Job Title: Validation Engineer Location: Galway Status: Permanent Position Summary: This is an exciting opportunity to contribute to a growing, collaborative environment where your expertise helps drive operational excellence and regulatory compliance. Reporting to the Validation Team Lead, youll help implement the Validation Master Plan, maintain SOPs, execute validation activities across processes, cleaning, equipment, analytical instruments and utilities. Key Responsibilities: Maintain accurate, audit-ready validation documentation in line with SOPs and regulatory requirements Ensure all validation activities comply with GMP, regulatory guidelines, and internal procedures. Collaborate closely with manufacturing, quality, engineering, and analytical teams to coordinate validation activities. Support technology transfers and new product introductions through effective validation planning and execution. Qualifications and Requirements: Strong knowledge of GMP and validation principles. 2+ years experience in validation within a GMP-regulated environment Ability to maintain audit-ready records and ensure accuracy and completeness in validation documentation. Degree in Engineering, Pharmaceutical Science, or a related discipline For a confidential conversation about the position contact Karl on or By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Job Title: Validation Team Lead Location: Galway Status: Permanent Position Summary: This is an exciting opportunity to shape validation excellence in a growing, high-performing environment. Were looking for a dynamic Validation Team Lead to take ownership of our sites validation strategy and ensure full compliance with regulatory and company standards. In this key leadership role, youll guide the Validation function, manage the Validation Master Plan and oversee critical validation activities across processes, cleaning, equipment, analytical instruments and utilities. Key Responsibilities: Oversee process validation for both new and existing products, including protocol development and execution. Manage cleaning validation programs to safeguard product integrity and mitigate cross-contamination risks. Lead, mentor, and develop the Validation team to drive strong performance and engagement. Prioritise and allocate resources effectively to meet business goals and compliance requirements. Ensure timely completion and approval of validation protocols, reports, and documentation. Provide validation support for technology transfers and new product introductions. Qualifications and Requirements: Deep understanding of GMP and relevant regulatory requirements. Strong leadership, communication, and organisational skills. Hands-on experience across process, cleaning, equipment, and utilities validation A commitment to excellence in compliance and documentation. For a confidential conversation about the position contact Karl on or By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Finance Business Partner (Cost Accounting) We are seeking a Finance Business Partner (Cost Accounting) to lead the management accounting function and provide critical financial insights that drive operational efficiency and profitability within a fast-paced manufacturing environment. In this senior role, you will partner closely with Production, Supply Chain, Finance, and cross-functional teams to ensure accurate cost information, effective cost control, and continuous improvement across the organisation. Key Responsibilities; Management Accounting Oversee all cost accounting activities, including standard costing, inventory valuation, and cost variance analysis. Maintain and enhance cost accounting systems to ensure accurate and timely reporting. Prepare monthly, quarterly, and annual cost reports for leadership review. Cost Analysis & Reporting Analyse production costs, overheads, and key cost drivers. Deliver insights on cost trends, product profitability, and operational performance. Develop and monitor KPIs focused on cost management and operational efficiency. Conduct variance analysis and present findings with actionable recommendations. Work collaboratively with department heads to monitor and manage cost performance. Process Improvement Identify opportunities for cost reduction, process optimisation, and improved data accuracy. Lead initiatives to automate and streamline cost accounting and reporting workflows. Partner with IT and Finance on system enhancements and efficiency projects. Team Leadership Lead, mentor, and develop a high-performing cost accounting team. Foster a culture of accountability, collaboration, and continuous improvement. Drive cross-functional efforts to support company-wide cost optimisation initiatives. Additional Responsibilities Support annual budgets, rolling forecasts, and long-term financial planning. Ensure accurate inventory valuation, including standard and actual cost of goods sold. Education & Experience Bachelors degree in Accounting or Finance. Professional accounting qualification (ACA/CPA, CIMA, ACCA). 5+ years' experience in cost accounting or financial analysis, ideally in a GMP manufacturing or production environment. Strong understanding of standard costing, activity-based costing, and variance analysis. Proficiency with ERP systems (e.g., SAP, Oracle). Skills & Competencies Advanced Excel and strong data analysis skills. Excellent analytical, communication, and problem-solving capabilities. High attention to detail with the ability to meet tight deadlines. Strategic thinker with the ability to turn data into actionable insight. Strong leadership and team management skills. Proven ability to work effectively with cross-functional teams. 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.
