GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. VALIDATION ENGINEER Responsibilities: Active participation in the Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. QA support for validation investigations and implementation of corrective actions. Vendor supervision for execution of validation activities. Execution of Autoclave, Parts washer, Lyo, CIP and SIP, VHP and Temperature Mapping to meet initial validation and revalidation requirements. Creation/Review/Approval of various validation and qualification documents Management of validation, exception event, and change control Documenting all activities in line with cGMP requirements. Performing cross training within the team and training of new team Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Qualifications: Relevant degree and 5 years' experience Autoclave validation execution experience (prefferrd) Aseptic processing validation including media fills and VHP validation execution (prefferred) HVAC validation (prefferred) #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
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