QC Micro Technician Join our team in a dynamic Microbiology laboratory as a QC Micro Technician. We are looking for an enthusiastic and hard-working individual with strong attention to detail, problem-solving skills, and the ability to work independently or as part of a team. This is an exciting opportunity to contribute to our mission of delivering innovative health solutions. Responsibilities Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities. Perform laboratory testing to determine specification conformance and to support site targets, including but not limited to bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Maintain an adequate, qualified, and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Contribute to effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems. Highlight any discrepancies, deviations, or non-conformance in testing or work practices and support investigations as required. Ensure compliance with GMP and EHS guidelines at all times. Participate in training programs as required. Qualifications Required Minimum of Bachelors Degree or higher in a related Science discipline 1-2 years experience in a GMP laboratory environment Good knowledge of GMP, GLP, and aseptic technique. Proficient computer skills and technical writing. Strong interpersonal and communication skills. Preferred Experience in a microbiology laboratory setting. Familiarity with bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing.
Role Description The role available that will require experienced, energetic and committed engineers in the following areas: Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems Role Functions (Functions include, but are not limited to, the following) Bring energy, knowledge, innovation to carry out the following: Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Resolving technical issues encountered during study execution. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. Technical input into quality notification by authoring/reviewing/approving investigations. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Support continuous improvement through Lean Six Sigma methodologies. Serve as validation representative for cross functional projects and represent the validation team at global technical forums Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance Supporting regulatory audits and submissions as required. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Experience, Knowledge & Skills What skills you will need: In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. Knowledge of CTU equipment qualification Knowledge of thermal mapping equipment Thermal mapping skills Exception / Deviation Management and Change Control. Demonstratable experience of leading technical related projects. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable Evidence of continuous professional development is desirable. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate. Report, standards, policy writing skills required. Equipment and process validation. Sterile Fill-Finish processes and equipment. Proficiency in Microsoft Office and job-related computer applications required Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Knowledge and experience of the below areas will be considered advantageous Equipment Periodic Validation Equipment Validation Lifecycle Project Management Skills/Qualification Filter Validation & Container Closure Validation Autoclave/SIP Sterilisation Validation Dry Heat Sterilisation Isolator Qualification Vial and Syringe Processing Technologies Temperature Mapping Cleaning Validation Qualifications & Education Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. Skills: CTU Thermal Mapping Change Control Cleaning Validation Isolator Validation
The Senior EHS Engineer supports the site in implementing new Environmental, Health & Safety (EHS) Standards and driving compliance across operations. This role is responsible for developing implementation plans, coordinating with functional leaders, influencing key stakeholders, and ensuring successful adoption of EHS requirements. The position will lead the site's risk assessment programme and provides technical support for identified remediation projects to ensure a safe, compliant, and continuously improving workplace. Another focus area will be to provide EHS expertise to the site's Engineering Projects Portfolio and the Operational Readiness Programme. Key Responsibilities EHS Standards Implementation Support the rollout and integration of new corporate and regulatory EHS Standards into vaccine manufacturing, MSAT, utilities, labs, and support functions. Develop sitewide implementation plans including milestones, owners, and deliverables, monitor and report progress. Conduct gap assessments and develop robust action plans with functional leads to achieve compliance. Ensure EHS risks are appropriately controlled during changes to processes, utilities, equipment, and facility infrastructure. Stakeholder Engagement & Influence Partner with Operations, Quality, Engineering, MS&T, Utilities, and Maintenance to embed EHS expectations into daily operations. Coach leaders and staff to strengthen EHS accountability and decision-making. Deliver concise updates, dashboards, and risk insights to steering teams and site leadership. Influence behaviours to maintain a strong SafeByChoice and WorkReady EHS culture Risk Assessment Programme Leadership Lead the vaccine site's risk assessment programme, ensuring comprehensive hazard identification across: Manufacturing suites Equipment and machinery High hazard utilities (steam, chilled water, gases) Laboratory operations and biological agent handling Ensure consistent methodologies across the site and train teams in high-quality risk assessment techniques. Remediation Project Support Support investigation findings, audits, and risk assessment outputs by developing effective corrective and preventive actions. Partner with Engineering and Operations on root cause analysis and technical evaluation of remediation solutions. Ensure closure of remediation actions is timely, verified, validated, and sustainable. EHS Support for the Engineering Projects Portfolio Provide full lifecycle EHS support to the site's project portfolio, including: Construction Phase Oversee EHS requirements for contractors and construction activities. Support site permitting, method statement reviews, and safe system of work planning (e.g., hot work, confined space entry, LOTO). Commissioning & Startup Ensure safe integration of new equipment or systems into vaccine operations. Support pre-startup safety reviews and verify closure of EHS actions before handover. Compliance & Continuous Improvement Support adherence to regulatory requirements Participate in internal/external audits, including regulatory inspections. Analyse site EHS performance, incidents, and trends to identify targeted improvement opportunities. Qualifications & Experience Required Qualification in Environmental Engineering, Safety Engineering, Occupational Health & Safety, Chemical Engineering, or related technical field. 