Validation Specialist; KNEAT Gx

Validation Specialist (KNEAT Gx)

Client is seeking an experienced Validation Specialist with strong KNEAT Gx experience to support validation activities within a regulated pharmaceutical and medical device manufacturing environment. The ideal candidate will be responsible for executing validation protocols, maintaining compliance with FDA and ISO standards, and supporting validation lifecycle activities for equipment, utilities, processes, and computerized systems.

• Execute and support IQ, OQ, PQ, requalification, and validation maintenance activities.
• Perform validation activities for manufacturing equipment, packaging equipment, utilities, and computerized systems.
• Author, execute, review, and route validation documents using KNEAT Gx.
• Maintain traceability between User Requirements Specifications (URS), risk assessments, test scripts, deviations, and validation reports.
• Support Computer System Validation (CSV) activities for automation systems, MES, LIMS, SCADA, PLCs, and data acquisition systems.
• Apply risk-based validation methodologies aligned with GAMP 5 guidelines.
• Investigate validation deviations and support CAPA and change control activities.
• Participate in root cause analysis and implement corrective actions.
• Ensure compliance with FDA cGMP regulations, 21 CFR Part 11, and ISO 13485 requirements.
• Maintain validation documentation in an audit-ready state.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and IT teams.
• Provide floor support during commissioning, qualification, troubleshooting, and validation execution.
• Support new equipment installations, line expansions, remediation projects, and manufacturing improvements.
• Assist during internal audits, customer audits, and regulatory inspections.

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related discipline.
• 3+ years of validation experience within pharmaceutical, biotechnology, or medical device industries.
• Hands-on experience with KNEAT Gx validation lifecycle management platform.
• Experience executing IQ/OQ/PQ protocols and validation documentation.
• Strong knowledge of FDA cGMP regulations and 21 CFR Part 11 requirements.
• Understanding of GAMP 5 risk-based validation methodologies.
• Experience with deviation management, CAPA, and change control processes.
• Excellent documentation, communication, and problem-solving skills.
• Ability to work independently in a GMP-regulated manufacturing environment.

• Experience supporting medical device manufacturing environments regulated by ISO 13485.
• Experience with PLC, SCADA, MES, LIMS, or vision systems validation.
• Experience supporting high-speed packaging or assembly operations.
• Previous involvement in validation remediation projects or regulatory commitment programs.
• Experience supporting commissioning and qualification activities.

• Strong compliance and quality mindset.
• Attention to detail and documentation accuracy.
• Effective cross-functional collaboration.
• Root cause analysis and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

• Onsite role located in Marion, NC.
• GMP-regulated pharmaceutical and medical device manufacturing environment.
• PPE and gowning requirements may apply.
• Occasional off-shift, evening, or weekend support may be required based on project schedules.