Asset Recruitment Ltd

CQV Lead (BB-B816E)

Found in: Neuvoo IE

CQV Lead candidate must be a highly motivated leader with solid interpersonal skills that allow them to collaborate well with various individuals, groups and departments, in addition to a technical foundation.The successful candidate must have upfront development of the C&Q strategy, Initially, this role will cover the front-end aspects as well as hands-on capability later in project.This project is expected to run until the end of 2023Responsibilities: 1. Lead and coordinate commissioning and qualification activities on a biologics expansion project incorporating utilities, Labs and process equipment. Ensure compliance with HPRA, MHRA, FDA and cGMP requirements 2. Plan and track activities and liaise with the various stakeholders on the commissioning team and the overall project. Provide technical process support to the commissioning team throughout the project life cycle. Participation in HAZOP and design reviews. Oversee the generation, execution and approval of Commissioning & Qualification documentation. 3. Management of vendor engineers and contractors during C&Q activities; 4. Ensure that handover from construction to commissioning is properly defined, documented and in line with project requirements ensuring handover packages are reviewed and complete. 5. Ensure that C&Q activities are scheduled, budgeted and resourced in line with the project delivery requirements. Ensure sequencing of handover of systems is properly aligned with the project requirements. Develop, agree and provide all required trainingBASIC QUALIFICATIONS: 1. Third level degree in a relevant discipline; Proven level of experience in delivering Commissioning, Qualification & Validation (CQV) activities within the biotechnology sector including developing all required Project Validation Plans, Master Plans, System Lists, Commissioning Procedures etc 2. At least 10 years of experience in a cGMP manufacturing environment with minimum of 5 years in a lead role. 3. A proven track record of leading commissioning and qualification activities of complex projects and developing cross-functional initiatives. 4. In-depth understanding of large scale biotechnology unit operations, principles of biochemical engineering, and process data analysis; 5. Strives for results and sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets; 6. Strong knowledge and experience in GMP environment and working within Quality System; 7. Strong knowledge and experience in project management, ASME BPE, and ISPE guidelines; 8. Good knowledge and experience in EHS; 9. Self-motivated with minimum management and Good communications skill; 10. Fluent in written and verbal English communication.PREFERRED QUALIFICATIONS: 1. Proven leadership capabilities in a prior role; 2. Able to engage and align other stakeholders outside the project team; 3. Ability to understand and communicate risks and develop and execute contingency plans; 4. Extensive experience in the operation of large scale biotechnology processes; 5. Hands on experience with large scale biotechnology unit operations; 6. Bio-process manufacturing experience is highly desirable; 7. Proven ability to lead cross-functional and technical teams and align, motivate and empower team members

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