MSAT Validation Engineer

• Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval
• Review and approve documents prepared by other MSAT colleagues
• Field execution of MSAT protocols
• Liaise with Manufacturing to provide support where required with routine operations/project-based work
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports
• Representing the MSAT site team on platform technical teams
• Initiate and implement change control activities in accordance with site procedures
• Track and resolve exceptions/events/deviations during MSAT activities
• Prioritize MSAT activities in line with Manufacturing/project schedules
• Co-ordinate MSAT activities with contractors and vendors as required
• Attend identified training required to fulfil the role of a MSAT Engineer
• Participate in multi-functional teams (project, investigations) as required

• A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required
• At least 2 yrs experience in the Large Molecule manufacturing industry or equivalent
• Experience in Cleaning Validation studies and Cleaning Strategy (Minimum 2 years)
• Also beneficial would be experience in Thermal Validation, Process Validation, Supporting Process Improvement Projects, Supporting New Product Introduction

Life Science Recruitment