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        • dublin, international
        • temporary
        • dependent on experience
        • full-time
        This is a really exciting opportunity for a motivated individual to work as a fitter for a global healthcare services company that provides customised solutions for solutions for hospitals, health systems, pharmacies and clinical laboratories worldwide. Responsibilities: Provide maintenance and technical support in a high volume manufacturing environment.Execute all maintenance work orders in line with assigned due dates.Ensure equipment breakdowns are dealt with in a timely fashion in line with business needs, and document corrective measures as required.Support ongoing Preventative Maintenance Programmes.Troubleshoot automated and manual equipment related process problems.Conduct data analysis on equipment to determine route cause.Support plant continuous improvement projects as assigned, e.g. Kaizens, Energy projects, Safety improvements, etc.Complete all purchasing transactions using approved systems such as BPCs and purchase requisitions.Organise workshop and bench in a safe, effective, and efficient manner, using the guiding principles of 5S to deliver continuous flow.Assist in the maintenance of a safe company culture by working within the company's health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures.Ensure quality in all aspects of work by following relevant Standard Operating Procedures (SOPs) and Standard Work Instructions (SWIs) and maintaining compliance with cGMP, Good Documentation Practice (GDP) and Quality Cardinal Rules.Identify continuous improvements opportunities where possible and take part in improvement projects as assigned to include by not limited to Safety or Quality related, Energy improvements, Continuous Flow improvements, etc.Complete all identified training and development activities as required including allocated ComplianceWire courses.Experience and Qualifications:Be a qualified time served Maintenance FitterMinimum of three years post apprenticeship experience in a manufacturing environment. Post apprenticeship multi-skill training would be advantageous.Competency in fabrication, welding, turning, milling, grindingExperience in Maintenance and Operations of motors, gearbox, water pumps, fans, vacuum pumps, and associated distribution pipe work.Working knowledge of electro pneumatics and hydraulic systems.The ability to work as part of a team.Good written and verbal communication skillsSelf-starter / Use of own initiative.High energy level and motivation.Excellent problem solving ability and attention to detail.Commitment to work within the ethos of the Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and the business conduct guide. Desirable criteria: Competency in electrical/ electronic systemsExperience working with CMMS maintenance systems Experience working in a regulated industry and familiarity with GMPRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
        This is a really exciting opportunity for a motivated individual to work as a fitter for a global healthcare services company that provides customised solutions for solutions for hospitals, health systems, pharmacies and clinical laboratories worldwide. Responsibilities: Provide maintenance and technical support in a high volume manufacturing environment.Execute all maintenance work orders in line with assigned due dates.Ensure equipment breakdowns are dealt with in a timely fashion in line with business needs, and document corrective measures as required.Support ongoing Preventative Maintenance Programmes.Troubleshoot automated and manual equipment related process problems.Conduct data analysis on equipment to determine route cause.Support plant continuous improvement projects as assigned, e.g. Kaizens, Energy projects, Safety improvements, etc.Complete all purchasing transactions using approved systems such as BPCs and purchase requisitions.Organise workshop and bench in a safe, effective, and efficient manner, using the guiding principles of 5S to deliver continuous flow.Assist in the maintenance of a safe company culture by working within the company's health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures.Ensure quality in all aspects of work by following relevant Standard Operating Procedures (SOPs) and Standard Work Instructions (SWIs) and maintaining compliance with cGMP, Good Documentation Practice (GDP) and Quality Cardinal Rules.Identify continuous improvements opportunities where possible and take part in improvement projects as assigned to include by not limited to Safety or Quality related, Energy improvements, Continuous Flow improvements, etc.Complete all identified training and development activities as required including allocated ComplianceWire courses.Experience and Qualifications:Be a qualified time served Maintenance FitterMinimum of three years post apprenticeship experience in a manufacturing environment. Post apprenticeship multi-skill training would be advantageous.Competency in fabrication, welding, turning, milling, grindingExperience in Maintenance and Operations of motors, gearbox, water pumps, fans, vacuum pumps, and associated distribution pipe work.Working knowledge of electro pneumatics and hydraulic systems.The ability to work as part of a team.Good written and verbal communication skillsSelf-starter / Use of own initiative.High energy level and motivation.Excellent problem solving ability and attention to detail.Commitment to work within the ethos of the Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and the business conduct guide. Desirable criteria: Competency in electrical/ electronic systemsExperience working with CMMS maintenance systems Experience working in a regulated industry and familiarity with GMPRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
        • dublin, international
        • temporary
        • dependent on experience
        • full-time
