QA Validation Engineer Department: Quality Reporting to: Validation Team Lead Overview We are seeking a QA Validation Engineer to support the site validation program, ensuring compliance with regulatory, quality, and cGMP standards within a biopharmaceutical manufacturing environment. Key Responsibilities Support and execute validation activities for equipment, utilities, processes, and systems Develop and maintain: Validation Master Plan (VMP) Project validation plans and schedules Generate and execute: Validation protocols (IQ/OQ/PQ) Final reports and investigations Manage change control, deviations, and CAPA processes Review and approve validation and quality documentation Ensure all activities are completed in line with cGMP and regulatory requirements Support audits (internal and external) Contribute to continuous improvement initiatives across quality and manufacturing Maintain compliance across production areas and support cross-functional teams Requirements Degree in Engineering or a scientific discipline Minimum 3+ years experience in validation within a regulated (biopharma/pharma) environment Strong knowledge of: cGMP Validation lifecycle (IQ/OQ/PQ) Regulatory standards (FDA / EU GMP / GAMP) Excellent communication, organisation, and problem-solving skills Ability to work independently and within cross-functional teams Key Competencies Strong attention to detail with a Right First Time mindset Ability to manage multiple priorities and meet deadlines Proactive approach to issue resolution and compliance Additional Information High level of autonomy with responsibility for delivering validation activities Regular interaction with internal teams and external auditors Commitment to maintaining safety, quality, and compliance standards at all times
Project (Automation) Engineer Location: Westport Duration: 12-month initial contract (with strong extension potential) Overview We are seeking a Project (Automation) Engineer to support a large-scale Electronic Batch Record (EBR) implementation project within a pharmaceutical manufacturing environment. This role will focus on transitioning plant operations from traditional paper-based batch records to fully digital EBR systems, working as part of a cross-functional automation project team. Key Responsibilities Lead scoping and requirements definition for EBR implementation across manufacturing areas Assess equipment readiness and identify requirements for EBR conversion Define scope for: Software upgrades PLC network cards Operator interfaces (PC carts, tablets) WiFi access points, LAN infrastructure, and power requirements Develop cost estimates, including installation and potential qualification activities Prepare and present project scope, timelines, and budgets to stakeholders Raise purchase orders and coordinate with vendors and contractors Work closely with Production to plan access for installation and upgrades Act as Permit Requester, ensuring: Risk assessments Method statements EHS compliance Automation & Systems Integration Assess and scope connectivity to the Manufacturing Control Network (MCN) For networked equipment: Identify required data fields from PLC/SCADA systems Support integration into OSIsoft PI System Collaborate with Automation/OT teams to ensure data availability for MES/EBR configuration Liaise with vendors to obtain and manage PLC/SCADA data tags Project Delivery & Compliance Support engineering lifecycle documentation and system updates Participate in project reviews and technical documentation Execute engineering activities related to change control processes Ensure compliance with GMP and regulated environment standards Key Requirements Degree in Engineering (Automation, Electrical, Chemical, or related discipline) Experience in pharmaceutical or regulated manufacturing environments Strong background in: Automation systems (PLC/SCADA) MES / EBR projects (preferred) Industrial networking and system integration Proven experience in: Project engineering or project delivery Vendor and contractor coordination Costing, scheduling, and scope management Familiarity with data historians and manufacturing systems integration is an advantage Desirable Experience with EBR/MES platforms (e.g., POMS) Knowledge of validation / qualification processes (CSV) Understanding of GMP and change control systems
Quality Technician We are currently seeking a Quality Technician to join a dynamic and growing team within a highly regulated medical device manufacturing environment. This is an excellent opportunityis an initial 6-Month Contract (with view to extension) and would suit a detail-oriented professional who will contribute to quality excellence and continuous improvement initiatives. Key Responsibilities: Perform incoming, in-process, and final product inspections/testing in line with approved procedures and specifications Ensure all activities are fully compliant with cGMP, ISO, and regulatory requirements Support operations across Quality Control (QC), Incoming Quality Assurance (IQA), and Metrology areas Maintain accurate and compliant quality documentation and records Identify, report, and escalate quality issues or potential risks in a timely manner Participate in internal audits and support audit readiness activities Assist with change control processes, including documentation updates Generate and report quality metrics for management review Support batch record preparation and manufacturing documentation Make disposition decisions on incoming materials Contribute to continuous improvement initiatives across quality, safety, and production Requirements: Third-level qualification in a relevant scientific or technical discipline (desirable) 12+ years experience in a GMP-regulated environment (medical devices, pharma, or similar) Experience working within a quality system in a regulated manufacturing environment Strong understanding of GMP, ISO, and regulatory standards Key Skills & Competencies: Exceptional attention to detail and accuracy Strong problem-solving and analytical skills Ability to work independently and as part of a team Adaptable and comfortable working in a fast-paced, regulated environment Strong commitment to quality, compliance, and safety For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Senior Design Assurance Quality Engineer Role Summary The purpose of this role is to provide Design Control and Quality Engineering support for medical device products within a manufacturing environment. The position supports product development, regulatory compliance, and manufacturing quality, contributing to the successful commercialization of products and overall business growth. Key Responsibilities Design Assurance & New Product Development Act as the Quality representative and core team member on New Product Commercialization (NPC) projects. Lead and support Design Control activities, ensuring compliance with applicable regulatory and quality standards. Facilitate risk management activities, including Risk Assessments and Design Failure Mode and Effects Analysis (DFMEA). Support the development and review of product specifications, engineering drawings, and technical documentation. Process & Manufacturing Support Contribute to Process Failure Mode and Effects Analysis (PFMEA) and process validation activities for new product introduction projects. Provide quality guidance and oversight during product and process development. Quality Systems & Compliance Perform internal audits in accordance with the annual audit schedule to ensure compliance with ISO 13485 and FDA Quality System Regulations (QSR). Ensure design and development activities meet all applicable regulatory and quality requirements. Problem Solving & Continuous Improvement Support Corrective and Preventive Action (CAPA) investigations and implement effective solutions related to new product projects and manufacturing processes. Perform statistical analysis to support validation activities and continuous improvement initiatives. Training & Support Provide training and guidance to personnel on quality procedures, design controls, and regulatory requirements as required. Experience Requirements 58 years of experience in the medical device industry. Demonstrated experience with: Design Controls New Product Introduction (NPI/NPC) Statistical analysis Process validation Education & Qualifications Bachelors degree in Engineering or a related Science discipline. Professional quality qualification preferred, such as Certified Quality Engineer (CQE). Experience working in regulated environments aligned with ISO 13485 and FDA requirements.
Design Assurance Manager Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820. Ensure complete and compliant Design History Files (DHF) and design documentation. Lead risk management activities in accordance with ISO 14971. Oversee design verification and validation, including usability engineering where applicable. Support design transfer to manufacturing and related validation activities. Provide design assurance input to design changes, CAPAs, complaints, and post-market activities. Support regulatory submissions and audits (Notified Body, FDA, internal). Qualifications & Experience Bachelors degree in Engineering, Science, or related field. 5+ years experience in design assurance, quality, or regulatory roles within the medical device industry. Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls. Experience supporting audits and regulatory submissions. Key Skills Strong attention to detail and documentation skills Effective cross-functional communication Risk-based decision making Ability to work independently in a regulated environment Skills: Design assurance Quality Assurance
Engineering Technician Moulding & Assembly Key Responsibilities Support Moulding/Tooling and Assembly operations in line with safety and regulatory requirements. Ensure daily production targets are achieved in partnership with Operations Perform routine maintenance, troubleshooting, and repairs on: Injection moulding machines and tooling Automated and semi-automated assembly equipment Electrical, mechanical, and control systems Act as Subject Matter Expert for assigned equipment and processes. Perform equipment calibration and maintain maintenance/calibration systems. Interpret electrical and mechanical drawings to support fault finding and improvements. Fabricate ad hoc mechanical/electrical components for repairs and upgrades. Participate in continuous improvement and site maintenance excellence initiatives. Complete documentation, commissioning, and validation activities in compliance with cGMP. Execute all maintenance work through the Maximo management system. Support operational and strategic technical projects as required. Requirements Leaving Certificate, Senior Trade Certificate, or FETAC Level 6 (or working toward same). Minimum 3 years experience in high-precision manufacturing. Minimum 2 years experience in a regulated manufacturing environment. Experience in one or more of the following: Mould tooling Electrical systems Automation Strong problem-solving skills with complex equipment. Proficient in computer-interfaced equipment and ERP systems. For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
