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- ...control processes and regulatory guidelines. Adhere to data integrity principles and ensure automation systems are compliant with 21 CFR Part 11. Work closely with process engineers, IT, quality, and validation teams to ensure seamless integration and operation of...SuggestedContract workFor contractors
- ...technologies Key Responsibilities: Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards. Collaborate with R&D teams to ensure quality considerations are integrated...SuggestedPermanent employmentFull timeWorldwideWicklow Town, Co. Wicklowa month ago
- ...analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR USP and EP guidelines. • Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its...SuggestedFull timeContract workWork at officeWorldwideShift work
Orion Engineering Services Limited
Cork11 days ago $173.2k - $272.6k per annum
...manufacturing environment. Expert knowledge of relevant regulations (FDA/EU/ICH/WHO), with emphasis on emerging AI regulations and guidance; 21 CFR Part 11, 210, 211, EU Annex 11 and Annex 15, data integrity, and local regulatory expectations as well as industry standards, such as...SuggestedLong term contractFull timeFor contractorsHybrid workVisa sponsorshipWork at officeLocal areaRemote workRelocationMonday to ThursdayFlexible hoursShift work3 days week- ...commissioning and validation Overseeing automation budgets, project timelines, and external vendor partnerships Ensuring compliance with 21 CFR Part 11 and GxP requirements Supporting internal and external regulatory audits Ensuring automation systems comply with...SuggestedPermanent employmentFor contractorsLocal 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
- ...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...SuggestedRemote jobPermanent employmentFlexible hours
- ...and automation workflows. Configure and support middleware and integration platforms. Ensure all integrations comply with GxP, 21 CFR Part 11, and data integrity (ALCOA+) requirements. Participate in Computer System Validation (CSV/CSA) activities (IQ/OQ/PQ...SuggestedLocal area
- ...Management Systems & Compliance Lead and manage the company’s QMS, ensuring compliance with ISO 13485, EU Medical Devices Directive, and 21 CFR Part 820 Oversee core quality processes including CAPA, non-conformances, complaints, change control, and supplier quality Ensure...SuggestedPermanent employment
€80 per hour
...Bachelor's degree in Computer Science, Engineering, or a related field. ~ Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. ~5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals...SuggestedHourly payFull timeContract work- ...update SOPs and training materials Authoring engineering documents, risk assessments (e.g., FMEA), and test plans per GAMP 5; enforce 21 CFR Part 11 and ALCOA+ data integrity (audit trails, electronic signatures, role‑based access) Providing site support, troubleshooting...SuggestedPermanent employmentFor contractorsLocal area
- ...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
€61k - €64k per annum
...in employment. Moreover, Notre Dame prohibits discrimination against veterans or disabled qualified individuals, and complies with 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a). We strongly encourage applications from candidates attracted to a university with a Catholic identity...SuggestedFull timeTemporary workSummer workWork at office- ...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...SuggestedPermanent employmentFull time
- ...product development, commercialization, and enterprise‑level process initiatives. • Knowledge of regulatory environments, including 21 CFR, QSR 830, ISO 13485, and ISO 14971. • Master’s degree (e.g., MS, MBA, Engineering) preferred. • PMP certification preferred. •...SuggestedWorldwide
€50k - €60k per annum
...relevant engineering experience within an ISO certified medical device company. Strong understanding of ISO 13485 standard, FDA Part 21 CFR 820 and other medical device regulation. Excellent problem-solving and root cause investigation skills. Proficient in using...Permanent employment- ...Quality Management System (QMS) to ensure full compliance with applicable U.S. and international regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 27001, and other applicable regulatory requirements. This position supports both internal processes and...Permanent employmentHybrid work
- ...regulatory requirements for laboratory equipment qualification and analytical testing. Understanding of Data Integrity & CSV, including 21 CFR Part 11 / Annex 11 compliance for computerised systems. What you'll get in return Flexible working options available. What...Flexible hours
- ...or Pharma environment (6+ years for Senior level). Strong experience preparing for and participating in ISO 13485 and/or FDA QSR 21 CFR 820 audits - with confidence interacting with regulators and customers. Deep knowledge of ISO and FDA regulations, with additional exposure...Worldwide
- ...required for the role: ~2+ years medical device assembly experience ~ Strong computer skills ~ Knowledge of ISO 13485 and FDA 21 CFR 820 ~ Internal audit experience (preferred) ~ Independent decision-maker; able to multitask and prioritise ~ Strong interpersonal and...Permanent employmentFlexible hours
- ...systems in a cGMP‑regulated environment. ~ Proven track record in delivering and managing MES solutions. ~ Knowledge of FDA cGxP, 21 CFR Part 11, and software system validation. ~ Hands‑on experience with Siemens PLCs, SCADA systems, and AVEVA (OSIsoft) PI Data...Full time
- ...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
- ...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
- ...Bachelor's degree in Computer Science, Engineering, or a related field. ~ Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. ~5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals...Contract work
€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- .... Your new role Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meets 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s, and Corporate & local compliance requirements. Support the introduction of new instrument systems...Contract workLocal area
- ...and metal components in manufacturing setting. Use of precision hand tools. Understand general principles of EN ISO 13485 & FDA 21 CFR 820 would be advantage. If you are interested in this opportunity, please apply with your up-to-date CV today. sarah.flynn@...Permanent employmentContract workTemporary workDay shiftAfternoon shiftWeekday work
- ...NPI) projects. Plant commissioning and start-up experience. Working knowledge of ISA-88 / ISA-95 standards. Familiarity with 21 CFR Part 11 and EU Annex 11 regulatory requirements. Experience with DeltaV Continuous Process Systems (CPS) and SCADA platforms....Hourly payLong term contractContract workLocal areaWorldwideFlexible hours
- ...flexibility and cross-functional expertise. This role may be for you if you have: A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes. Proven ability to apply quality assurance...Permanent employmentLocal area
- ...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
