Real Staffing Group

PCS7 SIS Functional Safety Engineer Location: Remote (with some visits to client sites) Contract Type: 12-Month Initial Contract, Outside IR35 Rate: To quote Real Staffing are seeking a highly skilled PCS7 SIS Functional Safety Engineer to join our team on a 12-month initial contract basis, with the potential for extension. Role Overview: As a PCS7 SIS Functional Safety Engineer, you will be instrumental in ensuring the safety and reliability of our clients' systems. Your expertise in designing, implementing, and maintaining Safety Instrumented Systems (PCS7 SIS). This is a remote role with some visits to client sites as required. Key Responsibilities: Design, develop, and implement Safety Instrumented Systems (PCS7 SIS) for various projects in the process and life science industries. Conduct Functional Safety Assessments and ensure compliance with relevant safety standards and regulations. Perform safety analysis, including HAZOP, LOPA, and SIL determination. Collaborate with clients, project managers, and multidisciplinary teams to develop and execute safety strategies. Provide technical support and guidance throughout the project life cycle, from conception to commissioning. Conduct safety audits, inspections, and assessments to ensure the integrity and reliability of SIS. Develop and maintain safety documentation, including Safety Requirements Specifications (SRS), Safety Validation Plans (SVP), and Safety Integrity Level (SIL) verification reports. Stay updated with industry trends, best practices, and regulatory changes related to functional safety. Qualifications: TUV Functional Safety Certification is mandatory. Proven experience in designing and implementing SIS using Siemens PCS7. In-depth knowledge of functional safety standards (IEC 61508, IEC 61511) and safety life cycle management. Ability to work independently and collaboratively within a team. Willingness to travel occasionally to client sites as required. How to Apply: If you are a dedicated and TUV Functional Safety certified professional with PCS7 we would love to hear from you. Please submit your CV and we will be in touch to discuss further. Please visit our website to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement. To find out more about Real, please visit our website Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales

We're looking for a Senior Regulatory Affairs Specialist for a fast growing med tech company based Cork (Ireland). The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. This position offers an excellent compensation package and potentially hybrid working. Responsibilities Regulatory Strategy Development: Formulate and execute strategies for product registration, approval, and compliance Daily Regulatory Management: Oversee day-to-day regulatory activities and manage multiple projects related to regulatory compliance Submission Management: Prepare, maintain, review, and submit regulatory documents and applications to health authorities Global Registration Support: Assist the team in obtaining and retaining country-specific regulatory registrations worldwide MDSAP Implementation: Manage the implementation of the Medical Device Single Audit Program within the organization Regulatory Compliance Monitoring: Ensure compliance with national and international regulatory requirements and quality standards Risk Assessment: Identify and assess potential regulatory risks and propose effective mitigation strategies Cross-Functional Collaboration: Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes Regulatory Updates: Stay current with changing regulations, guidelines, and industry trends Maintain high-quality standards within the organization by assessing risk profiles and creating mitigation programs/tools. Post Market Surveillance: Manage activities including logging customer complaints and adverse events, coordinating investigations, and conducting regulatory trending and reporting CE Mark Submissions: Handle submissions, significant change notifications, and interactions with Notified Bodies International Filings: Support the team with the preparation of international regulatory filings, including 510(k) submissions and FDA correspondence Material Review: Ensure public-facing materials comply with regulatory standards Skills and Qualifications Bachelor's degree in Engineering or Science or practical expertise Regulatory experience in the medical device industry Understanding of ISO 13485, ISO 14971, EU MDR, UK, MDSAP, 21 CFR 820, and supporting standards Please visit our website to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement. To find out more about Real, please visit our website Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales

Automation Engineer - Contract Position in Dublin We are currently seeking an experienced Automation Engineer based in Dublin, Ireland. This position is ideal for someone with a mid-Senior level experience within GMP/Pharma/Biotech manufacuring that is looking for an interesting and varied role that includes working on ongoing Operations, Capital and Strategic projects. Key Responsibilities: System Oversight: Manage and oversee automation systems to ensure optimal uptime and performance. Access Management: Handle system user access, backups, and restores efficiently. Corrective Actions: Implement corrective measures and collaborate with vendor technical support to resolve issues. Project Execution: Identify, plan, and execute small projects aimed at enhancing system performance. Capital Planning: Contribute to capital planning, project execution, and meticulous documentation. Compliance: Ensure all activities comply with site and corporate Quality Systems. Deliverables: Create and maintain engineering deliverables and test scripts. Global Strategies: Develop and implement global automation strategies to standardize processes across the board. System Optimization: Maintain and optimize automation systems and infrastructure. Tailored Solutions: Develop solutions that are specifically tailored to our manufacturing environment. Project Management: Drive automation projects, ensuring that cost, schedule, and technical goals are met. Tech Trends: Stay updated with technology trends and benchmarks to keep the company at the forefront of innovation. Experience: Minimum of 5 years of work experience in GMP manufacturing with a strong expertise in automation. A broad understanding of pharmaceutical manufacturing processes and regulatory environments is essential. Experience in the pharmaceutical industry is advantageous. Technical Proficiency: Proficiency in automation solutions (Siemens, Omron, Mitsubishi, etc.) and knowledge of industry standards (GAMP, ANSI/ISA, 21 CFR Part 11, Annex 11). Familiarity with ANSI/ISA-99,100 standards is a plus. Please visit our website to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement. To find out more about Real, please visit our website Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales

A global medical device company are looking for a Senior Test Engineer to join their R&D and Process Development teams on a contract basis. Your role will be to help build R&D test systems from the ground up. For the work that doesn't need to be done from scratch, some of the work will have been started already, you will need to take it to the next level. You will also be updating the R&D test systems from a LabView test requirement. There is an expectation of 2-3 days on-site per week, the rest of the work can be done remotely. Initially you will need to come onsite to meet the team and understand what is required for the project. This will give you insight into what the current test system is doing, you will be able to discuss with the other engineers there and then you can cycle through the processes to push out improvements and updates. These test systems will need to be built up and developed with additional capabilities to be added too. Essential skills: Controlling equipment using LabView Test and duration experience Demonstrated capability in LabView Desirable: Use of software languages: MATLAB (Python & C++) The start date is for ASAP. The initial contract length is for 12 months, with multiple extension options after. The role is based in County Tipperary and will require 2-3 days onsite per week minimum, the rest of the time you can work remotely. The rate is between €55-70 per hour, depending on experience, if you have any expenses please let me know and I can factor that into the rate for you. If you are interested in the role, please send me your latest CV and I will call you to discuss the further details. Please visit our website to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement. To find out more about Real, please visit Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales