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.
~Remote~ Program Engagement Lead (Datacenter) 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 sciences & technology companies who entrust in us to deliver their most strategic and important projects. We are seeking an experienced and driven Program Engagement Lead with construction experience to lead the successful deployment of data centre programs. Job Responsibilities Program Management: Oversee multiple data center construction projects simultaneously. Develop and manage project schedules, budgets, and resources. Track project progress and identify potential delays or issues. Implement risk management strategies. Ensure projects are delivered on time, within budget, and to the required quality standards. Coordinate with internal and external stakeholders, including engineers, architects, and clients. Process Improvement: Identify opportunities to improve contract management and program management processes. Develop and implement standardized procedures and best practices. Contribute to the development of the company's data center construction expertise. Contract Management: Review, draft, and negotiate contracts with subcontractors, vendors, and suppliers. Ensure compliance with contract terms and conditions. Identify and mitigate contractual risks. Manage contract changes and variations. Develop and maintain strong relationships with vendors and subcontractors. Qualifications: Bachelor's degree in Engineering/Business/Supply Chain/ Construction Management, Engineering, or a related field. Experience in contract management and program management within the construction industry. Proven ability to manage complex projects and deliver results. Excellent communication, negotiation, and interpersonal skills. Proficient in project management software (e.g., MS Project, Primavera P6). Experience with risk management and mitigation strategies. PMP certification is a plus. Job Type: Full-time Experience: Program Management: 3 years (preferred) Work Location: Remote #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
Digital Transformation Project Manager GerTEK Project Management & Engineering Location: Westport About GerTEK GerTEK is a leading engineering consultancy. We partner with the world's largest life science and technology companies to deliver their most strategic and high-impact projects. Job Overview We are seeking a Digital Transformation Project Manager to lead our client's journey toward Factory 4.0 at their Westport site. You will coordinate a portfolio of digital initiatives designed to elevate operational efficiency and optimize manufacturing processes through cutting-edge innovation. Key Responsibilities Portfolio Management: Coordinate digital transformation projects, liaising with site SMEs and global teams. Strategy & Collaboration: Work with leadership and cross-functional teams (IT, Ops, QA) to align digital strategies with business goals. Business Case Development: Drive value analysis and support long-range financial planning and capital acquisition. Stakeholder Engagement: Act as the "voice of operations" in technical forums and communicate project milestones to stakeholders. Change Management: Lead strategies to ensure high user adoption and successful system integration. Performance Tracking: Establish and monitor KPIs to measure the success of digital initiatives. Compliance: Ensure all projects meet relevant industry regulations and standards. Qualifications Education: Bachelor's degree in Engineering, IT, Business Administration, or a related field. Experience: Proven track record in digital transformation and project management (Manufacturing or Biopharma preferred). Financial Acumen: Experience in budgeting, financial planning, and business case development. Process Improvement: Knowledge of Lean, Six Sigma, or similar methodologies. Tech Savvy: Strong interest/knowledge in Industry 4.0 (IoT, AI, Robotics). Skills: Exceptional multitasking, analytical problem-solving, and stakeholder influence skills. Preferred Qualifications Master's degree in a related field. Certifications: PMP, Lean Six Sigma Green/Black Belt, or Industry 4.0 credentials. Direct experience leading digital manufacturing or "Smart Factory" projects. Why Join GerTEK? By joining GerTEK, you will be at the forefront of industrial innovation, working on projects that define the future of life sciences and technology. #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) days - 39 hours per week; 08:00 - 16:30 (Friday finish at 15:30) 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 AbbVie 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 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 an Operational Excellence Specialist for our Sligo based Client. Reports to: Supply Chain & Business Systems Manager Job Summary: The function of the Operational Excellence Specialist is to support implementation of Lean Six Sigma and continuous improvement programs throughout the organization. The function of the OpEx specialist is to support implementation of Lean Six Sigma and continuous programs throughout the organization. The job entails supporting internal teams of network change agents to identify opportunities to significantly reduce operating costs, improve efficiency and lead the implementation efforts to achieve these improvements. Responsibilities: Responsible for executing continuous improvement efforts throughout the company to meet service, quality and cost objectives Support excellence in the day-to-day management of the business through implementation and maintenance of daily management