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- ...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...SuggestedFull 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...SuggestedPermanent employmentFull 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. ~...SuggestedPermanent employment
- ...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
- ...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
- ...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
- ...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
- ...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
- ...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...SuggestedPermanent employment
- ...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
- ...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
- ...Development (GDD) Group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820. Manage review and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/...SuggestedFull timeFixed term contractWorldwide
- ...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...SuggestedPermanent employmentLocal area
- ...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
- ...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...SuggestedPermanent employmentLocal area
- ...colleagues in development of site contamination control strategies, aligned with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S. Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing...Remote jobFull timeWork at officeWorking Monday to Friday
- ...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...Permanent employmentFull timeContract workWorldwide
- ...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,...Permanent employmentFull timeContract workNo agency
- ...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
- ...accordance with fair chance laws. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from...Long term contractFull timeLocal areaRemote workFlexible hours
$10k per annum
...retirement plan akin to a traditional ROTH 401(k) offering. *Recruitment Incentive* Newly appointed Border Patrol Agents (as defined in 5 CFR 575.102 ) will be eligible for up to $20,000 in incentives. The first $10,000 will be paid upon successful completion of the Border...Long term contractFull timeImmediate startRelocationNight shift- ...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
- ...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...Full timeRelocation package
- ...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...Full timeLocal area
- ...preferred. Professional PM Certification (Project Management Professional [PMP] or equivalent Experience in regulatory environments (21 CFR, QSR 830, ISO 13485:2003, ISO 14971, Risk Management), medical devices preferred. What Great Looks Like: An ideal Senior...Hybrid workWorldwide
- ...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
- ...Development (GDD) Group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820. Act as the interface between R&D and the commercial manufacturing sites during device/combination product development and...Full timeFixed term contractWorldwide
- ...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
- ...users with defining authoring and documenting system use in user admin and maintenance SOPs · Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements as well as requirements from EU Annex 11 and all Data Integrity...Full timeLocal area