GMP Validation Lead - Equipment & Processes

Creative Solutions Services, LLC; Wilson (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC seeks a QA Validation Specialist to ensure equipment, utilities and processes meet GMP and regulatory quality standards through lifecycle validation activities.

You will develop, execute and maintain validation protocols (IQ/OQ/PQ), support audits, risk assessments, change controls, and cross‑functional collaboration with QA, Regulatory, Engineering and Manufacturing. Emphasis on data integrity and LEAN-driven process improvements.

Qualifications

• Bachelor's 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.

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.

Education

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

Tools

VeevaVault

SAP

Client-X

Job description

Creative Solutions Services, LLC seeks a QA Validation Specialist to ensure equipment, utilities and processes meet GMP and regulatory quality standards through lifecycle validation activities.

You will develop, execute and maintain validation protocols (IQ/OQ/PQ), support audits, risk assessments, change controls, and cross‑functional collaboration with QA, Regulatory, Engineering and Manufacturing. Emphasis on data integrity and LEAN-driven process improvements.