Sr. CQV Engineer

<p>Job Description</p><p></p><p>The Senior CQV Engineer will oversee the establishment and execution of the generation of documents and and field execution for CQV activities, in some cases leading a team of CQV Engineers or third party providers, for the CQV delivery of various facility, systems, and equipment at Our Company Dunboyne Biologics.</p><p></p><p>Key Accountabilities:</p><p></p><p>Ensure that personal safety and the safety of team members is prioritized at all times. Ensures that all permits, LOTO, SPA, and required EH&amp;S training are in place or completed prior to performing any CQV activities.<br/> Lead a team of CQV Engineers and/or third party service providers to execute all phases of CQV activities. Ensure that Project Execution Plans covering Deviations and Project Change Controls are followed during all CQV phases.<br/> Work with the Engineering and QAV/QA teams to ensure that the appropriate Quality standards are applied for the CQV phase of the project, consistent with best practice and internal Quality Standards and expectations.<br/> Coordinate with the Engineering Leads and QAV Leads to establish Test Plans that capture strategy for CQV testing, test scripts and acceptance criteria<br/> Work with the Project Automation team, determine and coordinate automation testing that will be required as part of the equipment/system(s) assigned in the CQV Lead scope.<br/> Actively manage the execution of all CQV testing with a very low deviation level.<br/> For CQV testing that is planned during the FAT phase and leveraged as defined in the Project Validation Master Plan (PVMP)<br/> Partner with the Engineering Lead to plan for the testing and ensure that the vendor and vendor documents are ready for CQV level testing.<br/> Work the Project CQV Lead and Project Schedulers, ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained.<br/> Produce Monthly Reports for the CQV Phase, in line with overall project reporting requirements.<br/> Attend &amp; contribute to CQV and project meetings as required to communicate status, share learning, and participate in planning discussions.<br/> For systems requiring cycle development (CD) and performance qualification (PQ), generate document, execute studies, gather data and generate final CD and PQ reports.<br/> Maintain the site Equipment Validation Master Plan<br/> May be required to perform other duties as assigned.</p><p></p><p>Educational and Experience Requirements:</p><p></p><p>A minimum of a Level 8 Bachelor’s Degree in Engineering, Science or an equivalent technical discipline.<br/> A minimum of 8 years of relevant experience in the biotechnology and/or pharmaceutical industry or commensurate experience.<br/> At least 2 years experience in the planning, document generation, support or execution of CQV activities in a biologic drug substance manufacturing plant.<br/> Experience with CQV execution in a greenfield plant is highly desirable.<br/> Knowledge of engineering principles as applied in a biotechnology and/or pharmaceutical manufacturing environment is required.<br/> Thorough understanding of good engineering practices (GEP) and good manufacturing practices (GMP) is required.<br/> Experience developing and executing IQ (Installation Qualification), OQ (Operational Qualification and PQ (Performance Qualification) Protocols.<br/> Knowledge of cycle development (CD) and performance qualification (PQ) practices is highly desirable.<br/> Excellent communication skills (written and oral).<br/> Ability to multi-task and handle tasks with competing priorities effectively.<br/> Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures).<br/> Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.<br/> Ability to manage multiple priorities and know when to escalate issues for resolution.<br/> Proficiency in Microsoft Office and job-related computer applications required.<br/> Experience with paperless validation systems is an advantage.</p><p></p><p>Other Job Requirements:<br/> This role is a site based role.<br/> </p><p></p><p></p><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p><b>Search Firm Representatives Please Read Carefully </b><br/>Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement i