GerTEK, an engineering consultancy, is seeking an NPI Compliance Specialist for a Sligo‑based client. Key Responsibilities Ensure new products transferred to site are manufactured following applicable regulatory requirements and policies. Maintain the effectiveness of integration of new products into the NPI quality system. Support new product transfers from development through to commercialization, liaising with local and external cross‑functional teams to provide direction on quality concerns and ensure appropriate mitigation. Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage. Support review and approval of NPI related Analytical Test Method Transfers and/or validation. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities, identify potential quality issues, understand the quality compliance, and provide input on quality concerns. Coordinate site review of new product related material specification documents including in process, BDS, drug product, raw material, and excipient specifications. Support review and approval of new product related analytical Test Method Transfers and/or validation. Support management of new product related exception documentation, including generation of corrective and preventative action to prevent reoccurrence. Generate product transfer documentation to attest completion of product transfer deliverables in advance of applicable product transfer stage‑gate review. Serve as subject‑matter expert for new products and technology transfers, interfacing with internal auditors and outside regulatory agencies/auditors. Requirements Third‑level qualification in a science, quality, or relevant discipline. Minimum of three years experience in a quality role supporting new product introductions. Strong knowledge of regulatory requirements. Background in regulatory, quality and new product introduction. Desirable: two years experience in an aseptic processing environment. #J-18808-Ljbffr
An engineering consultancy is seeking an NPI Compliance Specialist for a Sligo-based client. This role focuses on ensuring that new products are manufactured in compliance with regulatory requirements and supporting the transfer process from development to commercialization. Candidates should possess a third-level qualification in a science or relevant discipline, along with three years of experience in a quality role. Strong knowledge of regulatory standards is crucial for success in this position. #J-18808-Ljbffr
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: We are seeking an NPI Compliance Specialist for our Sligo based client. Key Responsibilities: To ensure new products transferred to site are manufactured following applicable regulatory requirements and policies. Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system. NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk. Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage. Support review and approval of NPI related Analytical Test Method Transfers and/or validation. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns. Coordination of site review of new product related material specification documents including but not limited to in process, BDS , Drug Product , raw material and excipient specifications. Support review and approval of new product related analytical Test Method Transfers and/or validation. Support the management of new product related exception documentation, including the generation of corrective and preventative action to prevent reoccurrence. Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review. Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers. Requirements: A third level qualification in a science, quality or relevant discipline. A minimum of three years experience in a quality role supporting new product introductions. Strong knowledge of regulatory requirements is required Regulatory, quality and New product introduction background . Desirable: 2 Years' experience gained within an aseptic processing environment #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.
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. This is a 4 day work week role, Tues - Fri night shifts only Join our engineering team to ensure peak operational performance and safety across our manufacturing and plant equipment. This role balances hands-on technical troubleshooting with high-level project coordination and continuous improvement. Core Responsibilities Maintenance & Reliability: Execute day-to-day preventative and demand maintenance for manufacturing equipment and plant utilities (HVAC, water systems, etc.). Troubleshooting: Perform advanced mechanical and electrical troubleshooting to minimize downtime and hit production goals. Project Engineering: Coordinate equipment installations, commissioning, and process upgrades. Prepare Capital Expenditure (CapEx) requests. Validation & Compliance: Perform equipment validation and ensure strict adherence to GMP, ISO, and safety standards. Continuous Improvement: Identify and implement CIPs (Continuous Improvement Projects) to reduce energy costs and improve equipment efficiency. Contractor Oversight: Supervise external maintenance providers and specialized contractors. Requirements Technical Skills: Proven ability in mechanical/electrical troubleshooting and basic equipment re-design. Compliance Knowledge: Strong understanding of GMP, EHS regulations, and equipment validation. Mindset: A self-starter who can manage budgets and engineering metrics while working collaboratively with plant leadership. Job Type: Full-time Work Location: In person #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 (CQV) to the life sciences and technology sectors. Our client is seeking an experienced Project Engineer to support the execution of capital projects at our GxP-compliant manufacturing facility, including cleanroom construction, facility upgrades, and servce integration. This position reports directly to the Project/Facility Manager and will oversee technical coordination, design review, and site execution across CSA, HVAC, BMS, and other critical systems. Key Responsibilities: Support the planning, coordination, and execution of engineering and construction projects on a GxP-regulated site. Supervise and manage CSA (civil, structural & architectural) works, including cleanroom environments. Oversee the installation, integrations, and commissioning of HVAC and BMS systems to cleanroom and GMP standards. Participate in cross-functional design reviews, ensuring technical compliance and alignment with project specifications. Interpret and work from P&IDs, process layouts, and engineering drawings. Provide or review CAD drawings and markups, during design and construction phases. Ensure all construction activities meet GMP/GxP compliance, cleanroom standards (ISO 14644), and site protocols. Liaise with contractors, vendors, and internal stakeholders to coordinate multidisciplinary works on site. Support contract management, including scope, variations, scheduling, and performance monitoring. Monitor construction progress and proactively report issues or risks to the Project/Facility Manager. Ensure health, safety, and environmental standards are strictly followed. Ad hoc duties as required. Job Specific Technical, Functional and Professional Competencies: Strong communication and coordination skills with both internal teams and external contractors. Strong knowledge of CSA works and site supervision in a multidisciplinary construction environment. Education and Experience: Proficiency in CAD software (e.g., AutoCAD) and ability to interpret technical drawings and schematics. Ability to read and understand P&IDs, mechanical, electrical, and architectural drawings. Familiarity with ISO cleanroom standards, commissioning, and validation processes is desirable. Relevant engineering degree or trade background in Mechanical, Civil, or Building Services preferred. #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. 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 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. Job Type: Full-time #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
This is a 4 day work week role, Tues - Fri night shifts only 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. Join our engineering team to ensure peak operational performance and safety across our manufacturing and plant equipment. This role balances hands-on technical troubleshooting with high-level project coordination and continuous improvement. Core Responsibilities Maintenance & Reliability: Execute day-to-day preventative and demand maintenance for manufacturing equipment and plant utilities (HVAC, water systems, etc.). Troubleshooting: Perform advanced mechanical and electrical troubleshooting to minimize downtime and hit production goals. Project Engineering: Coordinate equipment installations, commissioning, and process upgrades. Prepare Capital Expenditure (CapEx) requests. Validation & Compliance: Perform equipment validation and ensure strict adherence to GMP, ISO, and safety standards. Continuous Improvement: Identify and implement CIPs (Continuous Improvement Projects) to reduce energy costs and improve equipment efficiency. Contractor Oversight: Supervise external maintenance providers and specialized contractors. Requirements Experience: 4+ years in an engineering/maintenance role Technical Skills: Proven ability in mechanical/electrical troubleshooting and basic equipment re-design. Compliance Knowledge: Strong understanding of GMP, EHS regulations, and equipment validation. Mindset: A self-starter who can manage budgets and engineering metrics while working collaboratively with plant leadership. #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.
