Title: Validation Specialist
Location: Marion, NC 28752 (Onsite)
Duration: 12 Months (Contract)
Shift: Monday to Friday
Payrate: $45 to $57/hr on W2 (depending on experience)
Description:
- The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system.
- This role is focused on hands on execution of validation deliverables to support equipment, process, utility, and computerized system readiness in accordance with FDA, ISO, and cGMP requirements.
- The specialist will work closely with Engineering, Quality, Automation, IT, and Operations to ensure systems and equipment are validated, audit ready, and capable of supporting safe, compliant production.
Key Responsibilities:
- Validation Execution (Primary Role)
- 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.
KNEAT Gx Lifecycle Management:
- 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.
Deviation, Change Control & CAPA Support:
- Document and investigate validation deviations within KNEAT Gx.
- Support change control impact assessments affecting validated systems.
- Participate in root cause analysis and CAPA implementation when required.
Regulatory & Quality Compliance:
- Ensure validation deliverables comply with:
- FDA cGMP regulations (21 CFR Parts 210/211, Part 11)
- ISO 13485 (Medical Devices)
- Internal Quality Management System (QMS) requirements
- Support regulatory inspections and customer audits by providing validation documentation and responses.
- Maintain validation documentation in a state of continuous inspection readiness.
Cross Functional Support:
- Collaborate with Engineering, Quality, IT, Automation, Manufacturing, and external vendors.
- Provide on floor support during commissioning, troubleshooting, and validation execution.
- Support site initiatives such as new equipment introduction, line upgrades, remediation efforts, and capacity expansions.
Preferred Qualifications:
- 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.
Core Competencies:
- 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
Work Conditions:
- On site support in a controlled GMP manufacturing environment
- May require off shift or weekend support during execution windows
- PPE and gowning requirements may apply depending on area
