Senior CQV Engineer

Tandem Project Management View all jobs

  • Cork
  • Contract
  • Full-time
  • 2 months ago
  • Apply easily
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.

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