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

Job Title: Design Assurance EngineerLocation: Galway, Ireland Department: Quality / Design Assurance Reporting To: Design Assurance Manager Type: Full-time, PermanentRole OverviewA highly motivated and experienced Design Assurance Engineer is sought to support the lifecycle of commercially released medical device products. This key role involves managing design changes, ensuring continued compliance with global standards, and supporting post-market activities such as complaint investigations.Key Responsibilities<ul><li>Provide design assurance input on sustaining engineering projects across the full product lifecycle.</li><li>Lead and execute product/material design changes in compliance with global regulatory and quality system requirements.</li><li>Assess changes for design, usability, sterilisation, biocompatibility, and clinical impact.</li><li>Support process changes in collaboration with R&amp;D and Manufacturing Engineering teams.</li><li>Maintain and update risk management files per ISO 14971 and FDA guidelines.</li><li>Generate and execute Design Verification (DV) plans, protocols, and reports.</li><li>Ensure compliance with design control requirements (FDA 21 CFR 820.30, ISO 13485).</li><li>Maintain design history files (DHF) and ensure full traceability of design documentation.</li><li>Support complaint investigations, root cause analysis, and implementation of CAPAs.</li><li>Stay informed on evolving regulatory requirements affecting product design and development.</li><li>Provide technical input into material specs, inspection criteria, drawings, and manufacturing documentation.</li><li>Contribute to regulatory submissions and audit preparation by providing design assurance documentation.</li><li>Collaborate across departments to document and implement product changes.</li><li>Champion continuous improvement initiatives within the design assurance function.</li><li>Mentor junior engineers when required.</li></ul>Qualifications &amp; Experience<ul><li>Bachelor&rsquo;s degree (Level 8 NFQ or equivalent) in Engineering, Science, or a related technical discipline.</li><li>2&ndash;3 years' experience in design assurance, quality engineering, or product development within the medical device sector.</li><li>Strong working knowledge of ISO 13485, ISO 14971, and FDA QSR.</li><li>Hands-on experience with:</li><ul><li>Design controls and verification activities</li><li>Biocompatibility and sterilisation validations</li><li>Risk management processes</li><li>Human factors and usability assessments</li></ul><li>Experience with post-market quality processes, including complaint handling and CAPA.</li><li>Demonstrated ability to work independently on moderately complex projects with general supervision.</li><li>Strong analytical, communication, and documentation skills.</li><li>Ability to manage multiple priorities in a dynamic, fast-paced environment.</li><li>Effective team player with the ability to influence cross-functional collaboration.</li></ul>

Senior Design Assurance Engineer

HVAC Validation Engineer - Waterford&nbsp; Our client is hiring an onsite HVAC Validation Engineer with CTCB-I Professional Certification to join their Technical Quality team, supporting a key pharmaceutical client in Co Waterford. This role ensures compliance with GMP standards across cleanroom and lab environments. Key Responsibilities:<ul><li>HEPA filter testing, airflow visualization, non-viable particulate monitoring.</li><li>Validation of cleanroom environments, LAFs, BSCs, fume cupboards and containment suites.</li><li>Temperature, humidity and pressure control verification.</li><li>Commissioning &amp; test balancing (TAB), system optimization, troubleshooting.</li><li>Audit support and GMP documentation.</li></ul>Qualifications &amp; Experience: <ul><li>CTCB-I Professional Certification (mandatory).</li><li>3+ years in cleanroom validation within pharma/biotech/medical devices.</li><li>Strong knowledge of cGMP, ISO standards and validation protocols.</li><li>Compliance with Health &amp; Safety legislation. </li></ul>For further information on this role please contact Regina Carroll on +353 86 0100 903 or email <a href="mailto:jobs@hero.ie">jobs@hero.ie </a> 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 based on 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

