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.
