A Sterilisation Validation Engineer is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime on-site role on an initial 17-month contract. The Sterilisation Validation Engineer will support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites. The Role Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation. Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Requirements Bachelor’s Degree (Level 8) in a relevant Science Engineering or other technical discipline. 1-2+ years’ experience in a GMP environment. Experience in Sterility Assurance or Microbiology ( Endotoxin, Bioburden etc) would be of interest. #J-18808-Ljbffr
CareerWise Recruitment is partnering with a prominent Galway-based company to recruit a dynamic Contract Road Project Manager for the Clare, Kerry and the Cork Region. The Project Manager is responsible for planning, coordinating, and delivering all site operations within their area of responsibility. This includes ensuring that works are completed safely, efficiently, and in full compliance with specifications, quality standards, and client requirements. The role also carries responsibility for the financial performance of contracts, while building and maintaining strong customer relationships is a key priority. Act as Project Supervisor Construction Stage in accordance with the Safety, Health and Welfare at Work (Construction) Regulations 2013 Prepare Construction Stage Health & Safety Plans based on client-issued preliminary plans. Conduct regular audits and inspections of Temporary Traffic Management. Ensure all supervisors and foremen communicate Site Inductions, Method Statements, and Safe Systems of Work to employees, contractors, visitors, and suppliers. Manage the contractor programme, ensure all reporting obligations are met, and attend required meetings with the Employer’s Representative Liaise effectively with the Employer’s Representative and fulfil all duties outlined in the Works Requirements. Carry out site safety audits in line with company procedures Collaborate with internal teams (HR, Safety, Environmental, etc.) to ensure activities are carried out correctly and compliantly. At least 3 years’ plus experience in the delivery and management of sign installation works on high-speed national roads, including contract management responsibilities. Relevant technical qualifications with strong, detailed knowledge of the Traffic Signs Manual, Dashboard Manual, Health & Safety regulations, and the mechanical aspects of road signage. A recognised Health & Safety certification relevant to construction or roadworks environments. Practical working knowledge of legislation and regulations relating to Health & Safety, Site Operations, Traffic Management, Quality standards, Financial controls, and Group Compliance requirements. #J-18808-Ljbffr
Senior Process Development Engineer We are seeking a Senior Process Development Engineer for a multinational medical device client in Galway for an initial 18-month contract, on site. Responsibilities Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. Qualifications Degree L8 in Engineering/Science or a related discipline. Minimum 5+ years in the medical device industry. Knowledge of medical device processes with a good understanding of product and process design/characterisation. #J-18808-Ljbffr
CareerWise Recruitment is seeking a Senior Process Development Engineer for a multinational medical device client in Galway. This role, requiring a degree in Engineering/Science and a minimum of 5 years' experience in the medical device industry, involves providing technical support, implementing process modifications, and ensuring design compatibility. The position is on-site for an initial 18-month contract, offering an opportunity to influence quality standards and production efficiencies. #J-18808-Ljbffr
Regulatory Affairs Officer Our client who is a leading pharmaceutical company baesd in Waterford is looking for a Regulatory Affairs Specialist for a 9-month contract. If you have experience in regulatory affairs in the pharmaceutical or biopharmaceutical industry then this is the job for you !! This is a hybrid position with 3 days on site and 2 days working from home The Role Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs). Assess the regulatory impact of proposed changes by site for assigned products. Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate. Second RSO review for submission documentation. Track all site regulatory activities in real time within the site planning tracking tools. Monitor submission/approval status and track updates for assigned products. Participate in regulatory inspections/audits. Initial BLA/MAA authoring/coordination, as appropriate. Product Registration Renewals. Annual Reports e.g. US, Canada, Brazil. Periodic Quality Reviews (PQR). Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalisations and notarisation requests. Preparation of Site Master File (SMF). Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification. Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR). Requirements Degree in Science, Pharmacy or related discipline is essential. Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable 2-5 years experience within the pharmaceutical or biopharmaceutical background. Please call Louise Mulligan today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Regulatory Affairs Specialist Regulatory Compliance Benefits: Work From Home
