Job Description Summary The Systems QA Specialist provides Quality System (QMS) support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment. The role focuses on strengthening and maintaining compliant quality systems that enable safe, effective, and timely product supply. Working cross-functionally with Manufacturing, Engineering, Validation, QC Microbiology/QC Labs, and Supply Chain, the Systems QA Specialist supports site performance through robust documentation, change control, deviation/CAPA management, risk management, and inspection readiness. Job Description Responsibilities 1) QMS Management & System Oversight (Primary Focus) Support end-to-end execution of core QMS processes within assigned areas: Deviations/Nonconformances, CAPA, Change Control, Risk Assessments, Document Control, and Training Compliance. Ensure QMS records are initiated, assessed, progressed, and closed within SLA and meet data integrity and GDP expectations. Support routine system health activities: periodic reviews, metrics/KPIs, trending, and continuous improvement actions. Maintain and support inspection readiness through strong system discipline, clear traceability, and effective evidence packs. 2) Change Control & Technical Quality Support (Sterile Systems) Support and/or coordinate change controls affecting sterile operations, terminal sterilisation processes, equipment, utilities, and supporting systems. Ensure changes are risk assessed (e.g., product impact, sterility assurance impact), appropriately documented, and aligned with validation/qualification requirements. Partner with Engineering/Validation to ensure implementation readiness: SOP updates, training completion, validation documentation, and effective handover to operations. 3) Deviation Investigation & CAPA Support Support investigations for process, equipment, utilities, documentation, and microbiology/EM-related events, ensuring structured root cause analysis. Drive high-quality problem statements, impact assessments, containment actions, and timely CAPA development. Support CAPA effectiveness checks and ensure learnings are embedded to prevent recurrence. 4) Terminal Sterilisation & Sterility Assurance Systems Support Provide QA system support for terminal sterilisation lifecycle activities, including: Sterilisation cycle documentation control and review support (as per site procedures) Change management and validation alignment for steriliser cycles, load patterns, and critical parameters Support for sterility assurance risk assessments and periodic reviews Interface with QC Microbiology for system-level trending and governance of sterility assurance metrics (e.g., EM trends, excursions, recurring themes). 5) Documentation & Training Compliance Author, review, and/or approve controlled documents (SOPs, WIs, forms, templates) supporting sterile operations and terminal sterilisation systems. Ensure training requirements are defined and tracked; support training effectiveness where required. Promote Good Documentation Practices (GDP), right-first-time behaviours, and consistent use of approved templates. 6) Audit & Inspection Support Support internal audits, supplier quality interfaces (as applicable), and regulatory/customer inspections: Prepare evidence packs and system narratives Support responses to observations and timely closure of actions Ensure records are inspection-ready with strong traceability and rationale 7) Continuous Improvement Identify opportunities to streamline QMS workflows while maintaining compliance (e.g., standardised investigation templates, improved change control quality, trending dashboards). Support site quality initiatives impacting sterile systems performance (e.g., CCS alignment, aseptic governance, documentation simplification). Required Qualifications Bachelor's degree (or equivalent experience) in Science, Engineering, Pharmacy, or related discipline. Experience in GMP Quality Assurance or Quality Systems within sterile/aseptic manufacturing or similarly regulated environments. Hands-on experience supporting QMS processes: deviations, CAPA, change control, documentation (and ideally risk management). Strong understanding of GDP and data integrity expectations. Effective communication skills and ability to collaborate across functions. Key Competencies Strong systems thinking and attention to detail; able to maintain compliant documentation and traceability. Structured problem solving and root cause analysis capability. Ability to manage priorities and timelines; confident in escalation when risks are identified. Collaborative mindset with the ability to influence quality outcomes without direct authority. Consistent focus on patient safety, product quality, and compliance. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. Total Rewards Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-onsite #LI-BG1 Additional Information Relocation Assistance Provided: No To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
GE HealthCare recrute un(e) Directeur(trice) Senior des Affaires Réglementaires pour diriger les stratégies réglementaires pour le portefeuille Pharmaceutical Diagnostics. Le candidat idéal aura plus de 7 ans d'expérience en affaires réglementaires, avec une expertise en gestion de cycle de vie et en interactions avec les agences réglementaires. Le poste est basé à Cork, en Irlande, et implique de travailler en étroite collaboration avec des équipes globales pour assurer la conformité réglementaire. Aucune assistance à la relocalisation n'est fournie. #J-18808-Ljbffr
