An exciting opportunity is available for an experienced Isolator Validation Engineer to join a high-performing team in a dynamic cGMP regulatory environment. This role focuses on the qualification of isolator systems, including Airflow Visualisation, Vaporised Hydrogen Peroxide (VHP), and HVAC components.Key Responsibilities:As an Isolator Validation Engineer, you will:<ul><li>Design, author, review, approve, and execute qualification and validation documentation.</li><li>Develop and execute cycle development studies in alignment with internal approval processes.</li><li>Support and manage change control documentation and execution.</li><li>Troubleshoot and resolve technical issues during validation studies.</li><li>Collaborate closely with Production, Maintenance, and Quality teams during validation activities.</li><li>Provide technical input into deviations and quality investigations.</li><li>Conduct root cause analysis using standard tools and methodologies.</li><li>Apply Lean Six Sigma principles to drive continuous improvement.</li><li>Represent the validation team in cross-functional projects and global forums.</li><li>Ensure compliance with all regulatory requirements, GMP standards, and company procedures.</li><li>Complete risk assessments, address corrective actions, and support inspections and audits.</li><li>Contribute to a culture of safety, compliance, and performance.</li><li>Perform additional duties as required.</li></ul>Required Experience &amp; Skills:To succeed in this role, you should have:<ul><li>Direct experience with Isolator Airflow Visualisation, VHP, and HVAC Qualification.</li><li>Solid background in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience in writing and executing validation protocols, reports, and change controls.</li><li>Proven ability to lead validation efforts independently and as part of a team.</li><li>Knowledge of deviation management and CAPA processes.</li><li>Understanding of regulatory standards applicable in Ireland, the EU, and internationally.</li><li>Strong analytical skills, with the ability to interpret complex data and identify trends.</li><li>Proficiency in Microsoft Office and relevant job-related applications.</li><li>Excellent communication, collaboration, and documentation skills.</li></ul>Preferred Qualifications &amp; Skills:The following additional experience is advantageous but not necessary:<ul><li>Filter Validation</li><li>Container Closure Integrity (CCI) Qualification</li><li>Shipping Qualification</li><li>Equipment Lifecycle Validation</li><li>Autoclave / SIP Sterilisation Validation</li><li>Dry Heat Sterilisation</li><li>Cleaning Validation</li><li>Controlled Temperature Equipment Qualification</li><li>Vial and Syringe Processing Technologies</li><li>Knowledge of DeltaV, Pi System, or other automation/data systems</li><li>Project Management skills or certification</li></ul>Education &amp; Qualifications:<ul><li>A relevant technical qualification in Applied Pharmaceutical, Biological, or Chemical Sciences, or Engineering.</li></ul>Apply today!Our Vision:&nbsp;To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters For further information on this role please contact&nbsp;R&oacute;is&iacute;n Vaughan&nbsp;on&nbsp;086 440 3742 /&#8239;consult@hero.ie Check out all our open jobs on our HERO Recruitment website -&nbsp;<a href="https://hero.ie/">HERO Recruitment: Leading STEM Recruitment Agency</a>&#8239; Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Isolator Validation Engineer

