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- ...Historian, OEE desired. Knowledge and experience of computer system life cycle concepts and FDA regulatory requirements, including 21 CFR Part 1 desired. Desired Soft Skills: Excellent analytical and problem-solving skills to be applied in electrical design,...SuggestedPermanent employmentFull timeContract workNo agency
- ...Support commissioning, qualification, and validation activities (FAT, SAT, IQ, OQ, PQ) Ensure systems comply with GMP, GAMP 5, and 21 CFR Part 11 requirements Troubleshoot and resolve automation and control system issues Provide automation support to manufacturing,...SuggestedFull time
- ...enterprise systems (SAAS /cloud-based systems) Experience with automated equipment (SCADA/BMS / DCS) Solid knowledge of GxP FDA 21 CFR Part 11 EU Annex 1 and ISPE GAMP 5 guidelines. Experience in a Quality or Validation Role within Pharma sector At least 2 years of...SuggestedFull timeLocal area
- ...manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance...SuggestedPermanent employmentFull timeContract workWorldwide
- ...VBA macros) to increase efficiency while ensuring regulatory compliance, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11. Identify and implement continuous improvement opportunities, including leveraging Artificial Intelligence...SuggestedFull timeWorldwideFlexible hours
- ...manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S...SuggestedPermanent employmentFull time
- ...global operational priorities. Oversee and ensure that all PMS & CE activities comply with applicable regulations including FDA (21 CFR Part 801 21 CFR Part 820) EU MDR/IVDR (Annex I II) and regional requirements across APAC LATAM and MEA. Proactively monitor regulatory...SuggestedFull timeLocal areaWorldwide
- ...ability to work collaboratively and communicate effectively with cross-functional teams. A strong understanding of GMP GAMP5 and 21 CFR Part 11. Strong communication interpersonal skills and stakeholder engagement experience. Demonstrated leadership capability or project...SuggestedFull time
- ...Support risk-based validation approaches for new and existing systems Ensure CSV activities comply with cGMP GAMP 5 Annex 11 and 21 CFR Part 11 Support project teams to align validation activities with project timelines Participate in validation risk assessments to...SuggestedFull timeLocal area
- ...similar platforms Knowledge of industrial communication protocols (e.g. Profinet, Profibus, Modbus, OPC) Familiarity with GAMP 5, 21 CFR Part 11, and Annex 11 Experience supporting system upgrades, migrations, or site expansions Exposure to historian systems and data...SuggestedHourly payLong term contractContract workLocal areaWorldwideWork visaFlexible hours
- ...Role: ~ Degree in science or engineering. ~3–5 years’ experience in medical devices. ~ Strong knowledge of ISO 13485 and FDA 21 CFR 820. ~ Strong understanding of MDR and FDA submissions. ~ Auditing experience (internal/external) is a plus. ~ Validation experience...SuggestedPermanent employment
- ...responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports...Suggested
STERIS Canada Corporation
Westport, Co. Mayo4 days ago - ...ThinManager and OSIsoft PI Data Historian. Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards 21 CFR Part 11 and Annex 11. Working knowledge of network architecture technologies including TCP/IP Routing Switching Network IDS/IPS...SuggestedFull timeLocal area
- ...Perform and review analytical testing (routine non-routine method validation and technical transfer) ensuring compliance with ICH CFR USP and EP guidelines. Validate and maintain laboratory equipment including calibration troubleshooting and qualification (IQ/OQ/PQ)...SuggestedFull time
- ...several cross-functional disciplines both within and outside of the function and organization. ~ Good working knowledge of ISA95 and ISA88 CFR (Code of Federal Regulation) Part 11 EU (European Union) Annex 11. ~ Excellent communication skills with the ability to formulate...SuggestedFull timeRelocation package
- ...laboratory systems in compliance with FDA EMA and global regulatory expectations. Ensure adherence to GxP regulations including 21 CFR Part 11 EU Annex 11 GAMP 5 and data integrity principles (ALCOA). Develop review and approve CSV documentation including Validation...Full time
- ...access management. - Author and maintain CSV documentation (URS, FS/CS, IQ/OQ/PQ, test scripts, SOPs). - Ensure compliance with 21 CFR Part 11, EU Annex 11, and Data Integrity standards. - Collaborate with CSV Lead, System Integrators, Site IT, and Operations. - Act...Permanent employmentFull time
- ...underlying material science, manufacturing processes, biocompatibility, sterilization adaptability, and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) of the products. Complex Sales Competency: Demonstrated ability to engage in professional dialogue with...
Collins McNicholas Recruitment
Galway1 day ago - ...understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and...Remote jobPermanent employmentFlexible hours
- ...documentation skills and attention to detail. ~ Experience with process plant commissioning. ~ Good working knowledge of ISA88, ISA95, CFR (Code of Federal Regulation) Part 11, EU (European Union) Annex 11. ~ Strong team player with the ability to develop relationships...Full time
- ...experience in the medical device industry. ~ Strong knowledge of quality systems, measurement techniques, FDA & ISO standards (ISO 13485, 21 CFR Part 820). ~ Proven CAPA and root cause problem-solving experience. ~ Solid background in test method and process validation. ~...Permanent employment
- ...platforms related to AI/GenAI. Proficiency in star schemas and data modeling tools. Knowledge of industry regulatory requirements (CFR Part 11, GxP, CSA). Stream processing experience (Kafka, Flink). Cloud certifications. In order to be considered for this...Permanent employmentLocal area
- ...automation engineering with PLC/HMI/SCADA software development experience in GMP pharmaceutical environments. Strong knowledge of 21 CFR Part 11 requirements for automated systems. Experience with plant start-ups and/or new product introductions to pharmaceutical...Full time
- ...project documentation is completed in adherence to the latest pharmaceutical industry standards and regulations including GMP GDP and 21 CFR Part 11. Requirements Key Requirements Bachelors Degree in IT Computer Science or a related discipline. Minimum 8 years...Full time
- ...position requires strong technical expertise, leadership capabilities, and a deep understanding of regulatory standards such as FDA 21 CFR Part 820 and ISO 13485. You’ll also manage budgets, vendor relationships, and safety initiatives, while implementing modern maintenance...For contractorsRelocationFlexible hoursAfternoon shift
TE Connectivity Corporation
Galway2 days ago - ...applicable international regulatory and industry standards, including ISO 14155 (GCP), ICH E6, the Declaration of Helsinki, and FDA 21 CFR Part 11. The successful candidate will possess the technical proficiency to perform all necessary activities related to CoreLab non-...Full timePart timeFixed term contractImmediate start
EURAXESS Ireland
Galway18 hours ago - ...Engineering or related technical field. ~ Hands-on experience with risk management (EN ISO 14971). ~ Strong knowledge of FDA QSR (21 CFR 820), EU MDD, and relevant standards. ~ Prior experience with US FDA submissions is a plus. For a confidential discussion and...Permanent employment
€80k - €90k per annum
...related technical field. * 6 years QA, Quality System or regulatory experience in the medical industry. * Strong knowledge of FDA 21 CFR Part 820, ISO 13485:2016, EU MDR and international regulations. * Excellent communication, leadership and problem-solving skills....Permanent employment- ...and industrial communication protocols Strong understanding of regulated industry documentation and validation standards (GAMP, 21 CFR Part 11, etc.). Proficient in generating technical documentation for both internal and customer-facing use. Comfortable working in...Permanent employmentFull timeImmediate start
- ...support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.). Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements. Review and approve user requirements, validation documentation,...Remote jobWorldwide