tools. Support functional leadership and assigned teams with development of both strategic project portfolios and detailed project plans Establish/maintain network of change agents and be the focal point for continuous improvement expertise and troubleshooting within all support functions. Apply the concepts, tools and training techniques of Lean, Continuous Improvement and Six Sigma philosophies Influence/motivate senior management to identify opportunities and apply Lean, Continuous Improvement and Six Sigma philosophies Support/motivate project teams to ensure timely and successful delivery of projects. Provide regular communication of project status to departmental staff and leadership Lead education and training, in partnership with the OpEx team. Requirements: Bachelor's degree required; preferred disciplines: Sciences, Engineering, Operations, Supply Chain Management, or Business Management. 1-3+ years' job-related experience. Lean Six Sigma Green or Yellow Belt is desirable. Technical/Business Knowledge -Job Skills Experience of working in a busy manufacturing environment is an advantage Strong Organizational and Planning skills Capability to prioritize and multi-task. Excellent interpersonal and communication skills. High accuracy and strong attention to detail Excellent teamwork skills Initiative and Innovation to generate and implement improvements EHS Responsibilities: Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities. Continually be conscious of your own safety and that of others, always complying with safety notices and barriers. Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve; Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve; Attend all required EHS training and medical surveillance programs. Wear PPE as required. #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 #Gertek 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 sciences & 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 #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. Company Profile Our client are currently undertaking significant capital expenditure projects to upgrade and enhance our Sligo facility's infrastructure and production capabilities. We require a dynamic and safety-focused Project Engineer to lead critical on-site projects. Role Overview The Project Engineer will be responsible for the end-to-end execution of site projects, from planning and contractor selection through to commissioning, handover, and final documentation. This is a highly visible, hands-on role requiring a proactive approach to managing safety, quality, and schedule, with a primary focus on site-based contractor and documentation management. Key Duties and Responsibilities 1. Project Delivery & Site Management Contractor Management: Serve as the primary point of contact for all on-site contractors. Manage daily work permits, tool-box talks, site access, and work sequencing to maintain project momentum and minimize disruption to plant operations. Progress Tracking: Monitor and report on project status, expenditure, and schedule against baseline, proactively identifying and mitigating potential delays or risks. Scope Control: Ensure all work adheres strictly to the approved project scope, specifications, and quality standards. Typical Projects: Lead and execute engineering projects including: Continuous Improvement (CI) upgrades (e.g., Blister Pack Line optimization). Installation and commissioning of Building Management Systems (BMS). Essential site infrastructure and utility Remedial Works. 2. Drawing, Document Control & Handover Drawing Management: Control the distribution and revision of all engineering drawings (P&IDs, Layouts, Schematics) to contractors and stakeholders. Redline Management: Implement a rigorous process for capturing and controlling redline (as-built) markups from site execution teams. Document Update: Coordinate the timely update of official project drawings and documentation to reflect the final installation, ensuring accurate records for validation and maintenance teams. Handover Documentation: Compile and manage the final documentation package, including manuals, maintenance schedules, operating procedures, and certification required for project closure. 3. Health, Safety & Compliance RAMS Management: Develop, review, and approve detailed Risk Assessment and Method Statements (RAMS) for all project activities, ensuring alignment with regulatory and company H&S policies. Safety Leadership: Champion a zero-incident culture on site. Conduct regular safety walks, enforce adherence to the permit-to-work system, and investigate any incidents or near-misses. Compliance: Ensure all project execution complies with relevant industry standards, building regulations, and environmental requirements. Candidate Profile & Essential Skills Education: Degree or equivalent qualification in an Engineering discipline (e.g., Mechanical, Electrical, Process). Experience: Minimum of 3- 5 years of experience in an on-site Project Engineering or Site Management role, ideally within a regulated environment (Pharma/Med Device highly desirable). Mandatory: Proven experience in managing contractors, controlling drawings, and developing/approving RAMS. CAD experience required. Location: Must be able to work 100% on-site in Sligo. Competencies: Excellent communication, negotiation, and leadership skills. Highly organized, methodical, and detail-oriented, particularly regarding documentation control. #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 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. #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
