Validation Consultant

EPM Scientific are currently supporting a key client to hire a Sr. Validation Consultant to join the team on a 9 month project, supporting primarily capacity expansion activities.

This is a full time, ASAP start role. Initially, the contract is for 9 months, however the role could extend long term if all is aligned.

The client is a Global MedTech manufacturer primarily in the Cardiovascular space.

Key support areas:

• Provide leadership, technical guidance, and subject matter expertise in validation and quality assurance activities across manufacturing, facilities, equipment, computerised systems, utilities, cleaning, and process validation programmes.

• Support validation lifecycle activities by coaching and advising validation engineers, quality personnel, and cross-functional teams in the development, execution, and closure of validation projects.

• Review, approve, and provide expert input into validation deliverables, including Validation Master Plans, protocols, reports, risk assessments, deviation investigations, change controls, and qualification documentation to ensure compliance with internal standards and regulatory expectations.

• Ensure validation activities are conducted in accordance with applicable regulations and standards, including GMP, FDA, EMA, ISO 13485, EU MDR, and other relevant quality and regulatory requirements.

• Act as the quality representative for validation-related activities, ensuring validation strategies are scientifically justified, risk-based, and aligned with industry best practices.

• Mentor and develop validation and quality team members by providing technical coaching, training, and knowledge sharing to enhance organisational capability and compliance awareness.

• Lead and support investigations related to validation deviations, non-conformances, CAPAs, and change control activities, ensuring robust root cause analysis and effective corrective actions.

• Collaborate with Engineering, Manufacturing, Operational Excellence, Regulatory Affairs, Supply Chain, and external stakeholders to ensure successful delivery of validation and qualification projects.

• Drive continuous improvement initiatives aimed at enhancing validation processes, reducing compliance risks, and improving operational efficiency.

• Support internal and external audits, regulatory inspections, and customer audits by providing validation expertise and ensuring readiness of validation documentation and supporting evidence.

• Monitor emerging regulatory expectations and industry trends, ensuring validation practices remain current, effective, and compliant.

• Serve as the technical authority for validation and qualification matters, providing guidance on complex quality and compliance issues and supporting strategic decision-making.