        This is a great opportunity to work for a Global pharmaceutical company and really make a difference. We are looking for an experienced pharmaceutical professional to work as a Senior Reliability Engineer in Device and Product Performance space. Responsibilities:Establishing reliability plan and specifications for emergency use products in line with FDA guidance Authoring reliability reports to support regulatory submissions Work with the device design group to build reliability into the device design from design concept Develop metrology specifications for device components using appropriate tolerance intervals and statistically justified sampling plans Liaising with manufacturing sites to ensure reliable measurement systems are in place such as metrology fixtures, functional testers and any other analytical equipment used on site.Development of design inputs and outputs based on characterization of comparator products, regulatory requirements, design intent and user requirements Ensuring adequate manufacturing controls and release activities are implemented to ensure the final Combination Product meets the reliability specifications Liaising with component and/or assembly suppliers to ensure process validation acceptance criteria is in line with overall device reliability plan Work with team to develop a Fault Tree Analysis for Combination Products to ensure all potential failure modes are identified and adequate controls are implemented to prevent occurrence Responsible for ensuring the reliability specification is translated into the product specification as part of design transfer to the commercial site Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications. Trending and statistical analysis of design verification and manufacturing data including compilation of technical reports to support combination product development lifecycle. Ensures all activities within the team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.Qualifications and experience: Qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environmentMasters/Degree in Engineering/Science with experience in a late stage R&D or Technical Support environmentPrevious experience of working as an Engineer or Scientist role in a regulated and GMP environment on combination products i.e. injectable productsExperienced in application of statistical techniques to support regulatory submission of medical devices and/or combination productsA working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantageHighly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert roleHighly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. Ability to work under pressure and have a proven track record of problem solving and effective time management.Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholdersSome travel will be required as part of this roleDue to a high volume of applications only those progressing to the next stage will be contacted. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
        This is a great opportunity to work for a Global pharmaceutical company and really make a difference. We are looking for an experienced pharmaceutical professional to work as a Senior Reliability Engineer in Device and Product Performance space. Responsibilities:Establishing reliability plan and specifications for emergency use products in line with FDA guidance Authoring reliability reports to support regulatory submissions Work with the device design group to build reliability into the device design from design concept Develop metrology specifications for device components using appropriate tolerance intervals and statistically justified sampling plans Liaising with manufacturing sites to ensure reliable measurement systems are in place such as metrology fixtures, functional testers and any other analytical equipment used on site.Development of design inputs and outputs based on characterization of comparator products, regulatory requirements, design intent and user requirements Ensuring adequate manufacturing controls and release activities are implemented to ensure the final Combination Product meets the reliability specifications Liaising with component and/or assembly suppliers to ensure process validation acceptance criteria is in line with overall device reliability plan Work with team to develop a Fault Tree Analysis for Combination Products to ensure all potential failure modes are identified and adequate controls are implemented to prevent occurrence Responsible for ensuring the reliability specification is translated into the product specification as part of design transfer to the commercial site Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications. Trending and statistical analysis of design verification and manufacturing data including compilation of technical reports to support combination product development lifecycle. Ensures all activities within the team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.Qualifications and experience: Qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environmentMasters/Degree in Engineering/Science with experience in a late stage R&D or Technical Support environmentPrevious experience of working as an Engineer or Scientist role in a regulated and GMP environment on combination products i.e. injectable productsExperienced in application of statistical techniques to support regulatory submission of medical devices and/or combination productsA working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantageHighly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert roleHighly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. Ability to work under pressure and have a proven track record of problem solving and effective time management.Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholdersSome travel will be required as part of this roleDue to a high volume of applications only those progressing to the next stage will be contacted. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003

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