Validation Engineer

We are seeking a highly motivated and experienced Validation Engineer. This pivotal role will drive critical qualification programmes and contribute directly to a world-class, high-volume manufacturing operation.

This is an excellent opportunity to make a high impact and join a growing team within the biopharma space.

Key Responsibilities:

• Lead and execute process, system, and equipment validations per established Validation Master Plans (VMP) and project schedules.
• Author, execute, and finalize comprehensive Validation Protocols and Reports (e.g., IQ, OQ, PQ, CSV), ensuring rigorous compliance with cGMP and Regulatory requirements (FDA, EMA).
• Proactively identify continuous improvement opportunities and lead relevant Validation/Quality system enhancement projects.
• Monitor and manage validation project progress, ensuring adherence to demanding timelines and providing regular updates to stakeholders.
• Deliver necessary training to ensure relevant departments comply with validation programme requirements.
• Lead the investigation of Quality/Validation deviations using Root Cause Analysis (RCA) and implement effective Corrective and Preventative Actions (CAPA).
• Coordinate formal Risk Mitigation activities, including Failure Modes and Effects Analysis (FMEA).
• Strictly adhere to all EHS guidelines and Quality procedures.

Skills, Attributes & Experience:

• Degree in Engineering, Life Sciences, or a closely related technical discipline.
• Minimum of 4+ years of direct experience in a dedicated Validation or Quality Engineering role within Pharma, Biotech, or Medical Device sectors.
• Proven hands-on experience in generating and executing comprehensive validation lifecycle documents (IQ, OQ, PQ, and potentially CSV).
• Demonstrated ability to manage multiple complex projects concurrently and meet tight deadlines; strong time management is essential.
• Experience with risk management tools (FMEA) and structured problem-solving (RCA/CAPA) is highly desirable.