Job Title: Project Engineer (Pharmaceutical Projects) Location: County Tipperary, Ireland
Are you a passionate and experienced Project Engineer looking to take your career to the next level? Our client, a leading pharmaceutical company, is seeking a dynamic Project Engineer to join their Site Projects Group in Ballydine. This exciting opportunity will allow you to lead capital and expense projects within a high-performing team, driving innovation and excellence in project delivery. In addition to a rewarding career, you&rsquo;ll enjoy the exceptional quality of life that County Tipperary offers, with its welcoming community, stunning landscapes, and vibrant cultural scene.
Key Responsibilities:
Project Management &amp; Execution
<ul>
<li>Develop and execute detailed project plans, ensuring adherence to schedules, budgets, and performance targets.</li>
<li>Manage the design, commissioning, qualification, and overall project lifecycle, working closely with cross-functional teams, contractors, and suppliers.</li>
<li>Monitor and report on project progress, ensuring timely delivery and meeting project deliverables.</li>
</ul>
Collaboration &amp; Safety
<ul>
<li>Work collaboratively with site teams to foster a culture of safety and compliance, promoting the highest standards of site safety throughout the project lifecycle.</li>
<li>Support the coordination of multiple capital projects simultaneously, maintaining quality and compliance with company standards.</li>
</ul>
Construction Oversight
<ul>
<li>Oversee on-site construction activities, particularly during peak times and staff leave periods, ensuring smooth operations and timely project completion.</li>
</ul>
Key Qualifications &amp; Skills:
<ul>
<li>Education: Bachelor's degree in Engineering, ideally in Chemical, Mechanical, Electrical, or Project Management disciplines.</li>
<li>Experience: A minimum of 5 years&rsquo; experience in the pharmaceutical or biopharmaceutical industry, with proven expertise in engineering, maintenance, and project management.</li>
<li>Strong knowledge of the project lifecycle from concept to qualification, with a track record of delivering projects on time and within budget.</li>
<li>Familiarity with engineering project management tools and financial management, including budgeting and cost control.</li>
<li>Experience working in a regulated GMP environment, with a commitment to the highest standards of engineering and compliance.</li>
<li>Technical Skills: Experience with SAP (preferred but not essential).</li>
<li>Soft Skills: Exceptional communication, negotiation, organisational, and problem-solving skills, with the ability to work independently or as part of a team.</li>
</ul>
Why Choose County Tipperary? County Tipperary offers a unique blend of professional growth and personal fulfilment, with its rich cultural heritage, scenic beauty, and strong sense of community, making it an ideal place to live and work. 
&ldquo;Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters&nbsp;
Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a>  &nbsp;
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.&nbsp;
 &nbsp;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.&rdquo;&nbsp;
&nbsp;

Project Engineer 

This role is positioned within the engineering team based in Galway. The site provides testing and other technical services to the medical device and pharma industries.
The role requires the use of project management skills, high technical aptitude and extensive on-job experience. They routinely interface with customers therefore a high commercial awareness and interpersonal skill is essential.
Authorised to perform specific activities including:
a) develop, modify, verify and validate methods
b) analysis of results, statements of conformity and opinions / interpretations
c) report, review and authorize results
Duties
<ul>
<li>Manages multiple complex customer testing projects simultaneously</li>
<li>Leads device and packaging testing projects for medical device and pharma customers</li>
<li>Interfaces with Customers and sales team to assess feasibility and costings of new projects</li>
<li>Develops and agrees project plans, test protocols and test methods with Customers</li>
<li>Coordinates staff and schedules equipment resources to execute testing and reporting of results</li>
<li>Designs and documents test jigs and fixtures</li>
<li>Working with the validation team to conduct Test Method Validation studies</li>
<li>Assess equipment specifications and suitability for test method</li>
<li>Develops URS for laboratory equipment procurement</li>
<li>Support Quality team with investigations, procedure updates and audits</li>
<li>Engage in lean and continuous improvements onsite</li>
</ul>
Education
<ul>
<li>Bachelor's Degree</li>
</ul>
Required Experience
<ul>
<li>Medical device verification and validation / regulatory submission project experience</li>
<li>Customer facing experience</li>
<li>Device verification and validation / regulatory submission project experience</li>
<li>Proven project management track record</li>
<li>CAD and Minitab software experience an advantage</li>
</ul>
&nbsp;