5+ years' EHS experience within pharmaceutical, biotech, vaccine, medical devices or other related industry Strong understanding of EHS standards related to high hazard work, equipment safety, chemical management, contractor management. Demonstrated experience supporting engineering projects and leading risk assessment processes. Proven ability to influence stakeholders and drive cross-functional alignment. Key Competencies Strong communication and influencing skills Excellent organisational and project management skills Analytical, detail-oriented, and able to prioritise effectively Proactive, collaborative, and solutions-driven
What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: Proficient in working with raw materials and packaging components. Request, update and maintain as required supplier/material details to support new qualifications and implementing change control, while adhering to relevant operational procedures and controls. Maintain the company approved intranet application that is the official system of record to store the Approved Supplier List, Materials, and Supply Chains, to ensure accurate data and audit ready. Demonstrated strong individual and team-working skills including the ability to work effectively and influence decisions across functions and with suppliers. Excellent communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers. Actively promotes and participates in cross functional teamwork as an influential team member. Supports the manufacturing process by leading investigation of component/material quality issues - work with quality, materials, manufacturing and suppliers to resolve issues and minimise impact to the business. Demonstrated knowledge in quality systems in support of deviations, supplier complaints and problem solving. Develop a knowledge of the new materials being purchased. Preparation of data for entry of purchase orders, expediting and progressing change control with suppliers to meet delivery times and respond quickly to changes in the business environment and external supply chain. Assist with supplier performance appraisal and monitoring, and improvement plans. Establish and maintain a good working relationship with suppliers, forwarding agent and courier. Resolution of supply problems, general queries and queries relating to payment invoices. What skills you will need: In order to excel in this role, you will more than likely have: Bachelor of Science, Engineering or related subject with 2-4 years experience in a quality, technical discipline, or supply chain with 2 years of experience in SQM (supplier quality management). Previous experience in a Pharma / regulated environment within a manufacturing environment required. Min 2 years experience in new product/process. The 3 C's of Change Management, Communication, Collaboration and Commitment. Project Management - Analyzing the process and making corrective and preventive changes to stop recurring issues in a project. Ensuring the change requests are prioritised and aligned with the project management plan. SAP, Excel, Word, are essential. Lean Six Sigma (or similar) training a distinct advantage. Analytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks. Previous purchasing experience - highly advantageous Skills: SAP Pharma Purchasing Experience process improvement
Job Purpose Our?Biologics facility in Dunboyne have a great opportunity for a QA Operations Specialist to join the team. Reporting to the QA Operations Manager within Global Development Quality (GDQ), the QA Specialist role will support the Quality Assurance activities at Research & Development Division facility. You will be a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. Please note this is a shift role. Key Accountabilities Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner. Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented to meet deadlines. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations. Perform material disposition of incoming material to the site. Assist in the development of training curricula and records for the QA Operations group, providing SME training on Quality Assurance SOPs as required. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site. Participate in and support risk management activities in line with relevant guidance and best industry practice. Ensure the escalation of compliance risks to management in a timely manner. Keep informed of the latest developments from regulatory authorities in relation to quality compliance. Support cross functional departments by responding to quickly to unplanned events and technical issues. Perform real time exception review by maintaining on the floor operations support during manufacturing. Support the sites walk-through/ GEMBA process as assigned. Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards. Educational and Experience Requirements In order to excel in this role, you will more than likely have: Degree qualification (Science/Quality/Technical). 4-7 years experience,?ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Experience with PAS-X, SAP and Veeva is desirable. Project Manager capability with significant understanding of Operations and/or Laboratories. Demonstrated experience in QRM, Investigations, problem solving as a Quality SME. Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Strong attention to detail and precision in preparing and reviewing GMP documentation. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Experience in direct interactions with regulatory agencies during site inspections. Skills: PAS-X SAP QRM FDA GMP
