Senior Validation Specialist

Next Generation; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Next Generation is seeking a senior Validation professional to lead qualification and validation of equipment, facilities and utilities within a GMP pharmaceutical environment. You will shape validation strategies, Master Plans, procedures and guidance while ensuring compliance with GMP and regulatory standards.

In this role you will mentor the validation team, support deviations and change controls, and drive continuous improvement across validation lifecycle activities, including temperature

Qualifications

• Bachelor’s degree in Science, Engineering or a related discipline.
• 8+ years’ pharmaceutical validation experience.
• Strong equipment, facility and utility qualification experience within a GMP environment.
• Good knowledge of validation lifecycle, risk assessment and root-cause analysis.
• Experience with deviations, change controls and electronic quality/documentation systems.
• Experience with temperature mapping and data-logging systems such as Ellab, Kaye or equivalent.
• Experience within aseptic and/or non-aseptic pharmaceutical manufacturing environments.
• Strong communication, technical problem-solving and stakeholder management skills.

Responsibilities

• Lead qualification and validation activities for equipment, facilities and utilities.
• Develop and maintain validation strategies, Validation Master Plans (VMPs), procedures and guidance.
• Ensure validation activities comply with current GMP and regulatory requirements.
• Support equipment and system lifecycle activities and ongoing validation compliance.
• Review and support deviations, investigations, change controls and validation corrective actions.
• Perform risk assessments and apply scientific rationale to validation approaches.
• Support temperature mapping and data-logging activities.
• Maintain high standards of product quality, patient safety and data integrity.
• Support regulatory inspections and audits from a validation perspective.
• Collaborate with Quality, Engineering, Manufacturing and other technical teams.
• Drive improvements in validation processes and best practices.
• Provide technical guidance and mentoring to validation team members.

Skills

Communication

Problem-solving

Stakeholder management

Education

Bachelor’s degree in Science/Engineering

Tools

ValGenesis

Veeva

MAXIMO

TrackWise

Job description

A senior Validation role leading equipment, facility and utility qualification within a GMP pharmaceutical environment, with responsibility for validation strategy, compliance and continuous improvement.

Key Responsibilities

• Lead qualification and validation activities for equipment, facilities and utilities.
• Develop and maintain validation strategies, Validation Master Plans (VMPs), procedures and guidance.
• Ensure validation activities comply with current GMP and regulatory requirements.
• Support equipment and system lifecycle activities and ongoing validation compliance.
• Review and support deviations, investigations, change controls and validation corrective actions.
• Perform risk assessments and apply scientific rationale to validation approaches.
• Support temperature mapping and data-logging activities.
• Maintain high standards of product quality, patient safety and data integrity.
• Support regulatory inspections and audits from a validation perspective.
• Collaborate with Quality, Engineering, Manufacturing and other technical teams.
• Drive improvements in validation processes and best practices.
• Provide technical guidance and mentoring to validation team members.

Experience Required

• Bachelor’s degree in Science, Engineering or a related discipline.
• 8+ years’ pharmaceutical validation experience.
• Strong equipment, facility and utility qualification experience within a GMP environment.
• Good knowledge of validation lifecycle, risk assessment and root-cause analysis.
• Experience with deviations, change controls and electronic quality/documentation systems.
• Experience with ValGenesis, Veeva, Maximo and/or TrackWise advantageous.
• Experience with temperature mapping and data-logging systems such as Ellab, Kaye or equivalent.
• Experience within aseptic and/or non-aseptic pharmaceutical manufacturing environments.
• Strong communication, technical problem-solving and stakeholder management skills.