QA Validation Specialist

Katalyst CRO; Wilson (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a QA Validation Specialist in the United States to lead validation activities for equipment, utilities, and processes in a GMP environment.

The role focuses on developing, executing, and maintaining validation protocols (IQ/OQ/PQ) and ensuring data integrity, regulatory compliance, and effective collaboration with Quality Assurance, Regulatory Affairs, Engineering, and Manufacturing teams.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 5+ years validation experience in pharmaceutical environment.
• Experience with risk-based validation approaches and quality systems.
• Proficiency in Microsoft Office Suite and validation software tools.
• Excellent analytical, documentation, and communication skills.
• Collaborates with cross-functional teams and experience supporting validation projects.
• Knowledge regulatory guidelines (FDA, EMA, ICH Q7Q10), GAMP 5, and data integrity principles.
• Strong analytical, documentation, and communication skills.
• Demonstrated ability to assemble and lead small high-performing teams, proactively remove barriers to success, and foster alignment through consensus-building.
• Experience with software and enterprise systems (e.g., VeevaVault, SAP, Client-X)
• Experience in validated computer systems and knowledge of CSA / Data Integrity requirements.
• Hands-on experience applying LEAN methodologies (e.g., Value Stream Mapping, Kaizen, Root Cause Analysis) to drive process efficiency and continuous improvement.

Responsibilities

• Validation Lifecycle Management.
• Define and establish scope, objectives, and strategic approach for validation activities to ensure alignment with regulatory and quality standards.
• Support development and review of validation protocols (IQ/OQ/PQ) for equipment, utilities, and manufacturing processes.
• Ensure validation activities align with FDA, EMA, and ICH regulatory requirements and internal quality systems.
• Maintain the validated state of systems through periodic reviews, requalification, and change control assessments.
• Support for Engineering and Manufacturing.
• Collaborate with Engineering and Validation teams to ensure equipment design, installation, and operation meet GMP and validation requirements.
• Participate in risk assessments (e.g., FMEA, HACCP) for new and modified systems to proactively identify and mitigate potential quality and compliance risks.
• Support review of change controls, equipment specifications, and commissioning documentation.
• Promote consistent validation practices by providing coaching, hands-on support, and leading by example to reinforce quality standards and team alignment.
• Compliance and Documentation.
• Ensure validation documentation adheres to data integrity principles and regulatory expectations.
• Maintain accurate and complete validation records in accordance with internal SOPs and quality standards.
• Support internal and external audits by providing validation documentation and subject matter expertise.
• Deviation and CAPA Support.
• Investigate validation-related deviations and non-conformances.
• Support root cause analysis and implementation of corrective and preventive actions (CAPAs).
• Cross-functional Collaboration.
• Work closely with Quality Assurance, Quality Control, Regulatory Affairs, Engineering, and Manufacturing teams.
• Provide guidance on validation best practices and compliance requirements.
• GxP documents are current, approved, and accessible and follow document lifecycle requirements supporting minimal manual documentation through digital implementations
• Support Management in the development, implementation, sustainability and improvements of the trainings systems and standards for the new production site.
• Maintain new hire orientation training materials supporting sustainability and continuous improvement opportunities to the training system to ensure best in class.
• Generate reports and support training opportunities for continuous improvement.
• Support assign, monitor, and communicate training requirements
• Identify and drive opportunities for continuous improvement in validation processes, with a focus on enhancing quality, reducing costs, and optimizing service delivery to stakeholders.

Skills

Validation

Regulatory compliance

Risk-based validation

Documentation

Communication

Cross-functional

LEAN

Data integrity

GxP

Training systems

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Tools

VeevaVault

SAP

Client-X

Job description

Summary

The QA Validation Specialist is responsible to ensure that equipment, systems, and processes meet regulatory and internal quality standards through rigorous validation and qualification activities. This position focuses on the development, execution, and lifecycle management of validation protocols for equipment, utilities, and processes in a GMP-compliant pharmaceutical environment.

Roles & Responsibilities

• Validation Lifecycle Management
• Define and establish scope, objectives, and strategic approach for validation activities to ensure alignment with regulatory and quality standards.
• Support the development and review of validation protocols (IQ/OQ/PQ) for equipment, utilities, and manufacturing processes.
• Ensure validation activities align with FDA, EMA, and ICH regulatory requirements and internal quality systems.
• Maintain the validated state of systems through periodic reviews, requalification, and change control assessments.
• Support for Engineering and Manufacturing
• Collaborate with Engineering and Validation teams to ensure equipment design, installation, and operation meet GMP and validation requirements.
• Participate in risk assessments (e.g., FMEA, HACCP) for new and modified systems to proactively identify and mitigate potential quality and compliance risks
• support review of change controls, equipment specifications, and commissioning documentation.
• Promote consistent validation practices by providing coaching, hands-on support, and leading by example to reinforce quality standards and team alignment.
• Compliance and Documentation
• Ensure validation documentation adheres to data integrity principles and regulatory expectations.
• Maintain accurate and complete validation records in accordance with internal SOPs and quality standards.
• Support internal and external audits by providing validation documentation and subject matter expertise.
• Deviation and CAPA Support
• Investigate validation-related deviations and non-conformances.
• Support root cause analysis and implementation of corrective and preventive actions (CAPAs).
• Cross-functional Collaboration
• Work closely with Quality Assurance, Quality Control, Regulatory Affairs, Engineering, and Manufacturing teams.
• Provide guidance on validation best practices and compliance requirements.
• GxP documents are current, approved, and accessible and follow document lifecycle requirements supporting minimal manual documentation through digital implementations
• Support Management in the development, implementation, sustainability and improvements of the trainings systems and standards for the new production site.
• Maintain new hire orientation training materials supporting sustainability and continuous improvement opportunities to the training system to ensure best in class.
• Generate reports and support training opportunities for continuous improvement.
• Support assign, monitor, and communicate training requirements
• Identify and drive opportunities for continuous improvement in validation processes, with a focus on enhancing quality, reducing costs, and optimizing service delivery to stakeholders.

Required Skills

• Bachelors degree in Life Sciences, Engineering, or related field.
• 5+ years of validation experience in pharmaceutical environment.
• Experience with risk-based validation approaches and quality systems.
• Proficiency in Microsoft Office Suite and validation software tools.
• Excellent analytical, documentation, and communication skills.
• Collaborates with cross-functional teams and experience supporting validation projects.
• Knowledge regulatory guidelines (FDA, EMA, ICH Q7Q10), GAMP 5, and data integrity principles.
• Strong analytical, documentation, and communication skills.
• Demonstrated ability to assemble and lead small high-performing teams, proactively remove barriers to success, and foster alignment through consensus-building.
• Experience with software and enterprise systems (e.g., VeevaVault, SAP, Client-X)
• Experience in validated computer systems and knowledge of CSA / Data Integrity requirements.
• Hands-on experience applying LEAN methodologies (e.g., Value Stream Mapping, Kaizen, Root Cause Analysis) to drive process efficiency and continuous improvement.