Onsite Contract Validation Engineer — cGMP/GDP

R&D Partners; Munster; On-site; EUR 55,000 - 69,000; Full time

Job summary

R&D Partners in ROI, Ireland, is seeking a Validation Engineer to ensure pharmaceutical processes, equipment and systems meet cGMP and GDP standards. This onsite contract role offers competitive hourly compensation and will involve validation across equipment, systems, and plant utilities.

The ideal candidate will prepare and review validation protocols, execute qualification activities, coordinate cross-functional teams, and maintain compliant validation records.

Qualifications

• Strong knowledge of cGMP and GDP requirements.
• Experience in equipment qualification, process validation, and cleaning validation.
• Proficiency in preparing and reviewing validation protocols and reports.
• Ability to coordinate cross-functional teams for validation activities.
• Familiarity with risk assessment methodologies.
• Excellent organizational and communication skills.

Responsibilities

• Execute and review Qualification, Re-Qualification, and Validation activities for equipment, systems, facilities, and plant utilities.
• Prepare and review protocols and reports for Installation, Operational, and Performance Qualification of equipment, facilities, and utilities.
• Develop, execute, and review validation activities for manufacturing equipment such as vessels, blenders, and filling lines.
• Coordinate Process Validation and Cleaning Validation activities, including protocol preparation and report compilation.
• Collaborate with Quality Control and Microbiology departments for sample preparation and testing during validation studies.
• Conduct risk assessments related to equipment, processes, utilities, facilities, and systems.
• Maintain and update validation records in compliance with cGMP and GDP standards.
• Prepare and revise SOPs related to validation and IPQA activities.
• Work with design consultants and user departments to ensure proper design and approval of manufacturing equipment.
• Support the Validation Master Plan schedule and data collection activities.
• Perform additional duties as required by the Head of Department or designated deputy.

Skills

cGMP knowledge

GDP knowledge

Equipment qualification

Process validation

Cleaning validation

Protocol development/review

Cross-functional coordination

Risk assessment

Validation Master Plan

Documentation

Job description

R&D Partners in ROI, Ireland, is seeking a Validation Engineer to ensure pharmaceutical processes, equipment and systems meet cGMP and GDP standards. This onsite contract role offers competitive hourly compensation and will involve validation across equipment, systems, and plant utilities.

The ideal candidate will prepare and review validation protocols, execute qualification activities, coordinate cross-functional teams, and maintain compliant validation records.