Development Engineer

Manufacturing Process Engineer Dedicated to Stoma Care 
Summary
The Manufacturing Process Engineer will report to the Manufacturing Engineering Supervisor and will primarily serve Manufacturing Operations. This role will collaborate with Global Engineering (GE), New Product Development (NPD), Research and Development (R&amp;D), Quality Assurance (QA), and Supply Chain (SCM) to fulfill its responsibilities.
This individual will execute process engineering activities associated with developing new and existing manufacturing capacities. The role will leverage existing manufacturing technologies to aid in developing new technologies, with the goal of implementing higher-output systems while maintaining product quality. Responsibilities include leading process improvement projects, guiding project team members, and overseeing overall process development, including liaising with technology partners to achieve desired outcomes.
Responsibilities:
Key responsibilities for the Manufacturing Process Engineer role include:
<ul>
<li>New Process Implementation: Responsible for the timely implementation of new manufacturing processes in the designated Value Stream area. Projects may include capacity increases, new product introductions, and cost reduction initiatives involving highly automated production equipment. This role will lead cross-functional teams to achieve objectives, including creating User Requirements (URS), Functional Design Specifications (FDS), and obtaining Capital Approval, as well as conducting design reviews using FMEA tools.</li>
<li>Project Planning &amp; Tracking: Develop and monitor project plans while ensuring formal communication of progress. Maintain budgetary control of projects.</li>
<li>New Process Concept Development: Oversee the development of concepts for fully automated manufacturing systems, collaborating with technology partners, completing proof of principle via prototyping key bottleneck areas, and developing high-level concepts that meet customer requirements.</li>
<li>Process Improvements: Identify and implement process and product improvements within the assigned area.</li>
<li>New Product Introduction: Support the timely introduction of new products or product upgrades in the designated Value Stream area, including the development of product costs (COGS).</li>
<li>Process Qualification: Support qualification of new products/processes to ensure compliance with quality standards by executing protocols.</li>
<li>Safety/Risk Assessments: Ensure safety compliance in the designated area and support the timely completion of risk assessments.</li>
</ul>
Skills:
<ul>
<li>Leadership:</li>
</ul>
<ul>
<li style="list-style-type: none;">
<ul>
<li>Mentor teams or individuals, utilizing direct or indirect influence techniques to support the needs of internal stakeholders.</li>
<li>Coordinate project activities across multi-functional and geographically diverse teams to meet deliverables.</li>
<li>Frequently demonstrate technical and professional expertise on medium to high-profile projects.</li>
</ul>
</li>
<li>
Project Management:
<ul>
<li>Break down technical projects into manageable tasks using systematic techniques.</li>
<li>Secure resources, provide direction to team members, assign tasks appropriately, and ensure that commitments are met.</li>
<li>Monitor project progress, anticipate potential problems, develop solutions proactively, and use clear metrics to report progress to management.</li>
</ul>
</li>
<li>
Process Development:
<ul>
<li>Develop process concepts and alternatives, and prepare formal written justifications for financial authorization.</li>
<li>Lead or coordinate the design and testing of prototype processes for proof of concept work.</li>
<li>Create process specifications, requests for quotations, factory acceptance plans, validation plans, and other relevant documentation to support process introductions.</li>
<li>Foster and manage vendor relationships to support process introductions.</li>
</ul>
</li>
<li>
Business Acumen:
<ul>
<li>Understand accounting principles, capital and expense planning, cost center reporting, and tools to assess project and departmental performance.</li>
<li>Apply sound business principles to evaluate alternatives and provide technical direction.</li>
</ul>
</li>
</ul>
Education:
<ul>
<li>Bachelor&rsquo;s Degree in an Engineering discipline, preferably Mechanical, Plastics, or Electrical/Controls Engineering.</li>
<li>A Master&rsquo;s degree in project management, manufacturing systems, or equivalent is an advantage.</li>
<li>ASQ Green/Black Belt Certification is a plus.</li>
</ul>
Technical Knowledge:
<ul>
<li>Project Management training or qualifications.</li>
<li>Proficiency in 2D/3D CAD.</li>
<li>Understanding of pneumatic circuits and controls.</li>
<li>Familiarity with DOE techniques, statistical analysis tools, and/or DFM principles.</li>
<li>Minimum of 3 years of post-qualification experience in general engineering or project management.</li>
</ul>
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 Process Engineer