Job Description Summary Il s’agit d’un poste de Directeur(trice) Senior. Le/La Directeur(trice) Senior, Affaires Réglementaires – UE Direct et Canada assure un leadership réglementaire stratégique et opérationnel de haut niveau pour le portefeuille Pharmaceutical Diagnostics (PDx) de GE HealthCare dans la région. This is a Sr. director’s role. The Sr. director, Regulatory Affairs – EU Direct and Canada provides senior strategic and operational regulatory leadership for GE HealthCare’s Pharmaceutical Diagnostics (PDx) portfolio across the region. The role is accountable for defining and executing regulatory strategies in the region, specifically for products in development seeking initial registration, as well as for legacy and marketed products pursuing new indications, lifecycle maintenance and extensions, or expansion into additional markets in the region. This position ensures regulatory continuity, compliance, and support of PDx growth objectives. Key Responsibilities Define, lead and oversee the regulatory strategy in the region across the product lifecycle, including development, registration, and post‑approval activities, in alignment with EMA, CMDh, national competent authority requirements and Health Canada. Apply strategic regulatory thinking to anticipate regulatory risks and opportunities, enabling informed decision‑making for products in development and legacy products seeking new indications or new markets. Cross‑functional Leadership Provide early, proactive regulatory input to development programs supporting the RA Global team, influencing clinical, CMC, and evidence generation strategies to support successful approvals. Ensure the team closely work with the RA global team for effective lifecycle management, including variations, renewals, post‑approval commitments, and safety‑related regulatory actions, maintaining compliance. Partner closely with the RA global team to integrate local regulatory requirements and strategy into overall product global regulatory requirements and strategy. Agency Engagement Serve as the senior regulatory interface with EMA, EU national authorities, leading scientific advice, regulatory meetings, and complex negotiations. People Leadership and Governance Lead, develop, and mentor the Regulatory Affairs team, ensuring clear accountability, role clarity, and capability development. Contribute to global regulatory governance, standardization, and continuous improvement initiatives across PDx. Support structured knowledge transfer, handover, and risk mitigation activities to ensure regulatory continuity. Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support Participate in due diligence for product development, acquisitions, and in‑licensing opportunities; assess regulatory risks and requirements. Support budget planning for the Regulatory Affairs function. Qualifications Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in the region. Expertise in regulatory pathways from development through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non‑clinical, and clinical components. Experience leading regulatory agencies meetings. Background in sterile injectables; radiopharmaceutical experience is a strong asset. Desired Characteristics Strategic thinker with strong analytical and problem‑solving skills. Excellent oral and written communication; ability to influence and negotiate effectively. Proven leadership and team development capabilities. Strong project management and organizational skills; ability to manage complex priorities. Inclusion And Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Behaviours We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Total Rewards Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world‑changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. Additional Information Relocation Assistance Provided: No #J-18808-Ljbffr
As the QA Associate, reporting to the QA Lead, you will be responsible for ensuring all batch release activities are performed in a timely, compliant, and efficient manner to meet both quality and logistical requirements. You will bring a strong quality perspective to the role, delivering customer and business needs as measured by the balanced scorecard, while operating safely and in full compliance with GMP, Quality, and EHS standards. Working closely with cross‑functional teams, you will help drive quality excellence and execution across the value stream, support Quality Operations across the campus, and contribute to a high‑performance culture focused on continuous improvement. Responsibilities Keep colleagues informed of current issues and developments as appropriate, ensuring compliance with all regulatory and company guidelines. Support quality improvement initiatives to continuously improve QA processes, methodologies, and tools to enhance efficiency and effectiveness. Maintain the retention program from a quality perspective and departmental metrics, ensuring on‑time batch release is consistently achieved. Generate and report key performance indicators as required. Support the quality review of batch‑related documentation prior to certification by the Qualified Person in accordance with GMP regulations. Review and approve deviations and investigations related to product quality to support timely closeout of quality records. Collaborate with