Onsite Validation Engineer — cGMP/GDP Expert

R Dpartners; Munster; On-site; EUR 55,000 - 69,000; Full time

Job summary

R&D Partners is seeking a Validation Engineer to join a leading pharmaceutical company in ROI. This is a fully onsite contract role offering competitive hourly compensation.

The role focuses on ensuring cGMP and GDP compliance across equipment, systems, facilities, and processes, while supporting validation activities and related documentation. Responsibilities include executing and reviewing IQ/OQ/PQ, risk assessments, SOP updates, and cross‑functional coordination with Quality Control and

Qualifications

• Experience with equipment qualification, process validation, and cleaning validation.
• Ability to prepare and review validation protocols and reports.
• Strong knowledge of cGMP and GDP requirements.
• Experience coordinating cross-functional validation activities.
• Familiarity with risk assessment methodologies.
• Excellent organizational and communication skills.

Responsibilities

• Execute and review qualification, re-qualification, and validation for equipment, systems, facilities, and plant utilities.
• Prepare and review IQ/OQ/PQ protocols and reports for 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

Validation protocol writing

Cross-functional coordination

Risk assessment

Communication skills

Job description

R&D Partners is seeking a Validation Engineer to join a leading pharmaceutical company in ROI. This is a fully onsite contract role offering competitive hourly compensation.

The role focuses on ensuring cGMP and GDP compliance across equipment, systems, facilities, and processes, while supporting validation activities and related documentation. Responsibilities include executing and reviewing IQ/OQ/PQ, risk assessments, SOP updates, and cross‑functional coordination with Quality Control and