Sr. CQV Engineer

Job Description

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.

Key Accountabilities:

Ensure that personal safety and the safety of team members is prioritized at all times. Ensures that all permits, LOTO, SPA, and required EH&S training are in place or completed prior to performing any CQV activities.
 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.
 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.
 Coordinate with the Engineering Leads and QAV Leads to establish Test Plans that capture strategy for CQV testing, test scripts and acceptance criteria
 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.
 Actively manage the execution of all CQV testing with a very low deviation level.
 For CQV testing that is planned during the FAT phase and leveraged as defined in the Project Validation Master Plan (PVMP)
 Partner with the Engineering Lead to plan for the testing and ensure that the vendor and vendor documents are ready for CQV level testing.
 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.
 Produce Monthly Reports for the CQV Phase, in line with overall project reporting requirements.
 Attend & contribute to CQV and project meetings as required to communicate status, share learning, and participate in planning discussions.
 For systems requiring cycle development (CD) and performance qualification (PQ), generate document, execute studies, gather data and generate final CD and PQ reports.
 Maintain the site Equipment Validation Master Plan
 May be required to perform other duties as assigned.

Educational and Experience Requirements:

A minimum of a Level 8 Bachelor’s Degree in Engineering, Science or an equivalent technical discipline.
 A minimum of 8 years of relevant experience in the biotechnology and/or pharmaceutical industry or commensurate experience.
 At least 2 years experience in the planning, document generation, support or execution of CQV activities in a biologic drug substance manufacturing plant.
 Experience with CQV execution in a greenfield plant is highly desirable.
 Knowledge of engineering principles as applied in a biotechnology and/or pharmaceutical manufacturing environment is required.
 Thorough understanding of good engineering practices (GEP) and good manufacturing practices (GMP) is required.
 Experience developing and executing IQ (Installation Qualification), OQ (Operational Qualification and PQ (Performance Qualification) Protocols.
 Knowledge of cycle development (CD) and performance qualification (PQ) practices is highly desirable.
 Excellent communication skills (written and oral).
 Ability to multi-task and handle tasks with competing priorities effectively.
 Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures).
 Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
 Ability to manage multiple priorities and know when to escalate issues for resolution.
 Proficiency in Microsoft Office and job-related computer applications required.
 Experience with paperless validation systems is an advantage.

Other Job Requirements:
 This role is a site based role.
 

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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 Preferred Skills:

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