Validation Specialist

Role:Validation Specialist
Location: Marion, NC (Onsite) Required Skills & Experience

• Validation (IQ, OQ, PQ, Requalification)
• FDA cGMP Regulations & Compliance
• Medical Device Manufacturing Environment
• ISO 13485 Experience
• KNEAT Gx Validation Lifecycle Management
• Commissioning, Qualification & Validation (CQV)
• Validation Protocol Authoring & Execution
• Change Control, Deviations & CAPA Management
• Strong understanding of 21 CFR Part 11 and Data Integrity requirements
• Experience supporting regulated pharmaceutical and/or medical device operations
• Baxter experience is highly preferred

Position Overview

We are seeking an experienced Validation Specialist to support pharmaceutical and medical device manufacturing operations. This role will be responsible for executing and maintaining validation activities using KNEAT Gx as the electronic validation lifecycle management system. The successful candidate will work cross-functionally with Engineering, Quality, Automation, IT, and Operations teams to ensure validated systems remain compliant, inspection-ready, and capable of supporting safe and efficient production.

Key Responsibilities Validation Execution

• Execute and support IQ, OQ, PQ, requalification, and validation maintenance activities.
• Validate manufacturing and packaging equipment, utilities, and computerized systems.
• Support validation activities for:
  • Manufacturing and assembly equipment
  • Packaging systems
  • Utilities (compressed air, environmental controls, clean utilities)
  • MES, LIMS, automation systems, vision systems, and data acquisition platforms
• Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices.

KNEAT Gx Administration & Documentation

• Author, execute, review, and route validation documentation within KNEAT Gx.
• Develop and maintain:
  • User Requirement Specifications (URS)
  • Risk Assessments
  • Validation Protocols and Test Scripts
  • Deviations and Validation Reports
• Ensure complete traceability throughout the validation lifecycle.
• Maintain compliance with electronic records and signatures requirements (21 CFR Part 11).

Compliance & Quality Support

• Investigate and document validation deviations.
• Support change control assessments impacting validated systems.
• Participate in root cause investigations and CAPA implementation.
• Ensure validation deliverables comply with:
  • FDA cGMP Regulations (21 CFR Parts 210, 211, and Part 11)
  • ISO 13485 requirements
  • Internal Quality Management Systems (QMS)
• Support regulatory inspections, audits, and validation readiness activities.

Cross-Functional Collaboration

• Partner with Engineering, Manufacturing, Quality, Automation, IT, and external vendors.
• Provide on-floor support during commissioning, troubleshooting, and validation execution.
• Support new equipment installations, line upgrades, remediation projects, and capacity expansion initiatives.

Preferred Qualifications

• Experience supporting medical device manufacturing under ISO 13485.
• Hands-on experience with PLC/SCADA systems, MES platforms, or vision systems.
• Experience validating high-speed packaging or assembly lines.
• Exposure to validation remediation programs and regulatory commitment projects.
• Prior experience in Baxter or similar highly regulated manufacturing environments.

Required Competencies

• Strong attention to detail and compliance mindset.
• Excellent problem-solving and root cause analysis skills.
• Ability to work independently and manage project deliverables.
• Effective communication and collaboration across cross-functional teams.
• Comfortable working in GMP-controlled manufacturing environments.

Work Environment

• Onsite role in Marion, NC.
• GMP-regulated pharmaceutical and medical device manufacturing environment.
• Occasional off-shift or weekend support may be required during validation execution activities.
• PPE and gowning requirements apply based on work area.