cross‑functional teams to ensure seamless communication and understanding of quality objectives. Liaise with internal and external customers such as planning, QA, and production teams. Provide training as required to team members to enhance technical skills and knowledge of QA practices, and perform cross‑training to ensure flexibility within the QA department. Identify and assist in mitigating risks, ensuring timely resolution of issues. Manage site archive, storage, retrieval, and destruction processes. Assure the site and business are properly prepared for external and internal compliance inspections. Support and participate in site internal audits, regulatory audits, and third‑party audits, collaborating closely with business partners to ensure audit readiness at all times. Maintain compliance with company administrative procedures and policies in the department. Maintain compliance with EHS at all times and actively participate in EHS activities. Approve validation documentation and ensure validation activities are carried out in compliance with cGMP and company quality standards. Complete a reasonable level of overtime as required to facilitate the business needs. Carry out additional duties as deemed necessary by the Quality Leader. Qualifications and Requirements Professional Level 8 degree qualification or higher. Basic experience working within a GMP environment. Ability to work on own initiative and judgment with minimal supervision. Clear thinker who can analyze data to establish a direction to proceed. Relevant working knowledge of a regulated industry. Highly organised and attentive to detail. Capability to handle multiple tasks effectively and meet critical deadlines. Strong verbal and written communication skills. High degree of computer literacy. GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status, or other characteristics protected by law. #J-18808-Ljbffr
Job Description Summary The Systems QA Specialist provides Quality System (QMS) support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment. The role focuses on strengthening and maintaining compliant quality systems that enable safe, effective, and timely product supply. Working cross‑functionally with Manufacturing, Engineering, Validation, QC Microbiology/QC Labs, and Supply Chain, the Systems QA Specialist supports site performance through robust documentation, change control, deviation/CAPA management, risk management, and inspection readiness. Responsibilities QMS Management & System Oversight (Primary Focus) Support end‑to‑end execution of core QMS processes within assigned areas: Deviations/Nonconformances, CAPA, Change Control, Risk Assessments, Document Control, and Training Compliance. Ensure QMS records are initiated, assessed, progressed, and closed within SLA and meet data integrity and GDP expectations. Support routine system health activities: periodic reviews, metrics/KPIs, trending, and continuous improvement actions. Maintain and support inspection readiness through strong system discipline, clear traceability, and effective evidence packs. Change Control & Technical Quality Support (Sterile Systems) Support and/or coordinate change controls affecting sterile operations, terminal sterilisation processes, equipment, utilities, and supporting systems. Ensure changes are risk assessed (e.g., product impact, sterility assurance impact), appropriately documented, and aligned with validation/qualification requirements. Partner with Engineering/Validation to ensure implementation readiness: SOP updates, training completion, validation documentation, and effective handover to operations. Deviation Investigation & CAPA Support Support investigations for process, equipment, utilities, documentation, and microbiology/EM‑related events, ensuring structured root cause analysis. Drive high‑quality problem statements, impact assessments, containment actions, and timely CAPA development. Support CAPA effectiveness checks and ensure learnings are embedded to prevent recurrence. Terminal Sterilisation & Sterility Assurance Systems Support Provide QA system support for terminal sterilisation lifecycle activities, including sterilisation cycle documentation control and review support (as per site procedures). Change management and validation alignment for steriliser cycles, load patterns, and critical parameters. Support for sterility assurance risk assessments and periodic reviews. Interface with QC Microbiology for system‑level trending and governance of sterility assurance metrics (e.g., EM trends, excursions, recurring themes). Documentation & Training Compliance Author, review, and/or approve controlled documents (SOPs, WIs, forms, templates) supporting sterile operations and terminal sterilisation systems. Ensure training requirements are defined and tracked; support training effectiveness where required. Promote Good Documentation Practices (GDP), right‑first‑time behaviours, and consistent use of approved templates. Audit & Inspection Support Support internal audits, supplier quality interfaces (as applicable), and regulatory/customer inspections. Prepare evidence packs and system narratives. Support responses to observations and timely closure of actions. Ensure records are inspection‑ready with strong traceability and rationale. Continuous Improvement Identify opportunities to streamline QMS workflows while maintaining compliance (e.g., standardised investigation templates, improved