Job Purpose:Reporting to the Maintenance Manager, the Change Control Lead is responsible for achieving the deliverables involved in the planning and execution of all change control activities for the BACE project. The role is accountable for compliance with regulatory requirements, ensuring that the site meets all change control requirements and that systems are audit-ready for both customer and agency inspections. The incumbent promotes GMP awareness at the Ballydine site, providing feedback and training to the BACE team on improvements that can be made to enhance GMP and compliance as appropriate.Key Responsibilities:<ul><li>Ownership and management of changes associated with large strategic projects. Changes may be related to processes such as equipment, automation, and supply chain, or other technical functions as required.</li><li>Responsible for initiation, ownership, and management of changes through the change control systems.</li><li>Preparation and progression of GMP and Non-GMP changes in IPI, Vault QMS, and Enablon systems.</li><li>Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups throughout the life cycle of relevant changes.</li><li>Obtain approval for change from the relevant review board.</li><li>Impact assessment for relevant changes.</li><li>Liaise with stakeholders for impact assessment and task identification.</li><li>Align system release strategy with stakeholders/operations.</li><li>Identify and implement process optimization opportunities where they arise (e.g., hierarchy or dependency optimization, material control strategies).</li><li>Maintain accurate task scheduling per project requirements and minimize the number of overdue tasks through schedule management.</li><li>Engage with the tier process to escalate changes or tasks that are off track.</li><li>Conduct safety and quality walkdowns, as required.</li></ul>Core Competencies:Technical:<ul><li>Understanding of unit operations and plant equipment</li><li>Understanding of validation (process and cleaning)</li><li>High-level understanding of regulatory requirements related to change control</li><li>Understanding of quality policies and procedures</li><li>Understanding of GMP and GDP practices</li><li>Knowledge of safety and environmental procedures</li><li>Proficiency in using digital systems for fully digitalised change control execution</li><li>Familiarity with project life cycle delivery</li></ul>Business:<ul><li>Excellent communication skills, both oral and written</li><li>Project management skills</li><li>Data collation skills</li><li>Decision-making and problem-solving skills</li><li>Strong interpersonal skills</li></ul>Leadership:<ul><li>Strong customer service orientation</li><li>Collaboration skills</li></ul>Key Requirements:<ul><li>Ideally, candidates should have a strong emphasis on change control documentation, a GMP/GDP background, and a degree in a science and/or engineering-based discipline</li><li>Minimum of 2 &ndash; 6 years&rsquo; experience</li><li>Experience working in a project environment</li><li>Hands-on attitude, specifically carrying out change controls to a very high standard</li><li>Excellent oral and written communication skills in English</li><li>High level of customer orientation/understanding</li><li>Strong time management and ability to deliver to timelines</li><li>Attention to detail and strong knowledge of GDP requirements</li></ul> Apply today!Our Vision:&nbsp;To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters For further information on this role please contact&nbsp;R&oacute;is&iacute;n Vaughan&nbsp;on&nbsp;086 440 3742 /&#8239;consult@hero.ie Check out all our open jobs on our HERO Recruitment website -&nbsp;<a href="https://hero.ie/">HERO Recruitment: Leading STEM Recruitment Agency</a>&#8239; Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Change Control Lead

Project Manager &ndash; MedTech | KildareLocation:&nbsp;Kildare, IrelandIndustry:&nbsp;MedTech / Medical DevicesFunction:&nbsp;Project Management / Engineering / OperationsAre you a dynamic Project Manager ready to lead cutting-edge projects in the MedTech space? Our client, a leading medical technology company based in Kildare, is seeking an experienced&nbsp;Project Manager&nbsp;to drive the successful development, commercialisation, and delivery of new and existing projects across cross-functional teams.Key Responsibilities:<ul><li>Plan, schedule, and manage project activities in alignment with business and quality objectives.</li><li>Lead and coordinate cross-functional project teams, ensuring timely delivery of milestones.</li><li>Develop and maintain strong relationships with stakeholders through structured communication plans.</li><li>Track project progress, costs, and budgets; provide accurate status updates and ensure ROI targets are met.</li><li>Drive compliance with regulatory standards (e.g. GMP, ISO13485) and internal quality management systems.</li><li>Coach and mentor team members on project management best practices.</li><li>Proactively manage project risks, issues, and change requests.</li><li>Conduct post-project reviews and contribute to continuous improvement initiatives.</li><li>Ensure compliance with all company policies, including H&amp;S, financial controls, and QMS requirements.</li></ul>Your Profile:<ul><li>Bachelor&rsquo;s degree (or equivalent) in Engineering, Project Management, or related field;&nbsp;PMP certification preferred.</li><li>Extensive experience managing full project life cycles in a GMP-compliant, high-volume manufacturing environment.</li><li>Proven track record in budget management, process improvement, and project delivery.</li><li>Strong leadership, interpersonal, and stakeholder management skills.</li><li>Excellent communication abilities &ndash; both verbal and written.</li><li>Solid understanding of QMS principles (ISO13485 preferred).</li><li>Proficiency in Microsoft Office, Gantt charts, and other project tracking tools.</li><li>Detail-oriented with excellent analytical and organisational skills.</li><li>Self-motivated team player, capable of managing multiple priorities in a fast-paced setting.</li><li>Flexibility to travel occasionally as required.</li></ul>Why Join Us?<ul><li>Join an innovative MedTech company making a real difference in patient lives.</li><li>Be part of a collaborative, forward-thinking team.</li><li>Gain exposure to global projects and continuous learning opportunities.</li><li>Enjoy a competitive salary and comprehensive benefits package.</li></ul>

