Sligo Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. PROJECT ENGINEER Responsibilities: To provide Engineering services to the plant, in order to maximise the availability of all Site Process Equipment and Utilities. To manage capital engineering projects within site following the Project Lifecycle approach (typical project value range: anything up to €5 million). To support the engineering teams in controlling uptime of process equipment and optimizing efficiencies both in equipment and process performance. To support the Engineering team with the emphasis on continual operational improvements. To provide process engineering support and technical trouble shooting within the site. To improve the operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives. To manage the execution of projects within the engineering group including specific Process Safety Projects. To support the provision of process safety initiatives to the site. To liaise with Production to ensure equipment performance is maximized. To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment. To provide engineering support and technical trouble shooting to all site operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives. Leadership of process equipment commissioning and validation activities. Identification and project management of continuous improvement projects. Work closely with all site functions and other departments to deliver these continuous improvement projects. Preparation of feasibility studies and budget management for all assigned projects. Management and negotiation of external contracts and contractors. Support all major site initiatives and sites core goals. Requirements Degree in a relevant Engineering Discipline (Mechanical/Chemical/Process) Experience in API Manufacturing / OSD Manufacturing / BioPharm Proven track record in delivering Capital Projects - new equipment, utilities, facilities, etc. Good knowledge of change control and C&Q processes/execution. To start the process click the Continue to Application or Login/Register to apply button below.
Sligo Based Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a CQV Engineer for our Sligo based client. CQV Engineer Key Responsibilities: Commissioning & Qualification of new aseptic manufacturing equipment Writing and execution of qualification documentations such as: FAT, SAT, IOQ, PQ protocols Provide Support for the development of URS and Functional Specification associated with asepctic processing Provide technical assistance during investigations or process/equipment Ensures on-time execution of the schedule and reports Ensures Periodic Review plans are completed per site & regulatory requirements Collaborates with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements. Ensures validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.). Provide change control assessments which could impact the validated state of process equipment. Leading Risk assessments, root cause analysis and investigations as applicable. Own departmental SOPs and ensure they follow corporate standards and applicable regulations Equipment: Single Use Equipment, Mobile Equipment - SUM/TCU/Utility Panels/Reactor Facility Qualification OR Fine Line (Vial / Syringe ) / Lyo /Capper / External Vial Washer Qualifications Previous experience in execution of asepctic equipment/qualification/asepctic processing Advanced knowledge of FAT, SAT, IOQ Risk - based verification Previous experience on Kneat/online validation package We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated CQV Specialist seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below.
Biologics Process Equipment Engineer We're seeking a Biologics Process Equipment Engineer to join our Engineering team. You'll be a Subject Matter Expert for vial filling and isolator equipment, supporting our pharmaceutical operations. What you'll do: Act as the SME for vial filling and isolator equipment, from design to handover. Lead FAT and SAT activities to ensure equipment meets technical requirements. Develop and execute commissioning plans and review validation protocols. Troubleshoot equipment malfunctions and support continuous improvement initiatives. Collaborate with internal and external teams to optimize equipment and process performance. What you'll bring: Degree in Engineering, Science, or a technical discipline. 5+ years of combined experience in Process, Equipment, or Manufacturing Engineering within a pharmaceutical or healthcare organization. 3+ years in a manufacturing environment (biotechnology, pharmaceutical, or healthcare). Experience with biotechnological or parenteral drug manufacturing, solutions preparation, and sterilization is a plus. Familiarity with new product introductions to pharmaceutical facilities is desirable. To start the process click the Continue to Application or Login/Register to apply button below.
About GerTEK: GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & have multiple projects that we support. We're looking for a hands-on and proactive Facilities Engineer to join our team! In this role, you'll be the go-to person for keeping our building's systems and infrastructure running smoothly. You'll ensure our facility is safe, efficient, and well-maintained, playing a vital part in our company's daily success. If you're a problem-solver with a strong technical background, we'd love to meet you. Key Responsibilities System Maintenance: Oversee the operation and maintenance of key building systems, including HVAC, electrical distribution, plumbing, and life safety systems. Preventative Maintenance: Develop and manage a preventative maintenance (PM) schedule to minimise downtime and ensure equipment reliability. Project Management: Manage small to medium-sized facilities projects, from system upgrades and equipment installations to office reconfigurations. Vendor Coordination: Liaise with and manage external contractors and service providers for specialised maintenance and repair work. Compliance & Safety: Ensure the facility complies with all health, safety (EHS), and environmental regulations. Qualifications & Skills A degree (Level 7 or 8) in Mechanical, Electrical, or Facilities Engineering, or a related technical field. 3+ years of experience in a facilities engineering or maintenance role, preferably in a manufacturing, corporate, or industrial environment. Strong technical knowledge of mechanical and electrical (M&E) systems. Experience with building management systems (BMS) is a plus. Excellent troubleshooting skills and a proactive approach to problem-solving. Strong organisational and communication skills. To start the process click the Continue to Application or Login/Register to apply button below.