A fantastic opportunity has arisen for a HR Business Partner. You will provide HR Business Partner support as well as specialist support in relation to employee relations and industrial relations. You will play a key role in shaping the culture and people strategy, partnering closely with the Site Leadership Team as well as a highly talented Ireland HR Team, comprised of a team of experienced HRBPs working across our growing footprint in Ireland. Bring energy, knowledge, innovation to carry out the following: Works with business leaders to champion a high-performance culture and to create an environment of trust, dignity and respect, where behaviours are aligned to the Company values. Sponsors and manages organisational change projects and their associated people implications. Ability to contribute to business strategy by providing an aligned HR Strategy that supports its effective execution. Partners with business leaders in developing people plans to support the business strategy. Support the development of line managers' knowledge, skills and leadership effectiveness through coaching. Develop HR practices that act as strategic differentiators. Key influencer and coach of leaders across the business. Lead the employee/industrial relations area. Build on the sites progressive partnership approach to ER/IR. IR/ER strategy enhancement and execution. What skills you will need: In order to excel in this role, you will more than likely have: 5 years+ experience in an HR Business Partner role. Background and demonstration of IR/ER strategy development and execution. Experience working in a large multi-national manufacturing environment would be preferable. Bachelors degree. CIPD qualification or relevant Masters degree. Highly effective communicator and collaborator, with the ability to build trusted partnerships and to work effectively with people at all levels. Ability to manage multiple projects and initiatives through to successful delivery. Highly effective at handling complex employee relations issues. Proven facilitation, negotiation and mediation skills. Skills: CIPD Strategy Development Multi-national
Role Description A fantastic opportunity has arisen for an Associate HR Business Partner. In this role you will provide strategic business partner support to the Carlow site and global support functions. You will have opportunities to support a range of assignments across the Ireland HR Network including but not limited to policy development and Compensation/ Benefits. Primary Responsibilities: Provide Strategic BP support across client groups in driving & realising their people strategy. Support delivery of annual performance and talent processes as well as succession planning; provide coaching and feedback on how to improve individual performance to meet business objectives. Proactively manage employee relations to ensure a highly effective workforce capable of achieving business goals. Industrial Relations; model and champion effective partnership with our unions. Support and coach the business to ensure successful management of issues. Represent the company in dispute resolution. Work collaboratively across site and as part of the Irish HR network to provide support in implementing various projects as required. Develop, implement and update local and country HR policies and support communication of same. Work collaboratively with management to provide advice and guidance on compensation and benefits and assist with salary and bonus administration. Lead critical updates to people managers and SLT at monthly forums. Provide SME knowledge to ensure seamless delivery of T&A function (Kronos) of HR. Provide ad hoc administrative support including compliant management of department purchase orders. Role Functions Experience, Knowledge & Skills 2-3 years experience in an HR role, ideally working in a large multi-national environment. Ability to build partnerships and to work effectively with people at all levels. Highly effective communicator with the ability to influence outcomes at all levels of the business. Ability to project manage multiple projects and initiatives through to successful delivery. Effective at managing multiple stakeholders. Good knowledge of Irish and European employment law framework. High level of independence and initiative while working effectively as part of the team. Strong administration skills. Qualifications & Education Bachelors degree; CIPD qualification or relevant diploma and experience Skills: employment law CIPD Kronos
The Small Molecule Process Cleaning Representatives will assist the Small Molecule Cleaning Process Team (SMTPT) in planning, executing and the continuous improvement of Cleaning across the Small Molecule business Key Responsibilities: Responsible for the delivery of the Production Cleaning including but not limited to: Lead the Morning and Evening Handover meetings during Cleaning Deliver the execution of Cleaning on schedule Responsible to meet business plan for Cleaning cycle times, identify bottlenecks and own resolutions. Deliver all the documentation e.g. Tickets, Viz Boards, etc. associated with Cleaning Track progress and downtime during Cleaning collecting data that will improve future Clean-ups Prepare Swab Kits and Cleaning Wipes Ensure all equipment and consumables are readily available well in advance of Clean-ups Participate in or lead After Action Reviews for Clean-ups Drive medium to long-term improvements in the Cleaning program based on external benchmarking / industry trends. Support the SMTPT in the development and ongoing execution of a Cleaning training program / education for the Process and Operations Teams. Generate Cleaning Campaign Summaries and present to Flow Improve efficiency on Cleaning processes and identify projects for improvements Support Operations Team Leader and SSL in planning and scheduling daily work. Support the Maintenance Planner by scheduling PMs and Work Orders into the Cleaning/Turnaround Schedule Equipment and process knowledge to be able to support trouble shooting Small Molecule Cleaning Process Team member attending weekly PT meetings Creating non-routine work instructions (attachments to Tickets, non-routine work instructions, etc.) with input from the Process Team. Organising/ completing non-routine sampling during Cleaning. Support the execution of Lean initiatives in the building associated with Cleaning Key Attributes: Technical knowledge of processing equipment and cleaning regimes (chemical, re-circulated washing, etc.) Knowledge of Small Molecule manufacturing processes and understanding of production schedules Interested in standardisation of Cleaning business systems across Small Molecule and benchmarking with internal and external colleagues. Continuous Improvement mindset i.e. always looking for a better, more efficient way Skills: Process Process Engineering
