Senior Validation Specialist

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
 
Job Number: 218742
Job Location: Marion, NC
Rate: Up to $61.48 DOE
Duration: 12 months
Input Date: 06/19/2026
Firm Name: CHIPTON ROSS
Attention: Billy James
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: bjames@chiptonross.com
Website: www.chiptonross.com
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