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. We are seeking highly experienced EHS Engineers to join our leading global healthcare client based in Co. Sligo. Job Responsibilities Ensure environmental, health & safety (EHS&E) global management standards are met, and all EHS&E procedures are adhered to. Ensure compliance with safety and environmental legislation, Procedures and Standards by ensuring all required EHS&E documentation is up to date and readily available. Play a leading role in investigations and remedial actions associated with all EHS&E related accidents/incidents. Co-ordinate inspections by regulatory bodies as required. Assist in the co-ordination of contractors where there is an EHS&E impact, and in accordance with local legislation. Ensure all EHS&E incidents are investigated to establish causation and resolution. Ensure EHS&E audits are conducted, and all issues effectively closed out. Educate and engage employees in efforts to optimize EHS&E performance. Promote continuous improvement in all environmental and safety matters. Ensure permit completion in compliance with laws and regulations. Assist in workstation assessment program. Deliver EHS&E Training Courses. Key requirements Qualification in an Environmental Science/ Occupational, safety and health or related discipline. Minimum of 3 years health and safety experience within in a highly regulated environment. Energy and drive to deliver. Achievement oriented. #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 is an engineering consultancy company specializing 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 us to deliver their most strategic and important projects. Title Complaint Processing Analyst Purpose The Complaints Processing Analyst will report directly to the complaints manager and coordinate the handling of customer complaints investigations, trending, and analysis for all commercial & clinical products, working with internal departments on Root Cause Problem Solving cases to ensure implementation of robust Corrective/Preventive action plans and tracking these to completion. The Complaints Processing Analyst is responsible for opening, tracking and maintaining records for complaints received and data entry into complaint handling system. The Complaints Processing Analyst is responsible for coordinating cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause including the coordination of laboratory testing of complaint samples. Responsibilities Assure complaint records meet global requirements. Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing medical complaints that involve a non-medical quality related problem. Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing, and good documentation. Identification of potentially reportable events and notification to appropriate functional groups and management. Serve as main resource for the team or a subject matter expert on complaint handling. Liaise with site complaint investigation team to achieve closure of complaint cases in a timely manner. Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy. Requirements Bachelor Degree in Sciences or related field. 1-2 years previous experience in pharmaceutical industry. Previous experience in the use of SAP and Trackwise and Document management systems is desirable. Knowledge of global regulatory requirements for pharmaceutical, medical device and combination products. Proficient computer skills including Word, Excel. Strong CAPA knowledge, decision making and critical thinking abilities. Excellent written, communication and interpersonal skills. Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures. Ability to work with cross-functional teams and to interact effectively with peers, management and customers. Good time management and organizational skills. #J-18808-Ljbffr
Gertek Project Management is seeking a Complaint Processing Analyst in Connacht, Ireland. The role involves coordinating the handling of customer complaints, conducting investigations, and ensuring compliance with global regulatory requirements. Candidates should have a Bachelor's Degree in Sciences or related fields and 1-2 years of experience in the pharmaceutical industry. Proficiency in SAP, Trackwise, and Microsoft Office is preferred, along with strong analytical and communication skills. #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 (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. 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. 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. Dept: Operations Must be flexible to work shift: Type of shift applicable (Monday to Friday) evening - 16:00 - 00:00 (Friday finish at 23:00) night - 00:00 - 08:00 (Friday finish at 07:00) Job Summary: To work as a team member in production/operations areas in line with all safety, regulatory and organizational requirements. Preparing equipment, work areas and materials and ensuring/verifying readiness of manufacturing operations Responsibilities: Preparation and operation of moulding and ancillary equipment. Preparation and operation of automated assembly and ancillary equipment. Preparation and operation of Pad Printing and ancillary equipment. Preparation and operation of manual assembly and ancillary equipment. Troubleshooting day to day manufacturing issues which may impact on efficiencies, safety or quality. Completion of quality checks and achieving production quality targets. Supplying materials to the operations and equipment in a timely and safe manner. Responsible for labeling and packing of components and finished products. Operating of Coordinate measuring equipment, and other advanced metrology equipment. Operate fully automated and complex computer-controlled systems, including robotic and vision system technology. Participate in divisional project team for New Product Introduction and Improvement Projects. Resetting equipment as necessary to ensure the manufacture of quality components. Team coordination to maximize the effectiveness of all of the team members. Documentation of all activities in line with GMP requirements. Cross training within the team and training of new members. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Execution of routine manufacturing documentation, commissioning and validation protocols on an ongoing basis. Ensuring compliance with the Quality, Regulatory, GMP requirements and adherence to all policies and relevant legislation. Ability to work on own initiative. Execute manual assembly and visual inspection as required. Qualifications: Essential Requirements Leaving Certificate or equivalent, desirable or relevant work experience Working knowledge of: Microsoft Office Suite beneficial. Desired Requirements 3rd level education. Job Type: Full-time #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.
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.
