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. The Role As a Utilities Engineer, you will be responsible for the reliability, maintenance, and continuous improvement of all critical site utilities and facilities. You'll manage key projects, oversee budgets, and ensure our site operates efficiently and in full compliance with cGMP standards. What You'll Do (Key Responsibilities) Utilities & Facilities Management: Oversee the maintenance and performance of critical utilities (Boilers, Chillers, Compressed Air, Water Systems). Manage the site's Building Management System (BMS) and Environmental Management Systems (EMS). Drive our Maintenance Excellence Program to improve operational efficiency and uptime. Project Management & Continuous Improvement: Lead and execute utility and facility upgrade projects from concept to completion. Develop and prepare Capital Expenditure (CAPEX) requests for new plant and equipment. Identify and implement process improvements to enhance efficiency and reduce costs. Compliance, Safety & Quality: Ensure all engineering activities meet cGMP, safety (EHS), and regulatory standards. Lead engineering compliance for internal and external audits. Prepare and implement Corrective and Preventive Action (CAPA) plans. Budget & Contractor Management: Manage departmental budgets and report on key performance metrics. Supervise and manage external contractors, negotiating costs and ensuring high-quality service delivery. What You'll Need Essential: Level 8 Degree in Engineering (Mechanical, Electrical, Chemical, or related discipline). 5+ years of experience in a Facility or Utilities Engineering role. Strong background working in a cGMP environment (e.g., Pharmaceutical, Medical Device). Desirable Skills: Hands-on experience with systems like: Chilled Water, Boilers, LPHW, Compressed Air, and Water Distribution. Proven experience managing engineering projects, budgets, and contractors. Knowledge of Building Management Systems (BMS), safety regulations, and compliance audits. 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 with our technically Role Title: Operations Accountant Purpose: Responsible for all of the Financial affairs of the Plant. Primary objective is to plan, control, administer, interpret and report the financial affairs, both to management at local level and division. Preparation of Monthly Financial and Management Accounts to strict deadlines. Preparation of Annual Plan and Updates and revisions to same. Control Capital Expenditure. Forecast and reporting on project expenditure. Ensure all policies and procedures are adhered to including Sarbanes - Oxley compliance. Provide Support to Manufacturing Facility. Responsibilities: Ensure that monthly accounts are completed and reviewed within a pre-determined schedule. Update and evaluation of Project Management System. Preparation of all plans/updates and LBE's for review by Plant Finance Manager and Site Director. Produce monthly balance sheet reconciliations. Review and Maintenance of all Requests for Capital Expenditure. Evaluate and record all cost improvement programs. Ensure monthly accounts comply with all policies and procedures including Sarbanes - Oxley requirements. Provide Support to the Manufacturing Facility, participation in weekly meetings, and awareness of safety. Project Evaluation - involves the continuous update and review of projects so as to assist the Site Director and Plant Controller in accurate decision-making. Variance Analysis - Monthly Management accounts must be reviewed, to identify any deviations from Plan or Update thereby enabling corrective action to be taken if necessary. Technical Activities - Provide advice and information to all employees on accounting issues. Working with the Plant to ensure plans, updates and LBE's are achieved. Project Management - ensure projects are running in line with expectations. Adheres to and supports all EHS standards, procedures and policies. Qualifications: Qualified Accountant - ACCA, ACA or ACMA Job/Technical Skills A minimum of 3 years' experience in a financial/accounting position. Work location - Onsite 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 with our technically Product Quality Inspector Dept: Operations Reports to: Manufacturing Team Lead Responsibilities ? To work as a team member to support biologics operation in pharma operations in line with all safety, regulatory and organizational requirements. ? Visual Inspection Technician will be assigned to the daily production operations . ? Documentation of all activities in line with cGMP requirements. ? Perform final product visual inspection. ? Perform product intermediary packaging, as applicable. ? Perform in process testing methods. ? Monitor Process Alarms. ? Material receipt from warehouse, verifying all pertinent documentation. ? Transfer of final material to warehouse inventory. ? Ensure all manufacturing documentation is completed on a timely manner without errors, following cGMP's. ? Diagnose and resolve events or exceptions of VI process. ? Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation. ? Keep detailed records, manual or electronic, of the operations carried out during the work shift. ? Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment. ? Adhering to all relevant policies relating to Quality & Safety. ? Ensure successful external inspections, and Division and Corporate audits. ? Active participant in the development of batch records and electronic batch records for the site. ? Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures. Requirements ? Leaving Certificate and 1 years' experience in GMP manufacturing ? 1 year plus of Knowledge of GMP and regulatory requirements relating to the pharma/biologics industry. ? 1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable. ? Essential: Requires annual visual test certification for colour blindness and 20/20 vision. ? A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable. ? Experience in handling of dangerous chemicals is highly desirable. ? Good I.T. skills are required. ? Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI. Work location - Onsite Job type - Full-time Shifts - 16/5 shift @ Extra (23:00 - 07:00). 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.
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.
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 projectsEducation: 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.
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.
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. Purpose: The Project Engineer is responsible for safely coordinating and leading projects associated with Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility / utilities modifications to incorporate same. The primary responsibility of the role is to ensure that Projects meet their agreed goals/targets on time and on budget. Responsibilities Led and manage multiple aseptic cleanroom projects from conception to completion, adhering to strict regulatory and quality standards. Collaborate closely with cross-functional teams, including architects, facility engineers, and quality assurance personnel, to ensure successful execution of projects. Develop detailed project plans, timelines, and budgets, ensuring effective utilization of resources and timely delivery of projects. Oversee the procurement of equipment, materials, and services, ensuring compliance with project specifications. Monitor project progress, identified potential issues, and implemented corrective actions to ensure projects stayed on track. Coordinate with external contractors and vendors, ensuring adherence to project requirements and specifications. Conduct regular inspections and audits to ensure compliance with cleanroom standards and regulatory guidelines. Prepare comprehensive project documentation, including reports, progress updates, and final project summaries. Led equipment FAT/SAT on process equipment and coordinate the engineering aspects of qualification. Become the engineering SME for the project and process. So, what education & experience do you need for this role? 5+ year's experience in working within the pharmaceutical manufacturing, medical device or similar industry Bachelor of Science/Engineering in Mechanical /Process Engineering or equivalent discipline. Excellent problem-solving and critical thinking abilities. 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 with our technically Responsibilities: To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements. Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival. Owning and preparing, preventative and predictive maintenance for new pharma equipment being installed and approval of these procedures on Maximo. Completion and documentation of PM's and pDM's on manufacturing equipment into Maximo. Owning and ensuring that commissioning spare parts are received and cataloged in Maximo. Owning and ensuring that critical spare parts are identified and once received, catalogued in Maximo. Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment. Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements. Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID's. Ensuring proactive high performance of day-to-day preventative and demand maintenance activity to maintain manufacturing and utility equipment. Liasing with operations, quality and technical operations to ensure equipment and process performance is maximized. To maintain records and documentation on relevant Engineering Procedures and preventative/ demand maintenance. To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting and installing/commissioning equipment. Completion of instrument calibration as per schedule. Take ownership of the site's Predictive Maintenance program, through managing and developing the outsourced condition monitoring contracts, implementing recommendations, and tracking to closure. Implementation of equipment/process upgrade in an environment of continuous improvement. Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements. Adhering to all relevant policies relating to Quality & Safety. Ensure successful external inspections, and Division and Corporate audits. Supervision of external contractors. Requirements: Relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred). Technical/Business Knowledge Minimum of 3 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required. Proven problem-solving ability on complex equipment. We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Maintenance Technician seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. Job Type: Full-time Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.