About the Role We are seeking an experienced Operations Aseptic Specialist to join our Aseptic Manufacturing team. The successful candidate will serve as a Subject Matter Expert (SME) in aseptic operations, ensuring compliance with regulatory requirements and best practices, driving continuous improvement, and supporting the delivery of sterile products of the highest quality. Key Responsibilities Serve as a site Subject Matter Expert in Aseptic Manufacturing. Provide guidance and input for manufacturing process setup and batch records. Ensure operational procedures comply with regulatory requirements, safety, environmental regulations, GMP standards, and aseptic best practices. Utilize risk management tools (pFMEA, HAZOP, What-If analyses) to drive aseptic performance and sterility assurance. Collaborate with Quality, Engineering, and Aseptic teams to support manufacturing shifts and ensure safe, timely, and sterile batch production. Observe and provide feedback on aseptic technique and behaviors during critical activities such as cleaning, sanitization, aseptic setup, EM plate handling, and interventions. Lead and support investigations into process or product issues related to sterility, media fills, environmental monitoring excursions, and EMPQ, contributing to root cause analysis and CAPA. Analyze and trend environmental monitoring (EM) data, maintaining EM visualization tools and implementing action plans to address trends. Contribute to the continuous improvement of aseptic procedures and processes by interpreting and applying new regulatory requirements, developing best practices, and supporting site change control processes. Provide input on contamination control strategy, aseptic process simulation (APS) strategy, long-range planning related to aseptic manufacturing, and cleanroom/equipment design, qualification, and maintenance. Support regulatory audits as a subject matter expert in aseptic manufacturing and sterility assurance. Train operations personnel in aseptic techniques and aseptic processing procedures. Participate in leadership GEMBAs of manufacturing and testing areas to drive performance and engagement. Qualifications & Experience Third-level degree in Science, Quality, or Engineering discipline. Minimum 5 years of experience in a GMP environment, with at least 3 years supporting aseptic manufacturing (non-negotiable). Strong knowledge of regulatory requirements, including EU GMP Annex 1, FDA 21 CFR Parts 210, 211, and 610, and relevant guidance documents. Expertise in risk management tools that drive aseptic performance, including contamination control strategies, pFMEA, HAZOP, and What-If analyses. Experience in tracking, analyzing, and trending environmental monitoring data. Proven experience in investigations related to sterility, media fills, EM excursions, and EMPQ, with ability to determine root cause and drive CAPA. Excellent communication and interpersonal skills with a focus on collaboration and leadership. 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.
Job Summary: The Production Supervisor will oversee manufacturing operations in a medical device environment, ensuring efficient production, compliance with regulatory standards, and adherence to quality and safety protocols. The role involves leading a team, optimizing workflows, and driving continuous improvement initiatives. Key Responsibilities: Supervise daily production activities to meet output, quality, and efficiency targets. Ensure compliance with medical device regulations (FDA, ISO 13485, GMP). Train, mentor, and manage production staff to enhance team performance. Monitor and enforce safety protocols to maintain a safe working environment. Collaborate with engineering, quality, and supply chain teams to resolve production issues. Implement lean manufacturing and continuous improvement initiatives. Maintain accurate documentation and reporting for audits and compliance. Troubleshoot and resolve equipment or process inefficiencies. Support new product introductions and scale-up manufacturing processes. Required Qualifications & Skills: Bachelors degree in Engineering, Manufacturing, or related field, or equivalent experience. 3+ years of supervisory experience in a medical device or regulated manufacturing environment. Strong knowledge of GMP, FDA regulations, and ISO 13485 requirements. Excellent leadership and team management skills. Experience with lean manufacturing and process optimization. Strong problem-solving and decision-making abilities. Effective communication and interpersonal skills. Preferred Qualifications: Six Sigma or Lean Manufacturing certification. Experience with ERP/MES systems in a manufacturing setting. Familiarity with validation and process improvement methodologies. Work Environment: Manufacturing floor and office-based work. Requires standing for extended periods and working in a controlled environment. Occasional evening or weekend shifts may be required. 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.
