CQV Engineer

1 week ago

Sligo Co Sligo, Ireland Gertek Project Management Full time

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 with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: CQV Engineer Job Responsibilities Execute Commissioning and validation of manufacturing equipment, downstream equipment, and processes in addition to supervising and witnessing CQ carried out by vendors Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning and Qualification protocols CQV documentation - drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines. Develop protocols for validation projects using a risk-based approach that meets regulatory requirements and industry practices Accountable for scheduling, tracking, reporting, and achieving validation deadlines. Lead Risk assessments for process and equipment as required Review and approve Layout development and review for material and personnel flow compliance Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Promote cGMP and regulatory compliance into assigned projects Education & Key Requirements Degree educated in Engineering or related discipline 3years plus experience commissioning, qualification, and validation in GMP product manufacturing. Proven track record in generation of validation/verification documentation. Proven experience with international pharmaceutical projects Excellent technical abilities, Problem solving skills, strong technical writing, and communication skills. Excellent knowledge of relevant GMPs, regulations and current industry trends. We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated CQV Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below.

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