Validation Engineer

We are looking for an experienced Validation Engineer ready to drive critical qualification programmes and contribute directly to a world-class manufacturing operation. This is an exciting chance to join a growing, high-impact team.

This is a 12 month contract position.

Key Responsibilities:

• Take ownership of process, systems, and equipment validations in accordance with Validation Master Plans and project schedules.
• Participate in cross-functional teams to establish robust validation strategies and objectives, supporting process and equipment changes.
• Prepare, execute, and complete Validation Protocols and Reports, ensuring strict compliance with all relevant Quality standards and Regulatory requirements.
• Maintain expertise in applicable regulations and guidance documents. Review existing practices, identify opportunities for continuous improvement, and lead improvement projects.
• Monitor the progress of validation projects, ensuring adherence to schedule, and provide regular stakeholder updates.
• Ensure all relevant departments understand and comply with validation programme requirements, providing necessary training.
• Lead thorough investigation of Quality and Validation issues using Root Cause Analysis (RCA) and implement robust Corrective and Preventative Actions (CAPA).
• Lead and coordinate Risk Mitigation initiatives such as FMEA (Failure Modes and Effects Analysis) and Risk Assessments.
• Adhere to all EHS guidelines and Quality procedures.

Skills, Attributes & Experience

• Degree in Engineering or related discipline.
• Minimum of 4 years + experience working in a Quality Engineer or Validation role within Pharmaceuticals or Medical Device.
• Experience generating validation documents - IQ, OQ & PQ.
• The successful candidate must demonstrate strong time management and organisational skills.
• Excellent communication is essential.