change control quality, trending dashboards). Support site quality initiatives impacting sterile systems performance (e.g., CCS alignment, aseptic governance, documentation simplification). Required Qualifications Bachelor’s degree (or equivalent experience) in Science, Engineering, Pharmacy, or related discipline. Experience in GMP Quality Assurance or Quality Systems within sterile/aseptic manufacturing or similarly regulated environments. Hands‑on experience supporting QMS processes: deviations, CAPA, change control, documentation (and ideally risk management). Strong understanding of GDP and data integrity expectations. Effective communication skills and ability to collaborate across functions. Key Competencies Strong systems thinking and attention to detail; able to maintain compliant documentation and traceability. Structured problem solving and root cause analysis capability. Ability to manage priorities and timelines; confident in escalation when risks are identified. Collaborative mindset with the ability to influence quality outcomes without direct authority. Consistent focus on patient safety, product quality, and compliance. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Additional Information Relocation Assistance Provided: No #J-18808-Ljbffr
GE HealthCare is looking for a Systems QA Specialist in Cork, Ireland. This role involves overseeing the Quality Management System for sterile manufacturing, ensuring compliance in processes such as deviations, CAPA, and change control. The ideal candidate will have a relevant degree and experience in GMP Quality Assurance or Quality Systems within regulated environments. Strong documentation practices and communication skills are critical. Join a collaborative team dedicated to patient safety and product quality. #J-18808-Ljbffr
GE HealthCare is seeking a QA Associate in Cork, Ireland. The role involves ensuring compliance with quality and regulatory standards, supporting quality improvement initiatives, and maintaining timely batch release activities. Candidates should have a Level 8 degree and experience in a GMP environment. Strong analytical skills, attention to detail, and proficiency in communication are critical. Join GE HealthCare to contribute to a culture of quality excellence and continuous improvement. #J-18808-Ljbffr
Job Description Summary As a Shift Manager, you'll lead a team of approximately 125 colleagues, including 7 direct reports, serving as the accountable site lead during your shift to deliver excellence in safety, quality, service, cost, and people performance. This high-impact role places you at the core of our 24/7 operations, where you'll drive team engagement, foster collaboration across functions, and ensure seamless production in a world-class MedTech and Pharma manufacturing environment-perfect for leaders passionate about making a real difference in healthcare. At GE HealthCare Cork, you'll be part of a purpose-driven team committed to improving lives through advanced healthcare solutions, while enjoying a supportive culture, opportunities for growth, and the energy of a site that's continuously investing in innovation and its people. Job Description Responsibilities Safety & Compliance Champion a culture of safety and compliance, leading all emergency procedures and safety systems on shift. Ensure plant and equipment operate to the highest GMP, site, and corporate standards. Drive completion of all safety and compliance activities, including 5S and housekeeping audits. Quality Ensure all production meets established quality guidelines and regulatory expectations. Oversee batch documentation, inspection, and packaging processes for compliance. Support and lead continuous improvement initiatives to enhance product quality. Service & Delivery Monitor, record, and track production to meet scheduled targets. Communicate effectively with stakeholders using Lean Daily Management System (LDMS). Ensure detailed and effective shift handovers, maintaining standards across shifts. Collaborate with other Shift Managers and functional leads to ensure uninterrupted 24/7 flow of operations. Cost Management Track and deliver line performance against targets. Implement actions to improve Overall Equipment Effectiveness (OEE) and operational efficiency. Drive continuous improvement to reduce costs and improve yields. People Leadership & Engagement Lead, motivate, and manage the shift team, anchored by GE Beliefs. Foster high engagement by actively listening, recognizing achievements, and supporting development. Provide coaching, mentoring, and development feedback to team members. Ensure effective delegation and performance management, recognizing and rewarding achievements. Spend daily time on the floor, maintaining contact with shift personnel. Participate in recruitment and selection of team members. Ensure compliance with GEHC Cork HR policies and COREHR requirements. Build a culture of openness, psychological safety, and engagement. Cross-Functional Leadership & Collaboration Work closely with peers, support departments, and cross-functional teams to resolve issues and drive improvements. Ensure seamless collaboration and communication across shifts and functions to maintain 24/7 operational flow. Actively participate in site planning, forecasting, and problem-solving processes. Lean Ways of Working Embed lean principles in daily operations, driving standard work, visual management, and