This is what you will do: The Senior Cleaning Validation Lead has primary responsibility in supporting the cleaning validation activities for the biological bulk drug substance (BDS) manufacturing process at the facility in Blanchardstown, Dublin. The SME will provide cleaning validation expertise and leadership to a team of specialists supporting technology transfer, cleaning validation, and routine monitoring of commercial manufacturing for Upstream and Downstream manufacturing. The candidate will be responsible for leading Cleaning Validation of new and existing drug substance (DS) manufacturing processes into the Dublin facility. The candidate will be required to work in close collaboration with Process Development, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful transfer and process qualification. You will be responsible for: To provide process expertise in the following disciplines: To provide cleaning expertise in Upstream and Downstream equipment: including parts washers, media vessels, bioreactors, centrifuge, depth filtration/clarification skids, buffer vessels, purification equipment including chromatography, ultrafiltration, viral filtration skids, downstream vessels and supporting process equipment To author and review cleaning related documentation, gap assessments, technical protocols and reports, and cleaning validation documentation, strategy documents Defend cleaning validation strategies and studies during regulatory inspections. Provide SME leadership to a team of specialists to ensure delivery of project milestones. To identify requirements for laboratory studies to support cleaning decisions, and to liaise closely with 3rd party Laboratories/Process Development / Procurement / MSAT to oversee the design and execution of cleaning studies To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale. May be required to work periodically out of normal business hours during periods of validation batch execution and provide on-call support to manufacturing if required. To provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into cleaning related deviations and resolution Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits. Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations. To author and review technical documents relating to cleaning activities for SOPs, master data, material specifications, APQRs, and or common technical document (CTD) sections and reports for regulatory agency submissions. To serve as a subject-matter expert (SME) on cleaning of Upstream and Downstream equipment and cleaning related support during regulatory agency inspections You will need to have: Minimum of 10 years experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations. Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous. Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change. Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant. Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings. Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements. Ability to drive for results independently and adapt to rapidly changing priorities. Experience of leading Cleaning Validation teams is advantageous. Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external. Detail orientated. Technical writing competency. Self-driven, able to prioritize, and to orchestrate multiple activities at once. Consistently demonstrate sound business judgment when making decisions. Ability to deal with ambiguity and complexity and influence others across levels of the organization. We would prefer for you to have: Minimum undergraduate degree in chemistry, biology, engineering, or related discipline. An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable. Experience of authoring CMC sections of regulatory submissions Previous leadership experience of Cleaning Validation activities Skills: cGMP MSAT Chemistry Engineering
Description: The position requires effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory partners. You will be responsible for: Developing and implementing TT Strategy including Process Validation, Control Strategy. This includes drug substance and drug product (biologic). Leading technical gap assessment & ensuring implementation of any associated mitigation activities. Authoring and reviewing project related documentation including process validation and comparability documentation. Reviewing approving supporting protocols and reports. Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with global requirements. Provide SME input to technical aspects of Regulatory filing and IR response. Providing support to Regulatory audits as needed. Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements. You will need to have: 6 years experience providing technology transfer project support to drug substance or drug product manufacturing. Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations. Comprehensive understanding of Technical/cGMP requirements for Tech Transfer activities. Ability to present and defend tech transfer topics during regulatory agency inspections. Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish. Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations. We would prefer for you to have: Bachelors degree in Science or Engineering, (or related field). Organized analytical thinker with strong attention to detail. Excellent oral and written communication skills, including technical writing. Ability to communicate technical and regulatory drivers with the proven capability of implementing TT projects. Skills: MS&T Process Validation Drug Substance Drug Product
