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Senior Validation Specialist

Job

Chipton-Ross

Marion, NC (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 7/22/2026

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Job Description

Chipton-Ross is seeking a Senior Validation Specialist for a contract opportunity in Marion, NC.
BASIC QUALIFICATIONS
(REQUIRED
SKILLS/EXPERIENCE
):
  • Detail oriented with a strong compliance mindset
  • Ability to work independently under contract deliverables
  • Strong problem solving and root cause analysis skills
  • Effective communication with cross functional teams
  • Comfortable working in production and controlled environments
POSITION RESPONSIBILITIES
  • Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharma and medical device manufacturing systems.
  • Support validation of:
  • Manufacturing and packaging equipment
  • Utilities (compressed air, clean utilities, environmental controls)
  • Computerized systems (automation, data acquisition, MES, LIMS, vision systems)
  • Apply risk based validation methodologies aligned with GAMP 5 and industry best practices.
  • Author, execute, review, and route validation documents within KNEAT Gx.
  • Maintain end to end traceability between:
  • User Requirements (URS)
  • Risk Assessments
  • Test cases and protocols
  • Deviations and final reports
  • Ensure proper use of KNEAT Gx workflows, execution controls, and electronic approvals.
  • Maintain compliance with 21 CFR Part 11 and data integrity expectations.
PREFERRED QUALIFICATIONS
(DESIRED
SKILLS/EXPERIENCE
):
  • Experience supporting medical device manufacturing under
ISO 13485.
  • Experience with automation and controls (PLC/SCADA), vision systems, or MES.
  • Experience supporting high speed packaging or assembly lines.
  • Exposure to validation remediation or regulatory commitment work.
REQUIRED EDUCATION
  • Accredited
HSD/GED WORK HOURS
  • Full-Time
  • 1st Shift