Job Title: CNC Programmer Location: Limerick Status: Permanent Position Summary: The role of CNC Programmer involves programming, setting up, and operating CNC and Swiss-type sliding head machines. Strong hands-on expertise with Swiss-type machines, and proficiency in CNC, 5-axis, and mill-turn programming. The company offers a cutting-edge R&D environment, career development opportunities and an entrepreneurial, team-focused culture Key Responsibilities: Collaborate on process development for new and complex components, working closely with engineering teams. Optimise CNC programs and processes to achieve production efficiency while maintaining the highest quality standards Take ownership of projects, ensuring production goals are met and maintaining strong client satisfaction. Qualifications and Requirements: Experience in programming machines essential 5 years experience in a similar CNC Operator type role. Experience in 5 axis programming andmillturn programming For a confidential conversation about the role contact Karl on or By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Overview We are seeking an experienced Additive Manufacturing Lead to oversee Laser Powder Bed Fusion (L-PBF) capabilities and drive the successful launch of new additive manufacturing projects from development through high-volume production. This role is ideal for someone with strong technical expertise, a passion for advanced manufacturing technologies, and the ability to thrive in a fast-paced, dynamic environment. Key Responsibilities Act as the technical owner of all Laser Powder Bed Fusion (L-PBF) operations. Lead Additive Manufacturingfocused New Product Introduction (NPI) projects. Ensure compliance with Health & Safety standards within the additive manufacturing area. Manage preventative maintenance scheduling to ensure equipment uptime and reliability. Develop and oversee production schedules to meet business and customer requirements. Create and execute long-term strategies for scaling to higher-volume AM production. Lead process validation activitiesincluding VP, IQ, OQ, PQand maintain all required documentation. Participate in cross-functional project meetings and timeline reviews. Train and mentor manufacturing team members on AM processes and best practices. Collaborate with Materials Science, Design Engineering, Quality Assurance, and other departments to deliver high-quality products on schedule. Perform additional duties as required to support operational goals. Qualifications & Experience Bachelors degree in Industrial Engineering, Mechanical Engineering, or a related discipline. Engineering experience within the medical device industry. Hands-on experience with Laser Powder Bed Fusion additive manufacturing. Knowledge of Lean methodologies (Six Sigma, Kaizen, Kanban, 5S). Strong understanding of operations and New Product Introduction (NPI) processes. Excellent verbal and written communication skills for working with internal and external stakeholders. Self-starter with strong analytical, problem-solving, and multitasking abilities. Ability to excel in a dynamic, results-driven, and collaborative environment. Demonstrated success in cross-functional teamwork, particularly with Product Development and Quality teams. 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.
Validation Engineer Reporting To: NPI & Engineering Manager Overview We are seeking an experienced engineer with advanced expertise in metrology and validation to support upcoming New Product Introduction (NPI) projects and the new building expansion. The successful candidate will play a key role in ensuring product and process compliance, supporting facility readiness, and driving continuous improvement in a regulated environment Key Responsibilities Validation Develop and execute comprehensive validation protocols (IQ/OQ/PQ) for equipment, processes, and products, ensuring compliance with industry standards (e.g., ISO 13485, FDA). Lead and document validation activities for new product launches, process changes, and facility expansions. Collaborate with cross-functional teams (engineering, quality, manufacturing, regulatory) to ensure validation deliverables are met on time and within scope. NPI Project Support Act as a technical expert in metrology and validation during NPI project phases, supporting prototype builds, pilot runs, and full-scale production launches. Participate in risk assessments (FMEA), process mapping, and control plan development for new products. Ensure facility readiness by coordinating equipment qualification, process validation, and documentation with relevant stakeholders. Documentation & Compliance Maintain accurate and thorough documentation aligned with regulatory, quality, and company standards. Prepare validation reports, inspection records, and change control documentation for audits and regulatory submissions. Support internal and external audits, including responding to audit observations and implementing corrective actions. Continuous Improvement Identify and lead process improvement initiatives related to metrology, validation, and NPI activities. Provide training and mentorship to junior engineers and technicians on metrology and validation best practices. Stay current with emerging technologies, regulatory changes, and industry trends to enhance department capabilities. Qualifications & Experience Bachelors or Masters dree in Engineering (Mechanical, Biomedical, or related discipline). Proven experience in metrology techniques and tools (CMM, gauges, calibration). Hands-on experience with validation activities (IQ/OQ/PQ) in a regulated environment (medical device, pharma, or similar). Strong problem-solving, analytical, and communication skills. Experience with quality management systems (ISO 13485, FDA) and regulatory audits. Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously. Experience with risk management (FMEA), process mapping, and statistical analysis is highly desirable. Flexibility and adaptability to support dynamic project requirements and timelines.
