Senior Validation Specialist

Job Description

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