A Senior Analog IC Design Engineer is needed by CareerWise Recruitment for our Cork based global electronics client. The successful candidate will work on the design of ICs for next generation optoelectronic modules for systems used in renewable energy, consumer, industrial and medical applications worldwide. THE ROLE: Design receiver ICs for optoelectronic applications. Design LED and laser driver ICs. Carry out layout of critical analog block and supervision of IC Layout engineers. Contribute to IC characterisation, test, and qualification engineering activities. Work closely with production engineering teams to successfully release products to manufacturing. REQUIREMENTS: Bachelors degree or higher in electrical engineering, telecommunications engineering, or a related field. 5-10 years of analog IC design experience. Understanding of the fabrication process and its impact on circuit behaviour. Ability to create innovative and novel circuits. Knowledge of design tools such as Cadence or Mentor Graphics Must have previous full product development experience to tape-out and production. Please call Ken Murphy today for further information on or email: CareerWise Recruitment (In Search of Excellence) N.B. It is essential that you hold a valid working visa for Ireland Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Senior Analog IC
Careerwise is partnering with a leading pharmaceutical client to hire an Associate Director Bioassay QC Lead for a pharmaceutical company based in Louth. This is your chance to step into a high-impact leadership role where you’ll drive quality excellence, lead a strong QC team, and play a key part in delivering vaccine products that make a real difference globally !!! THE ROLE Develop and lead a world-class Bioassay team QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities. Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment. Prepare, review, and approve technical documents such as method protocols and validation reports. Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities. Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs. Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency. Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs. Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures. REQUIREMENTS BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field. Strong understanding of analytical an Minimum of 5- 8 years of vaccine industry experience preferred, or minimum 5 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing. Experience with vaccines/viral testing and biosafety clouthgontainment levels, preferably BSL-3. Proven track record working cross-functionally across a wide variety of technical, business, and operational areas. Required Skills: Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology Preferred Skills: Biosafety, Vaccine Safety. Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. #J-18808-Ljbffr
CareerWise Recruitment is seeking a Design and Development Engineer for a multinational medical device client in Galway. This role involves new product development, process design, and collaboration with cross-functional teams. The ideal candidate will have a degree in Engineering or Science and a minimum of 2 years in the medical device industry. This position offers an on-site working arrangement on an initial 12-month contract, emphasizing innovation and quality improvement in process technology. #J-18808-Ljbffr
Overview A Design and Development Engineer is required by CareerWise Recruitment for our multinational medical device client in Galway for an initial 12-month contract, on site role. The Design and Development Engineer will actively participate in all areas of new product development including the following: Process design, Process characterisation, Technology development & advancement, Automation, Vendor, Sub Tier supplier management & Project management. The Role Collaborate with cross functional teams to define, execute and deliver on requirements in the Pre and Post market space. Lead and support the process development, process characterisation, and process validation activities to support new product introduction. Take initiative & lead, innovate and develop process technology with emphasis on improving quality, reducing variation and developing state of the art automated and semi-automated systems. Identify and mitigate technology and process risks through the design process. Collaborate with team members on Design, Reliability & Manufacturability methodology (DRM), utilise 3-D drawing/printing and Augmented Reality to develop our best solutions. Requirements Degree L8 in Engineering/Science or a related discipline. Minimum 2+ years in the medical device industry. Knowledge of medical device processes with a good understanding of product and process design/characterisation. #J-18808-Ljbffr
CareerWise Recruitment is seeking an Associate Director Bioassay QC Lead for a pharmaceutical company in Louth, Ireland. In this high-impact role, you will lead a quality control team ensuring GMP compliance in vaccine production. Candidates should possess a BSc or MSc in a relevant scientific field and have 5 to 8 years of industry experience. Responsibilities include method development, technical document approval, and quality oversight during regulatory inspections. Strong leadership and analytical skills are essential. #J-18808-Ljbffr
