Process & Cleaning Validation Specialist

Currently recruiting for 2 Validation Engineers to join a high-performing Validation & Quality team. This role will be primarily responsible for authoring process and cleaning validation protocols, overseeing study execution, analysing the findings, and creating written reports summarising the findings. This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations. Responsibilities: To follow the technology transfer phases from the initial project kick-off to the commercial readiness, acting as a point of reference for Quality and Validation technical aspects. To work closely with technical and quality teams to develop a robust validation strategy. To author Process and Cleaning Validation protocols and reports for registration and validation batches, in accordance with GMP and corporate standards To provide Qualitative and Technical recommendations to permit site operation within regulatory requirements. To statistically process data through computer applications (Excel/Minitab) To oversee manufacturing activities related to registration and validation batches To ensure that new product introduction and all process changes are adequately evaluated and handled through change control management To support in preparation and participation to Clients and Regulatory audits with regards to validation activities. EH&S: Understand and ensure implementation of emergency procedures and safe systems of work. Ensure compliance with environment, health and safety rules, signage and instructions at all times. Ensure timely reporting and investigation of all accidents, near misses and breaches of rules. Minimum Requirements/Qualifications: Science based degree e.g. BSc or MSc Previous professional experience in process and cleaning validation in the pharmaceutical industries, preferably sterile manufacturing. Proficient knowledge of process validation, cleaning validation and continuous process improvement. Knowledge of mainstream statistical software analysis programs such as MiniTab. Solid understanding of EU/US GMP regulations and guidelines for UK as per the Orange Guide. Technical writing skills - Deviations, reports, investigations, SOPs. Excellent interpersonal skills, communication, and organizational skills • Ability to multi-task, meeting tight deadlines