equipment, utilities, and computerized systems using risk-based GAMP 5 methodologies.
- Author, route, and maintain end-to-end traceability of validation documentation within Kneat Gx, ensuring full compliance with 21 CFR Part 11 and data integrity expectations.
- Maintain audit-ready validation deliverables that strictly adhere to FDA cGMP regulations, ISO 13485 standards, and internal Quality Management Systems.
- Investigate validation deviations directly within Kneat Gx, conduct root cause analyses, and support system impact assessments for change controls.
- Collaborate with Engineering, IT, Quality, and Operations to deliver on-floor support during commissioning, troubleshooting, line upgrades, and new equipment introductions.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