continuous improvement. Surface and drive continuous improvement initiatives, encouraging team input and supporting the suggestions scheme. Use lean tools to identify and eliminate waste, improve flow, and enhance value delivery. Communications Communicate regularly with the team, surfacing and addressing issues promptly. Lead business and shift communications, ensuring clarity on targets and priorities. Be active and constructive in meetings, driving shift performance. Ensure clear and consistent communication across all shifts and functions. Responsible for identifying the training requirements of personnel under their supervision. Responsible for allocating time and resources to ensure that personnel are qualified for and / or trained to perform their assigned tasks. Responsible for ensuring that personnel do not perform, or supervise, any task or process without the appropriate qualifications. Qualifications and Experience Professional degree level qualification (or equivalent) required. Lean and/or six sigma qualification preferred. Experience managing teams in a fast-paced, complex, regulated environment (MedTech or pharmaceutical manufacturing preferred). Strong decision-making, planning, and communication skills. Experience developing strong working relationships across shifts and support departments. IT, data analysis, and presentation skills desirable. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. Total Rewards Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-BG1 #LI-onsite Additional Information Relocation Assistance Provided: No To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Job Description Summary The Systems QA Specialist provides Quality System (QMS) support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment. The role focuses on strengthening and maintaining compliant quality systems that enable safe, effective, and timely product supply. Working cross-functionally with Manufacturing, Engineering, Validation, QC Microbiology/QC Labs, and Supply Chain, the Systems QA Specialist supports site performance through robust documentation, change control, deviation/CAPA management, risk management, and inspection readiness. This is a support role (not final release authority). The role contributes to quality decisions through thorough assessment, escalation, and documentation in line with site procedures. Job Description Responsibilities QMS Management & System Oversight (Primary Focus) Support end-to-end execution of core QMS processes within assigned areas: Deviations/Nonconformances, CAPA, Change Control, Risk Assessments, Document Control, and Training Compliance. Ensure QMS records are initiated, assessed, progressed, and closed within SLA and meet data integrity and GDP expectations. Support routine system health activities: periodic reviews, metrics/KPIs, trending, and continuous improvement actions. Maintain and support inspection readiness through strong system discipline, clear traceability, and effective evidence packs. Change Control & Technical Quality Support (Sterile Systems) Support and/or coordinate change controls affecting sterile operations, terminal sterilisation processes, equipment, utilities, and supporting systems. Ensure changes are risk assessed (e.g., product impact, sterility assurance impact), appropriately documented, and aligned with validation/qualification requirements. Partner with Engineering/Validation to ensure implementation readiness: SOP updates, training completion, validation documentation, and effective handover to operations. Deviation Investigation & CAPA Support Support investigations for process, equipment, utilities, documentation, and microbiology/EM-related events, ensuring structured root cause analysis. Drive high-quality problem statements, impact assessments, containment actions, and timely CAPA development. Support CAPA effectiveness checks and ensure learnings are embedded to prevent recurrence. Terminal Sterilisation & Sterility Assurance Systems Support Provide QA system support for terminal sterilisation lifecycle activities, including: Sterilisation cycle documentation control and review support (as per site procedures) Change management and validation alignment for steriliser cycles, load patterns, and critical parameters Support for sterility assurance risk assessments and periodic reviews Interface with QC Microbiology for system-level trending and governance of sterility assurance metrics (e.g., EM trends, excursions, recurring themes). Documentation & Training Compliance Author, review, and/or approve controlled documents (SOPs, WIs, forms, templates) supporting sterile operations and terminal sterilisation systems. Ensure training requirements are defined and tracked; support training effectiveness where required. Promote Good Documentation Practices (GDP), right-first-time behaviours, and consistent use of approved templates. Audit & Inspection Support Support internal audits, supplier quality interfaces (as applicable), and regulatory/customer inspections: Prepare evidence packs and system narratives Support responses to observations and timely closure of actions Ensure records are inspection-ready with strong traceability and rationale Continuous Improvement Identify opportunities to streamline QMS workflows while maintaining compliance (e.g., standardised investigation templates, improved change control quality, trending dashboards). Support site quality initiatives