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 are seeking a Project (Automation) Engineer to join our pharma client in Sligo. Job Summary The Project Engineer is responsible for safely coordinating and leading projects associated with Automation, Aseptic processing, new processing equipment, packaging, new Facility builds or modifications/extensions. The primary responsibility of the role is to ensure that the project meets its agreed goals/targets on time and on budget. The engineer reports project progress to the Project Manager to ensure the equipment/facility design and goals/targets are achieved. Responsibilities Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g. autoclaves, LAF units, moulds, extruders, packaging equipment, automated vision inspection systems, lyophilsers, isolators, containment booths, stopper processing equipment and equipment upgrades - both hardware and SCADA. Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel. Lead the Project Team or support the Project Manager in Factory Acceptance Testing program. Coordination of all equipment documentation requirements. Commissioning of equipment for validation activities. Preparation of equipment training and maintenance protocols. Report into the Project Manager on project progress and advice/support on key project outcomes Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging. Deliver Process improvement projects. Work with the relevant Business Unit team leaders to implement improvement opportunities Lead regular Equipment/Facility Project review meetings. Attend the weekly Tier Meetings. Attend monthly Department Meetings Attend monthly 1:1 mtg with supervisor. Requirements Third level qualification in an Engineering or Science or equivalent discipline/experience (Automation) Experience of working within either the medical device or bio/pharmaceutical industry would be an advantage but not necessary. 5 years+ experience. Project Management experience is preferable but not necessary Interpersonal skills required to operate in a multi-function project team set up. Ability to work within a team and on own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project. Work Type: Full-time onsite #Gertek 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 are seeking a Documentation Specialist to join our pharma client in Sligo. RESPONSIBILITIES Co-ordinate and/or execute internal and external review and approval of all Laboratory related documentation. Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP's. Be a reliable point of contact for the laboratory area for clear and precise communication of the documentation process and status of documents. To co-ordinate processing of laboratory documents into and out-of ABB Documentation systems. A key member on the laboratory readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the laboratory documents are prepared, executed and post approved in line with best practices and relevant timelines. Ensure highest Quality & Compliance standards. Track and trend relevant laboratory and business process metrics to ensure the laboratory are performing effectively and efficiently. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Support the generation of efficient, user friendly documentation including SOPs. Assist in the preparation of progress reports/presentations as required. Revise, update, and format documentation including SOPs, forms, logbooks. Write/review laboratory documentation (SOPs & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements. Will act as an SME for the laboratory function and also the wider organization in adherence to GDP guidelines. Will be flexible to take on additional tasks and responsibilities at the discretion of their manager. Applies knowledge, experience, and technical skills to understand laboratory objectives, to provide support to laboratory initiatives, to execute processes and procedures efficiently and compliantly, evaluates documents for improvement potential. Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the laboratory department. Schedules and execute tasks, with limited assistance, to support laboratory schedule timelines. Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinate referrals across the cross functional groups. Manages document review and approval to meet schedule timelines. Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan. Investigates Documentation related events in production that have quality or compliance impact. Leads or participates IIA, RCI sessions. Documents investigation outcomes. Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Comply with the company's policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements. Manage the laboratory Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting. REQUIREMENTS Bachelor's Degree or equivalent preferential, preferably in a Science or related field Experience Level = 1+ Years Experience in a regulated laboratory setting. Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred. Expertise with Microsoft Word with a solid understanding of the review and formatting tools is required. Expertise with Outlook, Visio, Excel, PowerPoint is required. Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required. Experience with the use of electronic systems to manage, edit and control documents is preferred. A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards Previous experience in a fast-paced and deadline driven environment is required. Job Type: Full-time #Gertek 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 are seeking a QC Analytical Analyst to join our pharma client in Sligo. RESPONSIBILITIES Ensuring Analytical Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements. Understanding Regulations and business processes required to maintain Laboratory Data Integrity. Ensuring timely completion of all laboratory analysis assigned to shift. Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance. Improving the overall efficiency and velocity within the assigned team. Identifying and implementing improvements in analytical practices using 'Zero, Believe it, Achieve it' Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements. Identifying weaknesses in laboratory performance and working with the laboratory management to rectify. Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through the quality system. Ensuring 5S excellence is maintained across the Laboratory. Instilling a quality culture of Zero, Believe it, Achieve it amongst the laboratory team Ensuring that all laboratory test equipment is utilised and maintained correctly. Maintaining up-to-date, complete and precise records of all tests performed. Investigates Documentation related events in production that have quality or compliance impact. Leads or participates IIA, RCI sessions. Documents investigation outcomes. Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Comply with the company's policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements. REQUIREMENTS Bachelor's Degree or equivalent preferential, preferably in a Science or related field Experience Level = 1+ Years Experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines Proven track record in an analytical role. Proficient in using analytical equipment in a QC lab as well as troubleshooting. Knowledgeable in instrumentation such as UHPLC, SoloVPE, TOC, and Identification techniques. Experience in industry is essential. Job Type: Full-time onsite #Gertek 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 & 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. #Gertek 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 Work with 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? 2-5 years project engineering experience, ideally in life sciences Bachelor of Science/Engineering in Mechanical /Process Engineering or equivalent discipline. Excellent problem-solving and critical thinking abilities. #Gertek 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. 