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 Project Management & Technical Services is an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are hiring for experienced equipment project managers to join the team. Equipment Project Engineer - Pharmaceutical Manufacturing Summary: Leads the planning, execution, and delivery of equipment-related projects within pharmaceutical manufacturing, ensuring compliance with GMP, budget, and timelines. Responsibilities: Manage all phases of equipment projects, from concept to commissioning. Develop project plans, budgets, and schedules. Coordinate with engineering, operations, and quality teams. Oversee vendor selection, procurement, and installation. Ensure equipment qualification (IQ/OQ/PQ) and validation. Manage project documentation and reporting. Mitigate project risks and resolve issues. Ensure compliance with GMP and safety regulations. Qualifications: Bachelor's degree in Engineering or related field. Project Management Professional (PMP) certification preferred. Experience managing equipment projects in pharmaceutical manufacturing. Strong knowledge of GMP and regulatory requirements. Proven ability to manage budgets, schedules, and resources. Excellent communication and leadership skills. Experience: Equipment qualification (IQ/OQ/PQ): 4 years (required) Project Management / Engineering: 2 years (required) Job Type: Full-time Work authorisation: Ireland (required) Work Location: In person 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: Degreein 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.
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 have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: Title: Utilities Project Engineer Major Duties and Responsibilities Project Management: Plan, execute, and manage utility system projects, including black and clean utilities, ensuring timelines, budgets, and quality standards are met. Develop project charters, schedules, and risk management strategies. Coordinate with internal and external stakeholders to ensure seamless project execution. Utilities Oversight: Manage the installation, commissioning, and qualification of utility systems such as HVAC, water systems (WFI, purified water), clean steam, compressed air, and boilers. Ensure integration with manufacturing systems and overall facility operations. Compliance and Standards: Ensure all utility systems comply with GMP, FDA, and EHS regulations. Collaborate with QA and validation teams to meet documentation and qualification requirements. Team Collaboration: Liaise with cross-functional teams including engineering, operations, quality, and maintenance. Supervise contractors and vendors during project phases. Performance Monitoring: Track project KPIs and provide regular updates to stakeholders. Address and resolve issues related to project scope, schedule, and budget deviations. Documentation and Reporting: Prepare technical documentation, including URS, FRS, FAT/SAT protocols, and validation reports. Ensure proper turnover of utility systems, including as-built drawings and O&M manuals. Key Qualifications: Education: Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, or related field). Advanced degree or PMP certification is a plus. Experience: Minimum 5+ years of experience in utilities management in a pharmaceutical, biotech, or GMP-regulated environment. Proven track record of managing projects involving black and clean utility systems. Technical Skills: Strong knowledge of utility systems: HVAC, clean steam, water systems (WFI, purified water), compressed air, and boilers. Familiarity with P&IDs, equipment design, and regulatory standards (GMP, FDA, ISO). Proficient in project management tools (e.g., MS Project, Primavera) and CAD software. Soft Skills: Strong leadership and communication skills. Excellent problem-solving and decision-making abilities. Ability to manage multiple priorities in a fast-paced environment. Why Join Us? Opportunity to work on cutting-edge pharmaceutical projects. Collaborative and supportive work environment. Competitive compensation and benefits package. If you are a self-driven and detail-oriented Utilities Project Manager 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.
GerTEK Project Management & Technical Services is seeking to recruit an experienced Project Manager to join our team in Sligo. Sligo Based Capital Projects Manager Role: Lead and manage capital projects within a life science manufacturing environment, ensuring on-time, within-budget, and compliant delivery of new equipment, facility upgrades, and infrastructure improvements. Responsibilities: Manage the full project lifecycle from initiation to close-out, including scope definition, budget development, scheduling, resource allocation, and risk management. Oversee the design, procurement, installation, and validation of capital equipment and facility modifications. Ensure projects adhere to relevant regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards. Collaborate effectively with cross-functional teams including Engineering, Manufacturing, Quality, and Validation. Manage external vendors and contractors. Track project progress, report on key metrics, and proactively address potential issues. Develop and maintain project documentation. Qualifications: Bachelor's degree in Engineering or a related technical field. Proven experience (5+ years) managing capital projects within the medical device or a similarly regulated industry. Strong understanding of GMP, regulatory compliance, and validation processes. Excellent project management, communication, and stakeholder management skills. Experience with equipment procurement, installation, and commissioning. Familiarity with cost control and budget management. To start the process click the Continue to Application or Login/Register to apply button below.