<h3>Process Engineer</h3>
Location: Carlow, Ireland
Join a Global Leader in Pharmaceutical Innovation As a Process Engineer, you'll be at the heart of cutting-edge manufacturing processes in a dynamic, fast-paced environment. Working with a world-class team, you will support the development and execution of critical manufacturing operations, ensuring the highest standards of compliance, safety, and reliability. This is your chance to make a real impact within the pharmaceutical industry while advancing your career with a leader in the field.
Job Purpose The Process Engineer will be responsible for driving the generation, review, and approval of essential GMP documentation, including Quality Notifications, CAPA records, SOPs, Standard Work Instructions, and change controls. The role ensures that all activities are aligned with company requirements to maintain compliance, safety, and a reliable supply chain for customers.
Principal Accountabilities
<ul>
<li>
Support Manufacturing: Collaborate closely with manufacturing teams by generating and expediting process investigations for non-GMP activities. Act as the go-to technical expert for MES (Manufacturing Execution System) functionalities, ensuring seamless integration and support for production.
</li>
<li>
Documentation Management: Serve as a documentation expert, overseeing the creation, review, and approval of SOPs, SWIs, and training materials. Lead document system workflow expeditions, ensuring efficient management of change controls and batch release documents.
</li>
<li>
Process Improvement: Investigate and resolve system issues using methodologies like FMEA, Fishbone diagrams, and the 5 Why&rsquo;s. Lead the implementation of corrective and preventive actions (CAPA), ensuring continuous improvement in manufacturing processes.
</li>
<li>
Compliance and Quality: Uphold the highest standards of cGMP compliance, adhering to Merck&rsquo;s global policies and industry regulations. Ensure all production activities and documentation align with local and international codes and standards.
</li>
<li>
Collaboration and Training: Work cross-functionally with various departments to foster a culture of safety and compliance. Assist with the management and delivery of IPT training to enhance team capabilities.
</li>
<li>
Customer-Focused Solutions: Address customer complaints and manage change controls swiftly to support ongoing production and maintain client satisfaction.
</li>
</ul>
Skills and Knowledge
Minimum Education:
<ul>
<li>A Bachelor's degree (or higher) in Science, Engineering, or a related Technical discipline is preferred.</li>
</ul>
Experience:
<ul>
<li>Demonstrated expertise within a manufacturing environment, ideally within GMP settings.</li>
<li>Strong SAP knowledge, Microsoft Office proficiency, and experience with job-related software systems.</li>
</ul>
Core Competencies
Technical Expertise:
<ul>
<li>SAP knowledge and hands-on experience.</li>
<li>Understanding of international regulatory requirements and industry codes.</li>
<li>Competency in process validation, equipment management, and sterile filling processes.</li>
<li>Experience with Lean Six Sigma methodology is highly desirable.</li>
</ul>
Business Skills:
<ul>
<li>Excellent communication and interpersonal skills, with the ability to work effectively across all levels of the organisation.</li>
<li>Proven ability to coach, develop, and lead teams, fostering a collaborative and goal-oriented work environment.</li>
<li>Strong analytical, problem-solving, and risk management skills.</li>
<li>Effective time management and organisational capabilities, with attention to detail and multi-tasking abilities.</li>
</ul>
Leadership:
<ul>
<li>Demonstrates a customer and patient-focused approach.</li>
<li>Acts with integrity, courage, and transparency.</li>
<li>Takes decisive actions to drive results and build talent within the team.</li>
</ul>
Reports To: Operations Coach (Manufacturing Support)
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.

