Our Client is seeking a driven Validation Specialist in Marion, NC to help redefine healthcare and save and sustain lives. In this role, you will validate cutting-edge medical device and pharma operations by leveraging your expertise in Kneat Gx, FDA regulations, and ISO 13485 standards.
location: Marion, North Carolina
job type: Contract
salary: $34.98 - 52.47 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform hands-on IQ, OQ, PQ, and requalification activities for manufacturing equipment, utilities, and computerized systems using risk-based methodologies.
- Author, route, and manage validation documentation strictly within KNEAT Gx, ensuring end-to-end traceability and 21 CFR Part 11 data integrity compliance.
- Guarantee all deliverables meet FDA cGMP, ISO 13485, and internal QMS standards to maintain a state of continuous inspection and audit readiness.
- Investigate validation deviations, assess change control impacts, and drive root cause analysis to maintain system integrity.
- Partner with Engineering, Quality, IT, and Operations to provide dynamic on-floor support for commissioning, 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.
