A pharmaceutical company in Ireland is searching for a Qualification; Validation Engineer to join their team in County Waterford. This critical role involves overseeing Process Performance Qualification activities to ensure compliance with international quality standards and regulations. The ideal candidate should have a degree in a science field, experience in a GMP environment, and a strong ability to work in cross-functional teams. The position demands excellent project management and communication skills, ensuring the delivery of high-quality outcomes. #J-18808-Ljbffr
Purpose We are seeking an experienced Qualification; Validation Engineer – Process Performance Qualification to join our Qualification and Validation Team. In this critical role, you will be responsible for executing Process Performance Qualification (PPQ) activities in accordance with Company global quality standards and applicable regulatory requirements. The role supports the successful delivery of process validation lifecycle activities (Stage 1, Stage 2, and Stage 3) for commercial manufacturing, ensuring that processes consistently produce product meeting predetermined specifications and quality attributes. It works cross‑functionally with MSAT, Operations, Quality Control and Quality Assurance to ensure PPQ readiness, execution and reporting are delivered to the highest standards, in full compliance with cGMP, FDA, EMA and ICH guidelines. Responsibilities Author, review and execute PPQ protocols and reports in alignment with Company global standards and regulatory expectations. Define PPQ strategy including batch numbers, sampling plans, acceptance criteria and statistical approaches. Contribute to the development and maintenance of the Process Validation Master Plan (PVMP). Support lifecycle management changes requiring PPQ, including technology transfers and post‑approval changes. Develop and participate in risk assessments to evaluate process risks and define appropriate control strategies. Apply risk‑based approaches to PPQ study design, sampling strategies and acceptance criteria justification. Ensure timely closure of PPQ‑related deviations and CAPAs prior to and following PPQ execution. Maintain accurate and audit‑ready documentation throughout the validation lifecycle. Work closely with MSAT, Manufacturing Operations, Quality Control and Quality Assurance to ensure alignment on PPQ strategy, execution and outcomes. Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines. Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise. Provide training and technical guidance to operations personnel, validation associates and cross‑functional team members involved in PPQ activities. Design and execute Continued Process Verification (CPV) programs. Requirements Degree in science (e.g. Chemistry, Microbiology or IT preferred) or engineering (Chemical, Mechanical, Electrical). Minimum 3–5 years of experience in pharmaceutical manufacturing, process validation or quality assurance in a regulated GMP environment. Demonstrated hands‑on experience in Process Performance Qualification (PPQ) design, execution and reporting. Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls). Natural influencer who works well as part of a multifunctional team. Highly motivated and self‑resilient. Adaptable and flexible, with a pragmatic problem‑solving mindset. Strong understanding of process validation principles and lifecycle approach; knowledge of cGMP regulations: FDA 21 CFR Parts 210/211, EU GMP Annex 15, FDA Process Validation Guidance (2011) and EMA process validation requirements, working knowledge of ICH Q8, Q9, Q10 and Q11 guidelines. Knowledge of statistical methods applied to process validation (e.g. process capability, statistical sampling). Familiarity with qualification of equipment, utilities and manufacturing systems. Experience with deviation management, CAPA and change control systems. Excellent project management capabilities with the ability to manage multiple priorities. Strong communication skills with the ability to influence at all levels of the organization. Strategic thinking with a focus on balancing compliance requirements with business needs. #J-18808-Ljbffr
A recruitment agency is seeking a Construction Project Manager for a substantial project in Dublin's Pharmaceutical Industry. The role involves oversight and planning of construction works, ensuring safety and quality in compliance with regulations. Ideal candidates will possess strong communication and leadership skills, along with experience in a similar construction environment. The ability to collaborate with various stakeholders and work to tight deadlines is essential. This position promises a dynamic work environment. #J-18808-Ljbffr
A leading recruitment firm seeks a CQV engineer for various capital and equipment lifecycle projects in Dublin. The ideal candidate will have over 6 years of experience in validation and commissioning within the biotech/pharmaceutical industry. Key responsibilities include ensuring compliance with GMP standards, coordinating qualification activities, and supporting new product introductions. Strong knowledge of risk management and sterile processes is essential for success in this role. #J-18808-Ljbffr
Purpose Our Biologics facility has 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. Responsibilities Liaise daily with cross-functional teams to collaboratively and actively 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 quickly to unplanned events and technical issues. Perform real‑time exception review by maintaining on‑the‑floor operations support during manufacturing. Support the site's 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. Requirements 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. #J-18808-Ljbffr
