Process Engineer (Validation)
We are a growing international specialist healthcare company. Our mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. Due to continued growth, we have an exciting opportunity for a Process Validation Engineer to join our team in Farnham. The Process Validation Engineer will lead and execute the complete delivery of all validation projects and activities for manufacturing at the Farnham site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities. Principal Responsibilities To lead and execute Validation activities and Validation assignments supporting all manufacturing and packaging activities at the Farnham site involving the qualification of new and existing facilities, utilities, equipment (including sterilization) and computerized systems. Generation of related project documentation including but not limited to validation plans, protocols, reports Execution of validation testing for manufacturing and packaging equipment, utility systems equipment and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control. Education and Experience Degree in an appropriate scientific discipline. Minimum of 5 years' experience in the validation and qualification of manufacturing/packaging equipment qualification, systems qualification or process validation (computer systems validation / CSV would be advantageous) . Extensive experience in pharmaceutical validation and manufacturing with strong experience of front line involvement with Regulatory Inspections. Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material. Strong technical background, gained from a highly-regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices. Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.