impacting sterile systems performance (e.g., CCS alignment, aseptic governance, documentation simplification). Key Interfaces Manufacturing / Aseptic Filling Operations (system support, documentation, deviation/change coordination) Engineering & Validation (qualification/validation alignment, sterilisation systems changes) QC Microbiology / QC Labs (EM trend governance, micro-related system actions) Supply Chain / Materials (change control, supplier quality topics as applicable) Quality Leadership / QP/QA Release Teams (escalation, risk assessment input, readiness support) Required Qualifications Bachelor's degree (or equivalent experience) in Science, Engineering, Pharmacy, or related discipline. Experience in GMP Quality Assurance or Quality Systems within sterile/aseptic manufacturing or similarly regulated environments. Hands-on experience supporting QMS processes: deviations, CAPA, change control, documentation (and ideally risk management). Strong understanding of GDP and data integrity expectations. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. Total Rewards Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Additional Information Relocation Assistance Provided: No To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Job Description Summary As a Process Engineer at GE HealthCare, you will play a pivotal role in optimising and sustaining the manufacturing processes that bring life‑changing medical technologies to patients worldwide. You’ll take ownership of day‑to‑day process performance, drive continuous improvement initiatives, and collaborate closely with cross‑functional teams to enhance quality, reliability, and operational efficiency. In this role, you will apply strong technical expertise, problem‑solving skills, and data‑driven thinking to ensure our processes are safe, compliant, and consistently delivering world‑class products. Supported by a culture of transparency, accountability, and collaboration—and grounded in our commitment to inclusion and integrity—you’ll have the opportunity to grow, innovate, and directly impact the future of healthcare delivery. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world‑changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Responsibilities As a Process Engineer, You Will Contribute To The Safe And Reliable Operation Of Production Equipment, Drive Continuous Improvement, And Support Ongoing Site Growth. Your Responsibilities Will Include: System Ownership & Asset Management Act as System Owner for selected manufacturing equipment and associated processes. Apply asset management techniques including equipment criticality assessments, condition‑based monitoring, lifecycle planning, reliability improvements, and preventive maintenance strategy support. Ensure equipment is included in calibration, maintenance, and reliability programs. Process Optimization & Equipment Performance Ensure production equipment operates in line with validated and operational requirements. Monitor equipment KPIs (including OEE), identify trends, and drive improvements in safety, quality, and productivity. Troubleshoot process issues in partnership with Maintenance, Quality, and Operations teams. Lead ongoing process and equipment development initiatives. Project & Technical Leadership Manage small to medium capital projects from conception through to validation (FAT/SAT/IOQ). Collaborate with contractors, vendors, project teams, and business units. Support new technology introduction and equipment commissioning. Lead and support CAPA investigations with robust root‑cause analysis. Compliance, Safety & Documentation Ensure GMP, regulatory, and safety requirements are fully met. Develop SOPs, reliability procedures, and documentation changes through change control. Serve as a Safety Champion and proactively eliminate recurring equipment issues. Contribute to quality investigations, CAPA actions, and continuous improvement initiatives. Team Collaboration & Leadership Mentor maintenance and utilities technicians. Work cross‑functionally to solve problems and drive improvements. Participate in daily and weekly operational meetings to ensure alignment with site objectives. Qualifications And Requirements Degree in Manufacturing, Process, Mechanical, or related engineering discipline or equivalent Solid engineering experience in a GMP, pharmaceutical, or process‑industry environment. Strong understanding of engineering standards, documentation, and validation lifecycle. Excellent communication, problem‑solving, and analytical skills. A proactive mindset with a passion for continuous improvement and operational excellence. Desired Skills Experience with CMMS/EAM systems. Knowledge of reliability techniques (RCM, FMEA, criticality assessments). Project management training or certification. Green belt or problem‑solving tool training. Strong leadership, coaching ability, and a collaborative approach. Why Join Us? You’ll be part of a forward‑thinking site that values innovation, asset reliability, digital optimisation, and continuous improvement. This role offers the opportunity to shape equipment performance, influence cross‑functional operations, and build technical leadership capability within a world‑class healthcare organization. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Total Rewards Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world‑changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No #J-18808-Ljbffr
