Job title: Sr. Validation Specialist
Location: Marion,NC — Onsite
Contract Duration: 1 Year
ROLE OVERVIEW
We are seeking an experienced Sr. Validation Specialist with hands-on KNEAT Gx expertise to support pharmaceutical and medical device manufacturing operations. In this role, you will execute and maintain compliant validation activities using KNEAT Gx as the electronic validation lifecycle management system — ensuring equipment, processes, utilities, and computerized systems are validated, audit-ready, and capable of supporting safe, compliant production.
This is a hands-on execution role — ideal for a detail-oriented validation professional who thrives in a regulated GMP manufacturing environment and brings deep experience with IQ/OQ/PQ protocols, 21 CFR Part 11, and GAMP 5 methodologies.
You will collaborate closely with Engineering, Quality, Automation, IT, and Operations teams to drive validation deliverables across a high-volume manufacturing site.
KEY RESPONSIBILITIES
- Validation Execution — Primary Focus
- 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), and computerized systems (automation, data acquisition, MES, LIMS, vision systems)
- Apply risk-based validation methodologies aligned with GAMP 5 and current industry best practices
- Provide on-floor support during commissioning, troubleshooting, and validation execution windows
- 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 full compliance with 21 CFR Part 11 and data integrity expectations throughout the validation lifecycle
- 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 as required
Regulatory & Quality Compliance
- Ensure all validation deliverables comply with FDA cGMP regulations (21 CFR Parts 210/211, Part 11), ISO 13485, and internal 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 Collaboration
- Work closely with Engineering, Quality, IT, Automation, Manufacturing, and external vendors
- Support site initiatives including new equipment introduction, line upgrades, remediation efforts, and capacity expansions
REQUIRED QUALIFICATIONS
- Hands-on experience with KNEAT Gx — authoring, executing, reviewing, and routing validation documents — required
- Demonstrated experience executing IQ, OQ, and PQ protocols in a pharmaceutical or medical device manufacturing environment
- Strong working knowledge of 21 CFR Parts 210/211 and Part 11
- Applied experience with GAMP 5 risk-based validation methodology
- Experience with deviation management, change control, and CAPA processes
- Familiarity with validation of computerized systems — automation, MES, LIMS, or similar
- Comfortable working on the production floor in a controlled GMP manufacturing environment
- Strong attention to detail with a compliance-first mindset
- Effective communicator — able to collaborate across engineering, quality, and operations teams
PREFERRED QUALIFICATIONS
- Experience supporting medical device manufacturing under ISO 13485
- Background in automation and controls validation — PLC, SCADA, or vision systems
- Experience with high-speed packaging or assembly line validation
- Exposure to validation remediation or regulatory commitment work
- Familiarity with MES or LIMS system validation in a GMP environment
WORK CONDITIONS
- Onsite support in a controlled GMP manufacturing environment
- Off-shift or weekend support may be required during validation execution windows
- PPE and gowning requirements apply depending on work area
- Candidates must be comfortable working in a production and controlled environment