Key Responsibilities Assist with audits for a range of clients across different industries. Support the delivery of audit and accounting tasks within deadlines, ensuring clear communication with clients and colleagues. Participate in planning, executing and completing audit assignments in line with established professional standards. Help maintain strong, positive client relationships, offering support throughout the audit process. Conduct research to answer client queries and assist with technical matters. Contribute to the delivery of high‑quality auditing services and ensure compliance with industry and firm standards. Support the team in ensuring audits are completed on time and to a high standard. As the business continues to grow, take advantage of opportunities for learning, development and progression. Skills & Experience ACA or ACCA qualified. Experience in a similar practice environment preferred. A passion for delivering an excellent client experience. Strong technical skills and excellent attention to detail. Clear and confident verbal and written communication skills. A motivated, effective team player with a proactive approach. #J-18808-Ljbffr
A recruitment agency is seeking an Audit Assistant to support the delivery of audit and accounting tasks for various clients. The ideal candidate will be ACA or ACCA qualified, with a passion for client experience and strong technical skills. Responsibilities include assisting with audits, maintaining positive client relationships, and conducting research to answer queries. This role offers opportunities for learning and development in a dynamic environment. #J-18808-Ljbffr
Description This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours. Responsibilities Environmental Monitoring of Grade 8/9 Cleanrooms Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators Reading of Environmental Monitoring Plates Bioburden testing of water & disinfectants Writing technical reports Water sampling Testing of In Process samples such as Protein Concentration, Density & pH Requirements Bachelors degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Experience working in an aseptic cleanroom performing Environmental Monitoring Proficient in the use of LIMS & LMES Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage Flexibility - the EM role often encounters changing priorities on a daily basis Problem solving skillsI Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time results Works under minimal direction Work is guided by objectives of the department or assignment Follows procedures Refers to technical standards, principles, theories and precedents as needed May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies Shift Patterns Shift Patterns: This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours. Two shift patterns: Two days followed by Two nights - from 07:00 to 19:00 & 19:00 to 07:00. #J-18808-Ljbffr
Purpose: This job description is for a Clean Utilities Engineer with previous relevant experience of Pretreatment Systems, Clean Steam, WFI and Process Air generation and distribution systems, to provide client side design input at Detailed Design, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building to be located at the Facility. The scope of the role also includes design input and support during the project phases for various ancillary areas such as the existing Warehouse, a new -30Deg Coldroom, Laboratory reconfigurations and general site infrastructure, which are all collectively managed as part of the project. The position is a hybrid position with an on-site (3 Days) and remote working element. As design progresses, attendance at A&E offices will also be required, and these will count as on-site days. Due to the nature of the role, the Clean Utilities Engineer will also be required to support FAT's at vendor sites at times during the project. Responsibilities To support the company client side design team in its efforts associated with the Facility To provide technical expertise working with other project stakeholders, in order to achieve design deliverables To track, manage and communicate adherence to discipline project milestones To coordinate client side clean utilities (Clean Steam / WFI / CA) design by liaising with Site SME's and the Engineering Technical Authority (ETA) To assist client side design reviews in the area of Clean Utilities for the project To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectations To input into Technical Assessment in support of the instrumentation framework, and/or procurement agreements. To participate in design reviews, model reviews, etc., and to input on technical elements of the design To execute Drawing, URS, HDS, SDS, Equipment & Instrument Specifications and other reviews associated with the Clean Utility installations. To participate in CMSAT's / Loop checking, including any trouble shooting activities To provide input and assistance to Automation, C&Q and Validation in terms of equipment packages as required. To participate in the design reviews and specifications review of any Vendor Package Equipment in the Facility. Provide attendance / assistance for FAT's / SAT / C&Q and Validation activities at various locations, site or Vendor, as required To provide input into the calibration program for clean utilities. To coordinate with site Metrology Group to ascertain calibration requirements and to ensure the execution of calibrations, both equipment and field instruments, in line with these requirements. To liaise with the site Maintenance Group and to ensure that any data gathering required to support the MAXIMO system requirements. To provide input / direction into schedule and cost discussions, as required, in order to meet the project objectives as defined by the Design Manager, Project Manager and Steering Committee, or designees. A site presence will be required during construction. This will involve oversight / supervision of the Clean Utilities element of the project. Requirements Minimum of 5 years of experience in pharmaceutical design / build / commission / startup with direct responsibility for Engineering Documentation, Project Execution or Facility Design. Direct experience in a similar scale project. Ability to challenge, defend and present technical aspects of design and commissioning. Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent. #J-18808-Ljbffr
A leading recruitment agency is seeking a qualified candidate for a role focused on environmental monitoring in cleanrooms supporting 24/7 operations. Applicants should have a Bachelor's degree in a science discipline and experience in biopharmaceutical QC. Responsibilities include conducting tests, writing reports, and working under regulatory compliance standards. Ideal candidates demonstrate strong problem-solving skills, leadership, and the ability to adapt to changing priorities. #J-18808-Ljbffr
