14491 Contract €55- €60 Per Hour Hybrid Waterford, Ireland Updated on: 09-04-2025 ROLE OVERVIEW A leading healthcare manufacturing company based in Ireland is seeking a dedicated Validation Engineer to join their team. This role offers the chance to support new product introductions, equipment qualification, and the site requalification program. As a Validation Engineer, you will ensure the ongoing validation and compliance of existing and new equipment, systems, and processes. KEY DUTIES AND RESPONSIBILITIES: Your duties as the Validation Engineer will be varied however the key duties and responsibilities are as follows: Designing, executing, and reporting on PV/Process Performance Qualifications. Designing, executing, and reporting on validation studies for equipment, systems, and processes. Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.). Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation. ROLE REQUIREMENTS: To be successful in your application to this exciting role as the Validation Engineer we are looking to identify the following on your profile and past history: Relevant degree in a scientific or engineering discipline. Proven industry experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector. A working knowledge and practical experience with troubleshooting validation issues, and a strong understanding of quality and compliance regulations. Key Words: Validation Engineer / healthcare manufacturing / pharmaceutical sector / equipment qualification / process validation / cGMP / FDA / EU regulations / aseptic processing / lyophilisation / sterilisation / depyrogenation Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career. #J-18808-Ljbffr
14455 Permanent Competitive Site Based Dublin, Ireland Updated on: 20-03-2025 ROLE OVERVIEW We are currently looking for a Principal Device Development Assurance Engineer to join a leading medical device company based in the Dublin area. As the Principal Device Development Assurance Engineer, you will be responsible for ensuring the highest standards in device development and compliance. KEY DUTIES AND RESPONSIBILITIES: Your duties as the Principal Device Development Assurance Engineer will be varied however the key duties and responsibilities are as follows: Support and provide guidance for device development programs through the design and development lifecycle for combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices. Establish, maintain, and provide guidance on the contents of Design History Files for development programs, including associated activity plans and timelines. Collaborate with, and influence, affiliate sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables. Support Risk Management activities for development programs through the implementation of ISO 14971:2019. ROLE REQUIREMENTS: To be successful in your application to this exciting role as the Principal Device Development Assurance Engineer we are looking to identify the following on your profile and past history: Relevant degree in engineering or science/life science. Extensive industry experience in medical device or pharmaceutical (with devices). A working knowledge and practical experience with device development and manufacturing operations activities for device or drug/device systems in a GMP environment. Key Words: Principal Device Development Assurance Engineer / Medical Device / Combination Products / Design Control / Quality Management System / ISO 13485 / ISO 14971 / GMP / Risk Management / Dublin / Pharmaceutical Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career. #J-18808-Ljbffr
14283 Permanent £65,000 - £75,000 Site Based Dublin, Ireland Updated on: 15-01-2025 We are currently looking for a Senior Device Design Engineer to join a leading Pharmaceutical company based in the Dublin area. As the Senior Device Design Engineer, you will be responsible for driving the design and development of innovative combination products, contributing to a diverse range of exciting projects. KEY DUTIES AND RESPONSIBILITIES: Your duties as the Senior Device Design Engineer will be varied; however, the key duties and responsibilities are as follows: Collaborate with multi-disciplinary teams to provide focused design input and develop technical specifications and functional designs for robust combination products. Create, review, and update detailed designs of components and assemblies, including documentation such as specifications, bill of materials, 3D CAD models, and part and assembly drawings. Lead problem-solving initiatives, identifying and mitigating risks within the design of combination products to control and minimise use-related, design-related, and process-related risks. Prepare technical documentation for a regulated industry, ensuring compliance with relevant standards and design controls. ROLE REQUIREMENTS: To be successful in your application to this exciting role as the Senior Device Design Engineer, we are looking to identify the following on your profile and past history: Relevant degree in mechanical engineering, product design, or equivalent. Proven industry experience in the development of drug delivery products and all stages of the product development process, through to commercialisation. A working knowledge and practical experience with preparing technical documentation for a regulated industry. Key Words: Senior Device Design Engineer / Mechanical Engineering / Product Design / Combination Products / Drug Delivery / Technical Specifications / 3D CAD Models / Risk Mitigation / Regulated Industry / Design Controls #J-18808-Ljbffr
14243 Contract Competitive Hybrid Clare, Ireland Updated on: 17-03-2025 We are currently looking for a CQV Engineer to join a leading pharmaceutical company based in the London area. As the CQV Engineer, you will be responsible for ensuring the commissioning, qualification, and validation of critical equipment. KEY DUTIES AND RESPONSIBILITIES: Your duties as the CQV Engineer will be varied; however, the key duties and responsibilities are as follows: Oversee the commissioning, qualification, and validation of Autoclaves, CTUs, and Depyro Tunnels. Collaborate with cross-functional teams to ensure compliance with industry standards and regulatory requirements. Utilize Kaye and Vaisala equipment for accurate and efficient validation processes. Provide technical support and troubleshooting for filling lines, lyophilizers, and biotech equipment such as bioreactors. ROLE REQUIREMENTS: To be successful in your application to this exciting role as the CQV Engineer, we are looking to identify the following on your profile and past history: Relevant degree in a scientific or engineering discipline. Proven industry experience in commissioning, qualification, and validation within the pharmaceutical sector. A working knowledge and practical experience with Kaye and Vaisala validation equipment. Key Words: CQV Engineer / Commissioning / Qualification / Validation / Autoclaves / CTUs / Depyro Tunnels / Kaye / Vaisala / Filling Lines / Lyophilizers / Biotech Equipment / Bioreactors Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career. Your next opportunity is just a click away! #J-18808-Ljbffr