Senior Mechanical Engineer Galway Overview A leading provider of materials handling and advanced automation solutions is seeking a highly skilled Senior Mechanical Engineer to drive the design, development, and delivery of innovative mechanical systems within turnkey automation projects. The ideal candidate will bring strong technical expertise, exceptional problem-solving ability, and a commitment to engineering excellence. Key Responsibilities Lead the mechanical design of automated machinery, materials handling equipment, and custom-engineered solutions. Produce high-quality 3D models, detailed manufacturing drawings, and technical documentation. Perform engineering calculations, tolerance analysis, material selection, and design validation. Collaborate with electrical, controls, manufacturing, and project management teams to ensure successful project execution. Support concept development, feasibility studies, and cost estimation for new opportunities. Provide technical leadership and mentorship to junior engineers and designers. Conduct design reviews, risk assessments, and ensure compliance with relevant standards and safety regulations. Engage with suppliers and fabrication partners to optimize manufacturability and quality. Support equipment installation, commissioning, and troubleshooting when required. Drive continuous improvement of engineering processes, tools, and best practices. Required Skills & Experience Bachelors degree in Mechanical Engineering (Masters preferred). 7+ years of mechanical design experience within automation, machinery, materials handling, robotics, or related fields. Expert proficiency with CAD software (e.g., SolidWorks, Inventor, or equivalent). Strong understanding of mechanical systems, kinematics, pneumatics, hydraulics, and structural design. Proven ability to lead design projects from concept through completion. Experience with manufacturing processes such as machining, fabrication, and assembly. Excellent analytical, problem-solving, and communication skills. Ability to manage multiple projects in a fast-paced environment. Desirable Qualifications Experience with automation integration and motion systems. Knowledge of FEA, simulation tools, and optimization techniques. Familiarity with CE/UL standards and machinery safety regulations. Hands-on involvement with on-site installation or commissioning. Project management experience or relevant certification.
Role Overview The successful candidate will be responsible for designing, coding, and testing DeltaV software modifications across all stages of the project lifecycle. This includes working with a range of automation systems such as PLCs, DCS platforms, and related technologies. You will contribute to the development and execution of automation strategies and participate in design reviews, commissioning activities, and validation processes to ensure high-quality project delivery. Key Responsibilities Design, implement, and test DeltaV software changes in alignment with project requirements. Support and integrate additional automation systems including PLCs, DCS platforms, historians, and MES systems. Participate in technical strategy development for automated project execution. Perform detailed reviews throughout design, commissioning, and validation phases. Collaborate with cross-functional teams and stakeholders at various organizational levels. Troubleshoot, problem-solve, and support automation systems throughout the project lifecycle. Work independently and remotely with minimal supervision while maintaining strong customer relationships. Required Skills & Experience Significant, hands-on experience with Emerson DeltaV Distributed Control Systems. Strong knowledge of batch processing and familiarity with S88 standards. Ideally trained through Emersons in-house DeltaV training program. Minimum of 5 years experience in automation systems administration with expertise in one or more of the following: Rockwell FactoryTalk DCS platforms OSI PI Historian Syncade Siemens systems Proven communication, collaboration, and organizational skills. Strong critical-thinking and customer-relationship management skills. Demonstrated project management and problem-solving capabilities. Candidate Profile Bachelors degree (B.Sc.) in Engineering or equivalent discipline, ideally in software development, electrical, electronic, or automation engineering. Minimum 5 years of industry experience, preferably in pharmaceutical, biotechnology, blue-chip, or other GMP-regulated manufacturing environments. Excellent communication abilities and strong technical problem-solving skills. Candidates with formal Emerson DeltaV training through the dedicated training center will be given preference. 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.