Location - Westport, Mayo Role title: Operational Technology Systems Engineer (Pharma) Join our team and help bring innovation in the lifesciences sector. We're seeking an OT Systems Engineer to help with regulatory compliance, data integrity, and process automation. What You'll Do: OT System SCADA Engineer role supports lifecycle management of Operational TechnologySystems & applications across the Westport Manufacturing Site. The OT Systems Engineer willbe expected to support all aspects of the Production OT systems and provide development andinstallation support for new hardware and software solutions. Key responsibilities: Responsibilities: Support of Operating System platforms and OT software applications Provision of technical support and direction to Manufacturing Operations, Validation Engineers, and IT support staff as part of Manufacturing project support and project execution including transfer to production. Provision of support for root cause problem solving and the implementation of CAPA's. Assist with design and build of secure, robust, highly available fit-for-purpose and future proofed application environments. Follow the OT lifecycle management processes that meet or exceed regulatory expectation in respect of data integrity: data backup regimes and system recovery testing. Creation of technical documents required to complete SDLC document set, and knowledge articles required by Tier 2 and Tier 3 support teams. Support any safety or quality initiatives that require Operational Technology support. Support cost savings initiatives onsite and within the Automation team Participate in departmental and customer project status update meetings. Support operational excellence activities to continuously improve our processes and eliminate waste. Qualifications: Bachelor's degree in information technology, Computer Engineering, or related discipline / equivalent experience. 3 to 5 years' experience delivering IT services preferably within the Pharmaceutical and/or medical device industry. System Admin Windows 10 and Windows Server Expertise in the following technologies: SCADA, Historian, Thin Client Manager, Active Directory and group policy permissions, XML/XSL, SQL DBA and the development of SQL Queries, Stored Procedures and Reporting. Extensive experience delivering automation projects (PLC and SCADA). Aseptic processing and or packaging equipment experience. Experience with delivering complex projects, ideally related to manufacturing modernization / manufacturing system upgrades to support business critical process equipment. Employment type: Full-time Work location: Onsite 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 have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: QA Compliance Specialist Key Responsibilities: Ensure adherence to standards for both marketed and investigational drug products leaving the site. Guarantee compliance of products and aseptic processes with end-user, regulatory, and company requirements. Provide quality and compliance oversight for Operations, ensuring manufacturing aligns with site policies. Conduct quality oversight during aseptic processing, including observing aseptic interventions. Lead/assist in investigations related to non-compliance in product or manufacturing processes. Review and audit completed Batch Records and Manufacturing Logs. Complete quality reviews of operations documentation (SOPs, JSTMs, Risk Assessments). Perform Line Clearance activities and Incoming Raw Material checks. Provide Stability Program Support, including sample pulls and weekly checks. Maintain finished product status and administer Quality Logs (e.g., QA Hold, Sample Request). Lead daily walkarounds of manufacturing areas. Drive continuous improvements and streamline processes for compliance. Offer support as needed. Education & Key Requirements Third-level degree in a science, quality, or engineering discipline. Minimum three years' experience in quality/operations in a regulated GMP environment. Aseptic processing experience in quality or operations is highly desirable. Strong knowledge of regulatory requirements. High attention to detail and mental concentration for accuracy and compliance. Total commitment to quality and maintaining high standards. Demonstrates integrity, strong work ethic, and supports compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated QA Compliance 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.
GerTEK is an engineering consultancy company. 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 are hiring for an experienced pharmaceutical engineers to join our projects in Sligo. You'll play a key role in maximizing equipment availability and optimizing plant efficiencies through expert project management and continuous improvement initiatives. Responsibilities: Manage capital engineering projects (up to €5M) from conception to completion. Maximize equipment uptime and optimize process performance. Lead continuous improvement and process safety initiatives. Provide expert technical support and troubleshooting across site operations. Oversee equipment commissioning and validation. Collaborate with internal and external teams, including contractors, to deliver projects. Requirements: Degree in Mechanical, Chemical, or Process or similar Engineering Experience in API, OSD, or Bio Pharmaceutical manufacturing Proven track record of delivering projects. Job Type: Full-time 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. We're looking for aManager, Global Labeling Operationsto 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 To start the process click the Continue to Application or Login/Register to apply button below.
