GMP Validation Specialist – Lifecycle & Compliance

Katalyst CRO; Wilson (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Validation

Regulatory compliance

Risk-based validation

Documentation

Communication

Cross-functional

LEAN

Data integrity

GxP

Training systems

Educación

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

Herramientas

VeevaVault

SAP

Client-X

Descripción del empleo

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.