Job Description Job #218742
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 EDUCATIONWORK HOURSADDITIONAL INFORMATION - Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
For more information, please apply or contact:
Billy James 800.927.9318 x340
[email protected] 