We are seeking an experienced and highly motivated Senior Hardware Design Engineer to join a dynamic Engineering & R&D team. This is a senior, hands-on role with a strong focus on hardware architecture and board-level design for next-generation fire and gas detection products, as well as connected IoT systems. This is an exciting opportunity to work across the full product lifecycle, from early concept development and feasibility studies through detailed design, validation, and transition into high-volume manufacturing. You will collaborate closely with firmware, software, validation, and manufacturing teams to deliver robust, compliant, and high-quality safety-critical products. About the Role As a Senior Hardware Engineer, you will play a key role in shaping next-generation products, taking ownership of complex PCB designs and driving the adoption of new technologies. You will be involved in all stages of product development from architecture definition and schematic design to layout oversight, prototype build, system bring-up, validation, and manufacturing support. This role offers strong visibility of the full product journey, with the opportunity to see your designs successfully manufactured at scale. Key Responsibilities: Define hardware architectures and deliver board-level designs for alarm, sensor, and gateway products Lead hardware development from concept through schematic capture, PCB layout support, prototype build, bring-up, and full validation Design low-power analogue and mixed-signal circuits including power management, DC-DC converters, battery charging, and battery-powered systems Develop processor-based embedded hardware platforms and digital circuit designs using microcontrollers and peripheral interfaces Integrate wireless technologies including Zigbee, Z-Wave, WiFi, and Bluetooth, ensuring strong performance and regulatory compliance Apply EMC, ESD, and EMI mitigation techniques along with RF desensitisation methods to meet global compliance standards Work closely with firmware and software teams on driver development, system integration, and system-level debugging Support product certification, regulatory compliance testing, and manufacturing ramp-up activities Ensure designs are optimised for DFM and DFT to support cost-effective, high-volume manufacturing Produce accurate technical documentation and participate in design reviews Provide mentorship and technical guidance to junior engineers where appropriate Essential Requirement: Honours degree or higher in Electronic Engineering or a related discipline Extensive industry experience in hardware design and product development Strong experience in low-power circuit design, analogue, and mixed-signal electronics Proven experience developing embedded hardware platforms and processor-based systems Demonstrated experience with schematic capture and PCB design at board level Hands-on experience with interfaces including I2C, UART, SPI, and USB Strong understanding of RF fundamentals and wireless system integration Proven experience debugging hardware designs across full product lifecycle stages Desirable Skills: Ability to work independently and make sound engineering decisions Strong communication and documentation skills Knowledge of manufacturing processes, DFM, and DFT Experience working with external manufacturing partners For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Design Assurance Manager Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820. Ensure complete and compliant Design History Files (DHF) and design documentation. Lead risk management activities in accordance with ISO 14971. Oversee design verification and validation, including usability engineering where applicable. Support design transfer to manufacturing and related validation activities. Provide design assurance input to design changes, CAPAs, complaints, and post-market activities. Support regulatory submissions and audits (Notified Body, FDA, internal). Qualifications & Experience Bachelors degree in Engineering, Science, or related field. 5+ years experience in design assurance, quality, or regulatory roles within the medical device industry. Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls. Experience supporting audits and regulatory submissions. Key Skills Strong attention to detail and documentation skills Effective cross-functional communication Risk-based decision making Ability to work independently in a regulated environment
Manufacturing Project Engineer (12-Month Contract) Location: County Cork, Ireland Company Overview: A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment. Key Responsibilities: Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes. Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems. Change Control: Oversee and support change control processes, ensuring proper documentation and approval. Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams. Documentation: Maintain clear documentation for validation, change control, and project progress. Required Skills and Experience: 3+ years of experience in medical device manufacturing, including regulatory compliance and validation. Strong knowledge of FDA, ISO 13485, and EU MDR regulations. Experience in change control processes and project task execution. Excellent attention to detail, communication, and problem-solving skills. Ability to work in a cross-functional team and manage multiple priorities. Contract Duration: 12 months, with potential for extension. Application Process: Please submit your CV and cover letter outlining relevant experience.
