CQV Engineer

1 week ago

Cork, Ireland Tandem Project Management Limited Full time

Summary: A CQV Engineer is required to join the Solution Preparation area at our client site in East Cork, a leading pharmaceutical facility. The successful candidate will lead and coordinate CQV activities in alignment with the sites project strategy. This role involves close collaboration with a range of functions, including Process Engineering, Operations, Engineering, Quality, EHS, Logistics, and Lean & Digital, to understand requirements and develop and execute an effective, compliant validation strategy. Responsibilities: Guide CQV activities for solution prep, ensuring timely execution and compliance with industry regulations. Develop, review, approve and execute the commissioning, installation and qualification protocols, ensuring all issues identified during execution are managed correctly, efficiently and in accordance to site/project procedures. Generate, review and approve Validation Plan, SRA, DQ, and URS. Manage and coordinate Solution Prep equipment commissioning and qualification activities. Review and approve vendor/ field turnover packs for all equipment associated to the Solution Prep area. Act as the CQV point of contact between clients, internal teams, and external vendors to drive project success. Provide technical oversight and guidance to resolve issues as they arise in a collaborative manner. Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards. Qualifications & Experience: Relevant qualification (degree) and/or a minimum of 10 years experience in the biotech or pharmaceutical industry, with a strong background in qualifying GxP systems. Prior experience operating as a senior CQV Engineer with a solid technical background. Previous experience collaborating with vendors such as BCD, Hetch, Rockwell, and/or exposure to solution preparation or formulation processes. Strong understanding of Risk-Based Validation (RBV) principles and hands-on experience deploying and executing RBV in line with ISPE guidelines within a large capital project environment. Experience working with digital C&Q platforms such as Kneat Solutions. Clear knowledge of EU and other global regulatory requirements, ensuring CQV activities are delivered in full compliance with all applicable regulations and guidelines.

  • CQV Engineer

    3 weeks ago

    Cork, Ireland Quanta Consultancy Services Ltd Full time

    Overview CQV Engineer - Ireland, Cork - 6 Month Contract Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a CQV Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and...

  • (15h Left) Project Engineer

    3 weeks ago

    Cork, Ireland Tandem Project Management Ltd. Full time

    Our client, a leading pharmaceutical manufacturing company based in Co. Kerry, is seeking a CQV Engineer (Lyophiliser) to join their team. The successful candidate will be responsible for commissioning, qualification, and validation (CQV) activities associated with lyophilisation systems and related utilities in a GMP manufacturing...

  • 2025 Client-based Engineering Opportunities

    3 weeks ago

    Cork, Ireland PM Group Full time

    Overview Are you looking for a new challenge? To diversify your experience? Partner with a Global business working to make the world better? Change to a new Industry? Or try a new role or a new location? The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their...

  • Urgent Search: Robotics Engineer

    4 weeks ago

    Cork, Ireland Tandem Project Management Limited Full time

    Summary: Our client, a pharmaceutical company located in East Cork, is looking for a Robotics Engineer to join their team. The successful candidate will be responsible for the design and implementation of advanced automation solutions, including Autonomous Mobile Robots (AMRs), robotic loading and unloading systems, and vial tracking technologies. The...

  • Business Development

    5 days ago

    Cork, Ireland Advanced Manufacturing Tech Solutions Full time

    Advanced Manufacturing Tech Solutions (AMTSOL) - www.amtsol.com As a global technical services and solutions provider for the life sciences manufacturing industry, and due to our continued growth, we are looking for top talent to join our dynamic team and drive the growth of the business in Europe with our top-tier pharma and biotech client base in Ireland,...

  • Utilities Lead

    2 weeks ago

    Cork, Ireland Quanta part of QCS Staffing Full time

    Utilities Lead - Pharmaceuticals - Cork - 12-Month Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the stunning surroundings of Cork. Due to a large capital investment and multiple projects on site, the client is looking for a Utilities Lead with to join their team. If you are local to Cork and interested in...

  • Project Controls Manager

    4 weeks ago

    Cork, Ireland PM Group Full time

    Overview At PM Group Cork, we have a dedicated Project Controls Department and due to new projects we are looking for a Project Controls Manager. We currently have several significant pharmaceutical projects that will require a candidate with relevant experience i.e. who has seen large-scale (€100m +) projects through to completion. For this role, we need...