Capital Project Manager GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Major Duties and Responsibilities Project Management: Is a Project Management Subject Matter Expert. Independently Scope, Plan, Execute/Monitor and Close complex long duration projects. Uses Project Management tools and methodologies e.g. PMBOK, PRINCE 2, to deliver projects consistently. Strategic and Results Orientation: Demonstrates fiscal responsibility through project scoping and execution and defines actionable recommendations. Translates top-level project goals to specific project tasks, milestones and deliverables. Financial Control: Ensure financial control of the project with monthly updates on cashflow for the duration of the project. Communication: Develops communication strategy for projects to ensure Project teams, Project Sponsor, key stakeholders and site/external management understand project plans, risks and progress. Stakeholder Management: Garners support from and manages key stakeholders to enable successful project outcome including resource allocation negotiation. Establishes and cultivates an extensive network of support to facilitate completion of assignments. Risk Management: Performs project risk management from project outset and develops appropriate contingency plans. Effectively balances compliance risk and business risk when developing project plans. Contingency Planning: Develops contingency plans to mitigate impact of project issues that may impact on project delivery. Scope Management: Develops and agrees Scope with Project Sponsor. Actively manages project scope to prevent scope creep. Evaluates impact of Scope changes and adjusts project plans as required. Quality Management: Ensure that assigned projects are performed to meet the quality requirements of customers, internal quality systems, internal & external auditors and other external agencies. Knowledge Sharing: Shares project management knowledge and assists/mentors more junior project managers in project management processes and techniques EHS: Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimization are adhered to and improvements made where possible. Leadership Activities Provides leadership and direction to project teams to meet established timelines and site goals and objectives. Independently manages external facing complex projects Education: Third Level Qualification in a relevant discipline Experience/ Background Experience in areas such as Technical Support, Supply Chain, Operations, Quality, Engineering and/or Business Excellence. History of successful project delivery in at least one area of the business. Working within a highly regulated manufacturing environment with project management skills as this provides a good foundation for this job function. Strong planning and organizational skills coupled with necessary knowledge of diagnostics technical, manufacturing and/or supply activities. Projects Examples: Heat pump installation New loading Bay in warehouse A warehouse sprinkler upgrade A palletizing robot on a manufacturing line To start the process click the Continue to Application or Login/Register to apply button below.
Job description: GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & have multiple projects that we support, Engineering Technician (Assembly) We're looking for an Engineering Technician (Assembly) to join our team, supporting Moulding/Tooling and Assembly operations. You'll be a key player in ensuring smooth production, optimizing processes, and driving continuous improvement. What you'll do: Support Moulding, Tooling, and Assembly operations, ensuring safety and regulatory compliance. Be a Subject Matter Expert in routine equipment and process maintenance. Troubleshoot and resolve technical issues for injection molding machines, tooling, and automated/semi-automated assembly equipment. Fabricate mechanical and electrical parts for repairs and upgrades. Provide technical support to operations, ensuring production targets are met. Participate in project teams and continuous improvement initiatives. Execute routine manufacturing documentation, commissioning, and validation protocols. Maintain cGMP standards in production areas and utilize the Maximo management system. What you'll bring: Leaving Cert, Senior Level Trade Certificate, or FETAC Level 6 in a technical field (or commitment to obtain). 3+ years experience in a high-precision manufacturing industry. 2+ years experience in a regulated manufacturing environment. Proficiency in Mold Tooling, Electrical, and Automation. Strong computer skills, including operating computer-interfaced equipment and ERP systems. Proven problem-solving abilities on complex equipment. Job Type: Full-time Application question(s): Do you have experience in a Medical Device Environment? Have you got experience in new automation introduction i.e. NPI? Do you have experience in Medical Device Automation Validation? To start the process click the Continue to Application or Login/Register to apply button below.
GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team. The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards. Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. To start the process click the Continue to Application or Login/Register to apply button below.