Process Engineer I

<h3>Mechanical Technician III</h3>
Location: Carlow, Ireland
Join an Innovative, State-of-the-Art Manufacturing Facility Are you ready to take your mechanical expertise to the next level? a premier site dedicated to vaccine production, the Mechanical Technician III plays a pivotal role in maintaining, troubleshooting, and enhancing advanced process equipment. This cutting-edge facility integrates top-tier technology and fosters a collaborative work environment, making it the perfect place to grow your career while contributing to life-saving pharmaceutical production.
Job Purpose The Mechanical Technician III will report to the Maintenance Lead and will be responsible for maintaining and troubleshooting critical process devices, instrumentation, and controls. This role ensures the seamless operation of essential manufacturing equipment, guaranteeing consistent compliance with safety standards and a reliable supply chain for our customers.
Key Responsibilities
<ul>
<li>
Technical Support &amp; Maintenance: Provide advanced technical support to production teams by maintaining, installing, and modifying equipment. Perform detailed maintenance, preventive tasks, calibrations, and troubleshooting to optimise machinery performance.
</li>
<li>
Process Equipment Operation: Operate and clean process equipment as required, ensuring that production runs smoothly and adheres to Good Manufacturing Practices (cGMP).
</li>
<li>
Preventive Maintenance &amp; Troubleshooting: Perform preventive and reactive maintenance on process and production equipment to ensure continuous, reliable operation. Lead Total Productive Maintenance (TPM) initiatives to enhance equipment longevity and efficiency.
</li>
<li>
Shutdown &amp; Downtime Management: Plan and manage equipment shutdowns to minimise downtime, ensuring that all necessary resources are in place for smooth operations.
</li>
<li>
Maintenance Documentation: Keep accurate records of all maintenance activities, upgrades, and repairs. Document preventative maintenance and equipment changes, ensuring a well-documented repair history for future reference.
</li>
<li>
System Operation &amp; Monitoring: Operate and monitor production equipment using MES/DCS and PLC systems, ensuring optimal uptime and facilitating continuous process improvements through Lean Principles.
</li>
<li>
Complex System Troubleshooting: Operate, troubleshoot, and repair advanced systems such as Autoclaves, Glassware Washers, Single-use Mixers, HVAC systems, and filling and inspection lines, ensuring compliance in a highly regulated, cGMP environment.
</li>
<li>
Continuous Improvement: Lead and participate in continuous improvement initiatives, including repairs, system upgrades, preventative maintenance, and investigations into equipment failures. Utilise root cause analysis tools such as FMEA, Fishbone diagrams, and 5 Why&rsquo;s to resolve machine issues and implement corrective actions.
</li>
<li>
Vendor Coordination: Liaise with vendors for spare parts and equipment upgrades, providing technical data to ensure smooth asset management and equipment functionality.
</li>
<li>
Documentation &amp; Training: Participate in writing, revising, and rolling out operational procedures and training materials, ensuring all work aligns with regulatory standards and company policies.
</li>
</ul>
Skills and Qualifications
<ul>
<li>
Education &amp; Experience: Time-served MAMF Apprenticeship or equivalent Certificate/Diploma in Engineering or a related discipline. Previous experience in a cGMP environment and regulated pharmaceutical production is essential.
</li>
<li>
Technical Expertise: Strong hands-on experience with preventive/reactive maintenance and a deep understanding of mechanical, electrical, instrumentation, and pneumatic systems.
</li>
<li>
Technology Skills: Proficiency in Microsoft Office and job-related software applications, with strong communication skills in discussing technical subjects.
</li>
</ul>
Why Carlow? Carlow offers an outstanding quality of life, blending a welcoming community with rich history, culture, and beautiful landscapes&mdash;an ideal setting to build your career and enjoy life outside of work. 
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.
&nbsp;

