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.