HVAC Validation Engineer

<aside class="job-preview__other-job-details">Job Title:&nbsp;Wet Process Engineer Location:&nbsp;Wexford, Ireland Department:&nbsp;Engineering / Manufacturing Reports To:&nbsp;Process Engineering Manager Contract Type:&nbsp;Full-Time / PermanentAbout the RoleWe are looking for a highly experienced Wet Process Engineer to join our team on a contract basis as a Subject Matter Expert (SME). You will play a critical role in overseeing and optimising a specialised wet processing line, which includes:<ul><li>Dissolving powders into liquid suspension</li><li>Pasteurising formulations at temperatures up to 85&deg;C</li><li>Injecting oil into the solution</li><li>High-pressure homogenisation</li><li>Final drying through spray drying technology</li></ul>This role is ideally suited for a technically strong process engineer with hands-on experience in thermal processing and complex liquid-to-powder systems in the food or pharma sectors.Key Responsibilities<ul><li>Lead process design, optimisation, and troubleshooting from powder dissolution through spray drying</li><li>Define, monitor, and adjust critical process parameters to ensure product quality and system stability</li><li>Work closely with operations, automation, and quality teams to deliver improvements in throughput, yield, and consistency</li><li>Support process commissioning, validation, and technical documentation</li><li>Implement best practices in hygiene, safety, and regulatory compliance</li><li>Provide subject matter expertise during audits, risk assessments, and cross-functional investigations</li></ul>Qualifications &amp; Experience<ul><li>Degree in Chemical Engineering, Process Engineering, or equivalent</li><li>Minimum of 5 years&rsquo; experience in a wet process environment (ideally food, dairy, or pharmaceutical)</li><li>Expertise in thermal processing, spray drying, and high-pressure pumping systems</li><li>Strong problem-solving and analytical skills, with experience in data analysis and process diagnostics</li><li>Ability to work independently while engaging collaboratively with internal teams</li><li>Must have the right to work in Ireland; this is a contract role and does not offer visa sponsorship</li><li>Pasteurising Experience</li></ul>Contract Details<ul><li>Duration:6-12 Months</li><li>Start Date: Immediate</li><li>Location: Southeast Ireland with potential for hybrid flexibility</li><li>Rate: Competitive day rate, commensurate with experience</li></ul>To Apply: Please send your CV and a short cover note outlining your availability and relevant experience to consulting@hero.ie</aside>

Wet Process Engineer

Senior Automation Engineer Our client are seeking a Senior Automation Engineer to join our team in Cavan. In this pivotal role, you will help shape and implement a robust automation strategy for the site, working closely with the Site Engineering Manager, Divisional Engineering, IT, and other key stakeholders. This is a highly collaborative position requiring strong technical expertise, project management, and stakeholder engagement skills. Key Responsibilities: <ul><li>Support the development and execution of the site&rsquo;s Operational Technology (OT) strategy and roadmap.</li><li>Drive standardisation and best practices in automation and digital systems (Industry 4.0, Smart Factory).</li><li>Govern OT elements of projects to ensure alignment with site strategy and standards.</li><li>Oversee lifecycle management of OT infrastructure, applications, and support services.</li><li>Support and develop automation engineering talent within the site team.</li><li>Align with other sites to adopt and share network-wide best practices.</li></ul>Requirements: <ul><li>Bachelor&rsquo;s degree in Engineering or Computer Science.</li><li>5+ years' experience in a manufacturing or operations technology function.</li><li>Proven experience with automated systems, system lifecycle management, and compliance (GAMP, cGMP, 21 CFR Part 11).</li><li>Familiarity with Siemens PLCs, SCADA systems, OSIsoft Pi historians is highly desirable.</li><li>Strong project management skills.</li><li>People management experience is preferred but not essential.</li></ul> Skills &amp; Competencies: <ul><li>Strong communication and stakeholder management.</li><li>Ability to manage third-party vendors and remote service providers.</li><li>Problem-solving mindset with a continuous improvement approach.</li><li>Adaptable, collaborative, and focused on delivering results.</li></ul>

Hey there! As an experienced recruitment consultant with a solid track record in the industry. I've got the skills and expertise to make those perfect connections. My experience spans various industries, such as medical devices, pharmaceuticals, Fintech, Medtech, IT, and automotive. Talk about a wide range! My passion for learning knows no bounds. I'm always seeking new knowledge and continuously studying to stay ahead of the game. Because let's face it, staying up-to-date is crucial in this fast-paced world.
As someone who values hard work, I understand the importance of finding a place that respects not only your professional expertise but also who you are as a person. It's all about finding that perfect match where you feel valued and appreciated.
Outside of work I love music and festivals. You might be wondering how that ties into my recruitment work, but here's the thing&mdash;music and festivals are all about creating incredible experiences, bringing people together, and fostering a sense of community. These values align perfectly with my approach to recruitment. I believe in creating meaningful connections, understanding the unique qualities and passions of candidates, and finding the perfect fit where they can thrive and contribute.
If you have any questions about the roles I'm advertising or need assistance with your hiring needs, don't hesitate to reach out. I'm here to guide you, connect the dots, and make your recruitment journey smooth and successful.

Job Details

Project Manager - Automation

Recruitment Consultant

Project Manager - Automation

Similar Jobs

Change Control Lead

Project Manager - MedTech

Manufacturing Engineer II

Senior Design Assurance Engineer

HVAC Validation Engineer

Wet Process Engineer

Search Jobs

Match my CV