A multinational pharmaceutical client is seeking a Quality Engineer to ensure that products meet approved specifications and regulatory requirements. This role involves auditing quality systems, managing corrective actions, and ensuring compliance with regulations. Candidates should have a degree in Engineering, Science, or Quality and at least 2 years of relevant experience in a highly regulated manufacturing environment. This position offers an initial 12-month contract with potential for extension. #J-18808-Ljbffr
A multinational biopharmaceutical firm is seeking a Validation Engineer for a 12-month contract in Westport, Ireland. The role involves overseeing validation processes compliant with regulatory standards and ensuring customer satisfaction in validation tasks. Candidates should possess a science-based or engineering degree and experience in the pharmaceutical industry. This hybrid role offers a chance to work on crucial validation projects while maintaining high standards of quality and compliance. #J-18808-Ljbffr
A multinational biopharmaceutical client is seeking an OpEx Business Analyst for a hybrid position in Cork. You will be responsible for designing, developing, and maintaining interactive dashboards using Power BI to support business decision-making. The ideal candidate has at least 18 months of experience with Power BI and strong skills in data visualization and analysis. This role offers a contract initially for 12 months with potential for extension. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a Quality Engineer on behalf of our multinational pharmaceutical client based in Sligo on an initial 12-month contract with strong potential to extend. Days Role Initially. Possibility of Shift in future. Job Summary To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements. To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice. Key Responsibilities Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements. Audit the quality system with other personnel where required. Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions. Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions. Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc. Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training. Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary. Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance. Ensure implementation and compliance with relevant Regulator requirements. Assist in the performance of validation activities at the site. Ensure Quality System documentation is thorough, complete, and compliant. Ensure compliance with training requirements is maintained. Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment. Inspect incoming products and manage the supplier Quality relationship. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site. Complete in-process and final release product testing per the relevant approved specifications and procedures. Where required. Review batch records, ensuring documentation is compliant with requirements. Complete disposition decision for the batch. Participate in Risk Management activities as required. Essential Requirements Degree in an Engineering, Science, Quality or other discipline Desired Requirements A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable. Experience Required 2 years plus experience in the day‑to‑day operation of the quality system in a highly regulated combination product/device manufacturing environment. Technical/Business Knowledge Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable. Experience in an injection moulding or tooling environment is desirable. EHS Requirements 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 EHS system. Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system. Attend all required EHS training and medical surveillance programs. Wear PPE as required. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting OpEx Business Analyst on behalf of our Multinational Biopharmaceutical client based in Cork (Hybrid) on an initial 12-month contract with huge potential to extend. A Business Analyst specialising in creating accurate, interactive and user-friendly dashboards using Microsoft Power BI and other approved and available digital platforms. Responsible for designing, developing, and maintaining digital dashboards that provide insights and data visualization to support business decision-making and performance improvements. Key responsibilities of an OpEx Business Analyst include: Gathering requirements from stakeholders and understanding their data visualization needs. Designing and developing interactive dashboards using company approved digital tools such as Power BI. Creating data models and connecting to various data sources to extract and transform data. Implementing data visualization best practices to present data in a clear and meaningful way including drill-throughs and analytical capabilities. Collaborating with data analysts and business users to ensure the accuracy and relevance of the data displayed in the dashboards. Optimizing dashboards for performance and usability. Creating and publishing reports and dashboards to the Digital Tool such as Power BI for sharing with stakeholders. Providing training and support to end-users on how to use and interpret the dashboards. Desired System Skills:18 month’s experience in one or more of the following: Basic C++, PowerApps, PowerBi, Power Automate, JSON, HTML, Dataverse, SQL Server, SharePoint Relational Database Management Experience with Visual Studio, Visual Studio Code, Power Platform CLI Deliverables include, but are not limited to: Balanced Scorecard Reports Qualification Reports Integrated Survey and Reporting tool Training Delivery In addition to technical skills in Digital Tools such as Power BI, the Business Analyst should have a good understanding of data analysis and visualization principles, as well as strong problem-solving and communication skills. They should also stay updated with the latest features and updates in Power BI to leverage its full potential in creating impactful dashboards. Additional tasks might be required. People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a QC Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11‑Month contract with potential to extend. Site‑Based Shift Role. Week 1: Mon 7:00‑17:00; Tue 7:00‑17:00; Wed Off; Thu Off; Fri 7:00‑17:00; Sat 7:00‑19:00 or 9:00‑21:00 (alternate as agreed between shift mates); Sun 7:00‑19:00 or 9:00‑21:00 (alternate as agreed between shift mates). Week 2: Mon Off; Tue Off; Wed 7:00‑19:00; Thu 7:00‑19:00; Fri Off; Sat Off; Sun Off. Responsibilities Comply with and execute CGMP/GDP in the performance of day‑to‑day business activities. Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day‑to‑day business activities. Attend and successfully complete applicable CGMP training. Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products. Work collaboratively to ensure a safe and compliant culture in Carlow. Participate in driving a high‑performing & inclusive culture, stimulating personal growth & development. May be required to perform other duties as assigned. Ensure that adequate processes and procedures are in place and followed for all Quality activities. Where required, work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and/or oversight) as required per business needs & if needed. Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic products activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP). Develop and maintain effective cross‑functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products is in compliance with cGMP and the associated regulatory requirements. Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site. Support business critical projects related to the Quality Department. Perform laboratory testing and/or materials inspections to determine specification conformance. Perform all required analytical, microbiological and control testing to support the site. Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Qualifications Bachelor’s Degree or higher preferred; ideally in a related Science discipline #J-18808-Ljbffr
A leading recruitment firm is currently seeking a QC Analyst for a multinational biopharmaceutical client based in Carlow. This role involves ensuring compliance with CGMP/GDP, conducting laboratory testing, and maintaining a safe laboratory environment. The ideal candidate should hold a Bachelor's Degree in a science discipline. This position is site-based and involves working shift patterns as needed. #J-18808-Ljbffr
Orion Group Life Sciences is recruiting a VALIDATION ENGINEER on behalf of a multinational biopharmaceutical client based in Mayo for an initial 12‑month contract with potential extension. Hybrid role. Purpose The Validation Department is responsible for the qualification/validation of all CGMP equipment, systems and processes utilized for routine operation at the Westport manufacturing site. It also handles revalidation of critical systems & processes. The Validation Engineer ensures customer satisfaction with each revalidation, validation and project work. All activities are performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. Schedule compliance is achieved by engaging with senior management and impacted BU’s, ensuring projects are prioritized as required. Responsibilities Over‑see, coordinate, guide and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with relevant engineers, to ensure all validation requirements are met for any new process, equipment or change. Act as departmental point person on validation projects, completing all associated documentation in line with corporate and regulatory expectations, compiling, authorizing and filing documents in a timely and organized fashion. Coordinate with other validation engineers to achieve compliance by reviewing and approving documentation and coordinating the work. Participate in risk assessment processes for all business units and in the design review process for all business units. Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.). Facilitate the PQR review process, regulatory review process and laboratory equipment review process as per current rota. Keep abreast of current and changing regulatory guidance for the relevant validation areas, providing support for audit preparation, direct audit interaction and involvement in audit response. Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department and achieve the company’s quality objective through continuous improvement and conformance to quality standards. Attend department and APEX meetings and participate in quality and safety initiatives. Provide support for audit preparation, direct audit interaction and involvement in audit response; participate in site internal and external audit program, including periodic review. Qualifications Bachelor’s degree required in a science‑based or engineering discipline. Experience in a pharmaceutical company. Excellent project‑management skills. Proficiency in Microsoft Office suite. Critical thinking and problem‑solving skills. Ability to articulate clearly when dealing with internal and external bodies. Excellent conflict‑handling skills. Expertise in relevant subject‑matter areas (e.g., equipment validation, sterilisation validation, facility validations, aseptic). #J-18808-Ljbffr
A multinational pharmaceutical company in Sligo is looking for a QC Laboratory Support Supervisor to oversee compliance and laboratory performance. This role involves coaching analysts, enhancing team efficiency, and ensuring adherence to regulatory standards. A 3rd level qualification in a science discipline and a minimum of 4 years' experience in analytical roles with expertise in HPLC and GC are required. The position is onsite with potential for extension beyond the initial 9-month contract. #J-18808-Ljbffr
