Sr. CQV EngineerExperience Level: Senior Level | Posted Date: 15/04/2025
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
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Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
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Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/29/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.