C&Q Leader Services

1 week ago

Cork, Ireland Biotalent Ltd Full time

Role Overview
We are seeking an experienced CQV (Commissioning, Qualification & Validation) Lead to support a GMP manufacturing facility in Cork.
The successful candidate will provide technical leadership and oversight for CQV activities, ensuring all systems, utilities, and equipment are commissioned and qualified in line with project timelines, industry standards, and regulatory requirements.
This is a 6-month contract role, ideally suited to a candidate with strong CQV leadership experience in GMP environments.
Key Responsibilities
Lead the planning, coordination, and execution of CQV activities across assigned systems and equipment.
Develop and review CQV deliverables, including protocols (IQ/OQ/PQ), test scripts, and summary reports.
Ensure compliance with GMP, FDA, EMA, and ICH guidelines throughout all qualification and validation phases.
Oversee contractor/vendor activities related to CQV execution.
Manage deviations, change controls, and CAPAs arising from CQV execution.
Interface with project engineering, quality, manufacturing, and automation teams to drive project progress.
Support regulatory inspections and audits, providing CQV expertise and documentation as required.
Ensure project milestones are met within scope, schedule, and budget.
Mentor junior CQV engineers and provide technical guidance.
Qualifications & Experience
Bachelor's degree (or higher) in Engineering, Science, or related discipline.
8+ years' experience in Commissioning, Qualification, and Validation within the pharmaceutical/biopharma industry.
Proven track record in leading CQV activities for GMP facilities, including utilities, process equipment, and/or cleanrooms.
Strong understanding of regulatory requirements (FDA, EMA, cGMP, ASTM E2500, ISPE guidelines).
Experience managing cross-functional teams and external vendors/contractors.
Excellent problem-solving, communication, and organizational skills.
Ability to work independently while driving project deliverables under tight deadlines.
#J-18808-Ljbffr

  • Project Engineer – E&I

    5 days ago

    Cork, Ireland Quanta Consultancy Services Ltd Full time

    OverviewProject Engineer–E&I - Ireland, Cork - 12 Months Initial ContractAre you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?This is a fantastic opportunity to work in a state-of-the-art facility in Cork.You will be joining a leading...

  • Intermediate Project Engineer

    4 weeks ago

    Cork, Cork, Ireland Controlled Environment Solutions Full time

    Job detailsCES are an established Engineering Service Provider working primarily within the Irish Pharmaceutical, Biotechnology and Medical Device sectors.Our expanding projects team require an Intermediate level HVAC Project Engineer to support a growing project portfolio.The role will involve elements of HVAC design, pricing, procurement, technical report...

  • C++ Engineer

    4 weeks ago

    Cork, Cork, Ireland Netapp, Inc. Full time

    Job SummaryNetApp, the data authority, empowers customers to manage data across clouds, data centers, and beyond.Engineers drive innovation in diverse fields, from healthcare to autonomous vehicles, using data analytics and AI.Join us to shape the future of data with ONTAP, the leading Storage Operating System, trusted by thousands worldwideJoin CFSG, a team...

  • C++ Algorithm Developer

    7 days ago

    Cork, Ireland Qualcomm Full time

    About The Role Join the Global SVE (System/Validation/Emulation) team at QCOM Technologies Inc, dedicated to delivering advanced solutions for the design of next-generation wireless products. As a leader in 5G innovation, Qualcomm is at the forefront of connectivity advancements that are transforming industries, generating employment opportunities, and...

  • I&C Engineer Ii

    3 weeks ago

    Cork, Ireland Ips-Integrated Project Services, Llc Full time

    OverviewAt IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.We are looking for a talentedI&C Engineer IIto join our team at our office located in Dublin or Cork, Ireland.In this role, you...

  • I&C Engineer II

    3 weeks ago

    Cork, Cork, Ireland IPS-Integrated Project Services, LLC Full time

    OverviewAt IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a talented I&C Engineer II to join our team at our office located in Dublin or Cork, Ireland. In this role,...

  • C++ Algorithm Developer

    3 weeks ago

    Cork, Ireland Qualcomm Full time

    About The RoleJoin the Global SVE (System/Validation/Emulation) team at QCOM Technologies Inc, dedicated to delivering advanced solutions for the design of next-generation wireless products.As a leader in 5G innovation, Qualcomm is at the forefront of connectivity advancements that are transforming industries, generating employment opportunities, and...

  • Mechanical Construction Supervisor

    3 weeks ago

    Cork, Ireland PM Group Full time

    Overview We have a requirement for a Mechanical Construction Supervisor to oversee major Pharmaceutical Construction Project's in West Cork. Our client is a Global Pharmaceutical company and the successful candidate will be working within our Managed Services division. The role is client-facing and requires the ability to inspire confidence throughout all...

  • Professional Services Business Systems Analyst

    1 week ago

    Cork, Ireland Proofpoint Full time

    Are you passionate about optimizingteam, and help shape the future of cybersecurity service delivery.At Proofpoint, we're dedicated to delivering cutting-edge cybersecurity solutions that protect organizations worldwide. As a leader in SaaS-based cybersecurity, we empower our clients through innovative products and exceptional service. Our Professional...

  • Professional Services Business Systems Analyst

    1 week ago

    Cork, Ireland Proofpoint Full time

    Are you passionate about optimizingteam, and help shape the future of cybersecurity service delivery.At Proofpoint, we're dedicated to delivering cutting-edge cybersecurity solutions that protect organizations worldwide.As a leader in SaaS-based cybersecurity, we empower our clients through innovative products and exceptional service.Our Professional...