Project Manager  - MedTech

Job Title: Manufacturing Engineer II x3 (Projects) Location: Clonmel, IrelandOverview Join a world-leading organisation at the forefront of innovation in medical device manufacturing. As a Manufacturing Engineer II, you&rsquo;ll drive efficiency and quality within production, tackle complex engineering challenges, and play a pivotal role in integrating cutting-edge processes and products. This is your opportunity to advance your career in a thriving, supportive, and globally recognised company based in the vibrant community of Clonmel, offering an outstanding quality of life amidst Ireland&rsquo;s scenic beauty and rich heritage.Key Responsibilities<ul><li>Process Optimisation: Streamline production operations by monitoring equipment, tools, and processes, addressing performance issues to ensure optimal output, product quality, and cost efficiency.</li><li>Product and Process Development: Lead technical initiatives to enhance current processes and drive innovation in next-generation programmes, aligning with strategic goals.</li><li>Problem Solving and Analysis: Apply advanced engineering principles to solve complex challenges, develop novel solutions, and drive breakthroughs in manufacturing technology.</li><li>Reporting and Communication: Prepare detailed reports, share insights through presentations, and communicate findings effectively with internal stakeholders.</li><li>Leadership and Collaboration: Mentor colleagues by sharing technical expertise, guiding project teams, and setting clear goals and objectives for collaborative success.</li><li>Quality Commitment: Demonstrate unwavering dedication to product quality and patient safety by adhering to quality system policies and regulatory standards.</li><li>The predominant function for these Engineers will be executing validations on duplicate sets of equipment. </li></ul> What We&rsquo;re Looking For<ul><li>Experience and Knowledge:<ul><li>Strong foundation in engineering principles, concepts, and practices.</li><li>Experience in manufacturing or process engineering roles, preferably within the medical device or regulated industry.</li><li>Working knowledge of industry and business practices.</li></ul></li><li>Skills and Abilities:<ul><li>Problem-solving mindset with the ability to address complex issues and implement effective solutions.</li><li>Excellent communication skills to present ideas and collaborate across teams.</li><li>Capacity to manage tasks independently while contributing to team objectives.</li><li>Equipment Validation Experience.</li></ul></li></ul>Why Choose This Role in Clonmel? Clonmel offers the perfect blend of professional growth and personal wellbeing, with a supportive community, a vibrant local culture, and access to some of Ireland&rsquo;s most stunning landscapes.Ready to Apply? Take the next step in your career by joining a company committed to excellence, innovation, and making a difference in people&rsquo;s lives. Apply today and become part of our success story in Clonmel, Ireland! For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email&nbsp;<a href="mailto:consulting@hero.ie">consulting@hero.ie</a>&nbsp;Check out all our open jobs on our HERO Recruitment website &ndash; https://www.hero.ie/Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Manufacturing Engineer II