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 Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. QA support for validation investigations and implementation of corrective actions. Creation/Review/Approval of various validation and qualification documents Management of validation, exception event, and change control processes. Documenting all activities in line with cGMP requirements. 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. Communicating with peers and management regarding activities in the area, including elevation of events or concerns Requirements 2+ years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area. 2+ years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry Strong communication (written and oral), presentation and troubleshooting skill required Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. #Gertek 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 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 - MES Engineer - Westport Purpose Maintain the MES (POMSnet) environment; to author & maintain recipes & worksheets for Westport site. Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring. Responsibilities Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic Design, create, write and execute, test and validation protocols, risk assessments, and system documentation. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa. Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access. Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified. Liaise with the Global MES on Westport required system improvements. Provide support to other MES system users as required to ensure business continuity. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration. Keep other recipe authors up to date on MES changes Documentation of all activities in line with cGMP requirements. Cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Adheres to and supports all EHS standards, procedures and policies. Requirements Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience. A minimum of 2 years authoring experience preferably using POMSnet. Be familiar with MES application and configuration rules and requirements including interfacing (preferably POMSnet). Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry. A good knowledge of IT systems is required for this role. SAP knowledge/experience in MM, PP and IM modules an advantage. Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times. #Gertek 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 are seeking a CQV / C&Q / Commissioning and Qualification Engineer Key Responsibilities The CQV Engineer will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment. This role will support both new and legacy equipment. This role is an individual contributor role whereby the individual must be a self-starter with significant professional experience design, commissioning, qualification and continuous improvement of pharmaceutical facilities, utilities and equipment. Education A minimum of an Honours degree in an Engineering or Science discipline Experience Proven experience in authoring, review and execution of CQV activities on a variety of Facility, Utility and Process Equipment is essential. Experience with clean utilities and aseptic processing facilities would be an advantage. Experience in Computer Systems Validation is desirable. Experience in temperature mapping of temperature control devices and sterilization cycles is desirable. Responsibilities Prepare, execute and report on CQV activities for assigned systems to include C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ and where applicable PQ activities. Prepare, review and approve project documentation, ensuring technical accuracy and adherence to cGMP. Support design reviews and system risk assessments with multiple stakeholders. Confirm all vendor documentation executions are compliant with GxP practices and the executed documentation is acceptable to support CQV. Complete field verifications during static and dynamic (functional) tests. Participate in startup activities of energized equipment when necessary. Interaction with vendors for project planning. Perform system P&ID walkdown with construction prior to handover. Categorization of punch list items & tracking to completion. Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise. Confirm the site installation is as per approved design specification and meet system IQ requirements. Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation). Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents. Manage project change and CQV discrepancies through close interaction with System User and Quality Assurance. Support the handover of contractor and vendor systems to the user. Ensuring that all vendors and sub-contractors assigned to the specific tasks are trained and have experience to carry out tasks. Liaise with the various stakeholders on the Project team and the overall project to ensure clear communication between all parties. Participation in and execute design reviews (DQ), when required. Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation. Manage the site attendance for the vendors, contractors and specialist contractors. Liaising with Construction management team to ensure completion of mechanical completion packs, review of all contractors packs for traceability, review of all supporting vendor documents in timely manner to support execution. Where necessary attendance at FAT's at Vendor Sites anticipated to be in mainland Europe. CQV / C&Q / Commissioning and Qualification Engineer Job Type: Full-time #Gertek 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. Overview: This role focuses on leading the development and implementation of a comprehensive electrical maintenance program for a large-scale facility. The successful candidate will possess expert knowledge of electrical systems and industry best practices, ensuring the site's electrical infrastructure is maintained to the highest standards of safety and compliance. Responsibilities: Assessment & Documentation: Conduct a thorough evaluation of all electrical systems ( MV, LV) and infrastructure within the facility. Create detailed architectural drawings, documenting the electrical hierarchy and life support systems. Develop and maintain comprehensive electrical system documentation, including standard operating procedures (SOPs), manuals, and handover packs. Program Development & Implementation: Develop and implement a robust preventative and predictive maintenance program for all electrical systems. Establish and manage a maintenance program for electrical PPE and test equipment. Ensure compliance with all relevant European Electrical standards and regulations. CMMS Management: Update and maintain the site's computerized maintenance management system (CMMS) with accurate information on all electrical assets. Develop and implement preventative maintenance job plans within the CMMS. Continuous Improvement: Stay abreast of the latest technologies and updates to electrical standards. Proactively recommend and pursue electrical infrastructure improvements. Provide regular condition reports for critical electrical systems, ensuring appropriate maintenance programs are in place. Project Management & Support: Lead and coordinate site-wide electrical power down/up events, ensuring minimal disruption to operations. Act as the point of contact for all electrical project works, including review of handover packs. Maintain and update site electrical drawings, arc flash studies, and ATEX registers. Safety & Compliance: Ensure all electrical systems are maintained and upgraded in compliance with safety regulations. Maintain accurate arc flash panel signage and PPE requirements. Develop and maintain a site ATEX program, including PMs, reports, and PPE management. Represent the electrical program during external inspections (e.g., FM Global). Qualifications: Bachelor's degree in Electrical or Mechatronic Engineering OR National Craft Certificate in Electrical Engineering Extensive experience in the electrical field #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