Mechanical Technician III

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<h3>Process Engineer &ndash; External Manufacturing Drug Substance</h3>
Location: Louth, Ireland Travel Requirement: Approximately 25%
Shape the Future of Biopharmaceutical Manufacturing Are you a motivated Process Engineer looking to make an impact in the pharmaceutical industry? Join a global leader and play a pivotal role in ensuring seamless manufacturing operations through cutting-edge technology transfers and commercial production of Large Molecule Drug Substance. Be part of a dynamic team focused on innovation, continuous improvement, and world-class engineering solutions. Based in Louth, you&rsquo;ll work closely with External Partners (EPs) to optimise processes and contribute to life-saving therapies.
Key Responsibilities
<ul>
<li>
Collaborate with External Partners: Partner with External Manufacturing sites to meet business objectives, fostering a shared culture that prioritises innovation, compliance, and patient needs.
</li>
<li>
Process Improvement &amp; Manufacturing Support: Lead technical activities related to the commercial manufacturing process, including authoring change control documents, managing process improvement projects, performing statistical analysis, and investigating deviations and atypical events.
</li>
<li>
Technology Transfer: Manage and support technology transfers, including authoring and reviewing essential GMP documentation (Master Batch Records, change controls, protocols, and regulatory filings) to ensure flawless execution of tech transfer projects.
</li>
<li>
On-Site Process Support: Provide on-site coverage at External Partner facilities to support commercial production and tech transfer activities. Engage in real-time troubleshooting and process optimisation.
</li>
<li>
GMP &amp; Compliance Expertise: Ensure that processes meet Good Manufacturing Practice (GMP) standards by developing and implementing standardised work practices. Collaborate with Operations, Quality, and External Partners to maintain inspection readiness for routine and new product introduction audits.
</li>
<li>
Drive Continuous Improvement: Contribute to the adoption of best practices and innovative strategies that drive process optimisation and operational excellence. Participate in and lead improvement initiatives to enhance overall production efficiency.
</li>
</ul>
Skills &amp; Qualifications
<ul>
<li>
Education: Bachelor&rsquo;s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Science, or a related field.
</li>
<li>
Experience: At least 4 years of experience in a GMP manufacturing environment, with a strong focus on technical transfer, process optimisation, or technical operations. Drug Substance Technical Transfer experience is essential.
</li>
<li>
Communication &amp; Leadership: Excellent communication, teamwork, and project management skills. Demonstrated ability to manage projects independently and meet tight deadlines.
</li>
<li>
Technical Expertise: Hands-on experience in biologics drug substance operations (upstream and downstream), process development, statistical analysis, and deviation/change management.
</li>
<li>
Preferred Experience: Proven experience in statistics, Proactive Process Analysis, and Continuous Process Verification. Expertise in deviation management, change control, and equipment/process troubleshooting.
</li>
</ul>
Why Louth? Located in the heart of Ireland, Louth offers an exceptional quality of life, combining rich history with beautiful landscapes and a welcoming community, perfect for both career growth and life outside of work.
If you're passionate about making a difference and want to work at the forefront of biopharmaceutical innovation, this Process Engineer role in Louth could be the next step in your career! 
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.
</div>
</div>
</div>
</div>

Process Engineer 

I'm your go-to engineering recruitment consultant, specialising in the incredible world of the Medical Device Industry. If you're seeking exciting Research and Development opportunities, look no further&mdash;I've got your back! When it comes to work, I'm all about giving it my all. I'm dedicated to the candidates I work with, and their victories are just as important to me as my own.
So, whether you're itching to explore fresh opportunities in the Medical Device field or simply need some expert advice, reach out without hesitation. I'm here to guide you, support you, and ensure you find the perfect fit.
Remember, I'm more than just a consultant&mdash;I'm your reliable partner on your career journey. Let's connect!
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