<h1 data-start="254" data-end="341">Discover R&amp;D Engineering Jobs in Cork&rsquo;s Pharma, Biotech &amp; Manufacturing Sectors</h1>
Looking for R&amp;D engineering roles in one of Ireland&rsquo;s most advanced STEM hubs? Cork is a national centre of excellence for innovation in pharmaceuticals, biotechnology, advanced manufacturing, and process development. At HERO Recruitment, we connect experienced engineers and ambitious graduates with leading R&amp;D opportunities across the Cork region.
<h2 data-start="700" data-end="746">In-Demand R&amp;D Engineering Jobs in Cork</h2>
We recruit for a wide range of research and development roles in Cork, including:
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Product Development Engineer &ndash; Pharma &amp; Biotech
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R&amp;D Process Engineer &ndash; Manufacturing &amp; Scale-Up
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Design Control &amp; Innovation Engineers
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Validation and Process Development Engineers
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Technical Project Leads &amp; Principal R&amp;D Engineers
</li>
</ul>
<a href="https://www.hero.ie/jobs/?query=engineering+Cork&amp;role_type=" data-start="1079" data-end="1144">Explore All Engineering Jobs in Cork</a>
<h2 data-start="1151" data-end="1202">Why Cork is a Powerhouse for R&amp;D in Ireland</h2>
Cork is home to:
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Global pharmaceutical and biopharma companies
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A growing medtech and diagnostics presence
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Advanced manufacturing and process optimisation hubs
</li>
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Academic-industry partnerships through MTU and UCC
</li>
</ul>
HERO Recruitment plays a vital role in placing R&amp;D professionals into long-term roles and <a href="https://www.hero.ie/seo-landing-pages/stem-contracting-services-in-ireland-hero-recruitment/" data-start="1514" data-end="1640">STEM contracting opportunities</a> across these industries.
Want to see what&rsquo;s happening across Ireland? Explore <a href="https://www.hero.ie/jobs/?query=Research+and+development&amp;role_type=" data-start="1720" data-end="1818">R&amp;D Engineering Jobs Ireland</a> for broader market insights.
<h2 data-start="1854" data-end="1900">Companies Hiring R&amp;D Engineers in Cork</h2>
We partner with some of the world&rsquo;s most innovative employers, including:
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Biopharma and pharmaceutical leaders
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Medical device manufacturers expanding into Cork
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Process engineering and product scale-up specialists
</li>
<li data-start="2122" data-end="2173">
R&amp;D hubs focused on automation and product safety
</li>
</ul>
See how we deliver results for clients on our <a href="https://www.hero.ie/about-us/">Case Studies </a>page.
<h2 data-start="2279" data-end="2323">Why Choose HERO Recruitment in Cork?</h2>
With a strong local presence and deep STEM knowledge, HERO offers:
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20+ years of engineering recruitment in Ireland
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Strong links with Cork-based employers
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Permanent, contract, and project-based job options
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Quick hiring process and ongoing support
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Help for professionals relocating to Ireland
</li>
</ul>
Looking for short-term roles? Explore our <a href="https://www.hero.ie/seo-landing-pages/stem-contracting-services-in-ireland-hero-recruitment/" data-start="2670" data-end="2786">Contracting Services</a>.
<h2 data-start="3099" data-end="3137">FAQs &ndash; R&amp;D Engineering in Cork</h2>
Q: Which industries offer the most R&amp;D jobs in Cork? A: Pharmaceuticals, biotechnology, and advanced manufacturing lead the way.
Q: Are there contract R&amp;D jobs in Cork? A: Yes, we support both permanent and contracting roles in R&amp;D across Cork.
Q: Can HERO support relocation to Cork for an R&amp;D role? A: Absolutely &mdash; we assist STEM professionals from the EU and beyond with relocation.
<h2 data-start="3551" data-end="3598">Ready to Start Your R&amp;D Career in Cork?</h2>
Submit your CV or connect with our expert engineering recruiters based in Cork.
 <a href="https://www.hero.ie/contact/" data-start="3727" data-end="3780">Contact Our Cork Team</a>

R&D Engineering Jobs Cork | Innovation Careers in Pharma & Manufacturing | HERO Recruitment

Discover R&D Engineering Jobs in Cork’s Pharma, Biotech & Manufacturing Sectors

In-Demand R&D Engineering Jobs in Cork

Why Cork is a Powerhouse for R&D in Ireland

Companies Hiring R&D Engineers in Cork

Why Choose HERO Recruitment in Cork?

FAQs – R&D Engineering in Cork

Ready to Start Your R&D Career in Cork?

Engineering Jobs

Isolator Validation Engineer

Change Control Lead

Project Manager - MedTech

Manufacturing Engineer II