Summary: Our client is a pharmaceutical company based in East Cork looking for a Senior CQV Engineer who will lead and coordinate the CQV project activities in line with the site procedures for commissioning, qualification & validation of utilities and process projects including some CSV.
The CQV Engineer will work across all project functions including EHS, Quality Operations, Finance, Operations, Process Engineering, Operational Engineering, Logistics, Lean & Digital to understand their functional requirements and develop and execute the optimum validation strategy.
Responsibilities: Support leadership of the capital projects function to manage CQV resources, manage timelines, drive safety compliance, quality compliance, delivery, and productivity.
Support project teams to successfully complete projects.
Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
Support the transition to a digitised C&Q platform (Kneat).
Manage and coordinate equipment qualification lifecycle activities, including but not limited to Validation Plan, URS, RTM & VSR as well as the full suite of qualification protocols: -Design Qualification (DQ), Factory Acceptance Testing (FAT), SAT, DQ Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
Support the Site Change Control Committee from a Validation point of view.
Support the creation and completion of Change Controls on the Quality Systems (Trackwise).
Manage and coordinate all CQV documentation to support CQV activities.
Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols.
Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
Qualifications & Experience: Relevant qualification (Degree) and experience of 10 + years in pharmaceutical industry commissioning and qualifying GXP systems.
Experience of managing teams or projects in a fast paced and complex environment.
Strong understanding of regulatory requirements to support a RBV (risk Based Validation) approach.
Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q platform.
Significant project lifecycle experience in delivering CQV for Process and Utilities Capex projects Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.