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Job Title: Senior Electrical Maintenance Engineer Job Summary We're looking for an experienced Senior Electrical Engineer to join our team. You'll be a key technical expert, playing a vital role in ensuring the reliability, safety, and compliance of our electrical systems within a cGMP manufacturing environment. In this role, you will manage significant projects, support site-wide initiatives, and provide high-level technical support for our advanced operations, helping to drive the success of the engineering department. Key Responsibilities Technical Support & Compliance: Serve as a senior technical resource for the site's electrical infrastructure. Support the design, maintenance, and troubleshooting of systems (MV/LV, UPS, VFDs) to ensure they meet all regulatory standards like ETCI and ATEX. Project Management: Manage and execute assigned electrical capital and improvement projects, from scope development through to commissioning and handover. You'll be responsible for project timelines, budgets, and contractor coordination. Safety & Documentation: Champion site safety, particularly for high-risk electrical work, and contribute to critical safety programs like Arc Flash analysis. Assist in maintaining accurate technical documentation, including electrical drawings and SOPs. Continuous Improvement: Proactively identify opportunities for improvement in electrical systems and energy efficiency. You will lead or participate in cross-functional teams to implement these enhancements and support the site's operational excellence goals. Qualifications Bachelor's Degree in Electrical or Mechatronic Engineering (OR) National Craft Certificate in Electrical Engineering Job/Technical Skills Extensive experience as an Electrician/Engineer. To start the process click the Continue to Application or Login/Register to apply button below.
Position Summary The Maintenance Controls professional will be responsible for the troubleshooting, maintenance, and continuous improvement of automated control systems within our production environment. This role requires a candidate who combines a strong, hands-on electrical background with deep expertise in modern automation and control systems. You will act as a key technical resource, diagnosing complex faults, implementing robust solutions, and driving initiatives to increase machine uptime and overall equipment effectiveness (OEE). Key Responsibilities Perform advanced, systematic troubleshooting on high-speed automated production equipment, identifying and resolving electrical, instrumentation, and control system issues. Conduct root cause analysis of equipment breakdowns, implementing effective corrective and preventative actions (CAPAs) to prevent recurrence. Utilise diagnostic software to analyse PLC and HMI code, identifying logic-based faults within complex manufacturing systems. Identify opportunities for system improvements; support the design, installation, and commissioning of control system upgrades to enhance machine performance, reliability, and safety. Provide expert technical support for a variety of complex systems, including multi-axis robotics, servo drive systems, vision inspection systems, and other high-speed manufacturing equipment. Develop and execute preventive and predictive maintenance schedules for all control systems, instrumentation, and critical electrical components. Ensure all automation and control systems comply with company and industry safety standards, performing safety verifications and validations after interventions. Maintain accurate and up-to-date technical documentation, including electrical schematics, software backups, and maintenance records, in line with GMP standards. Collaborate effectively with production, quality, and project engineering teams on maintenance activities and improvement projects. Candidate Profile: Essential Requirements Hands-on experience in an automation, controls, or technical maintenance role. Experience in a regulated manufacturing environment (e.g., Medical Device, Pharmaceutical etc) Demonstrable proficiency with major PLC platforms A proactive and analytical mindset geared towards continuous improvement and effective problem-solving. To start the process click the Continue to Application or Login/Register to apply button below.
Job description: GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. We're looking for a Manager, Global Labeling Operations to lead strategic labeling project management and ensure compliance and supply chain efficiency for our products worldwide. Responsibilities: Lead global labeling projects, from strategic planning to execution, ensuring accuracy and regulatory compliance. Drive packaging and artwork strategy across the product lifecycle. Manage label changes for new launches, site transfers, and country-specific needs. Collaborate with cross-functional teams (Manufacturing, Regulatory, Supply Chain, etc.) to achieve "Perfect Label" standards. Own and optimize labeling business processes, including performance metric reporting. Represent Global Label Management in early development and launch activities. Qualifications: Bachelor's Degree in Science, Engineering, Business, or Supply Chain. 5+ years' experience in Operations, Regulatory, or Quality within a pharmaceutical/device environment. Proficiency in English; strong communication, negotiation, and problem-solving skills. Demonstrated leadership in driving cross-functional collaboration in complex matrix environments. Understanding of regulatory, quality, and supply chain aspects of labeling. Job Type: Full-time Experience: Pharmaceutical or Medical Device: 4 years (required) Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.
