our customers to document the qualification of Cytiva equipment on the customer site. This position reports to the Qualification Content Engineering Manager and is part of the Qualification Service team located at the Marlborough facility in MA and will be an on-site role. What you will do: Support … information and training content for Field Service Engineering team. Who you are: Degree in Engineering or significant technical/quality service background. Familiarity with 21CFRPart11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of experience in associated More ❯
s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21CFRPart11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯
Oxfordshire, Oxford, South East Hybrid / WFH Options
Computer Futures
s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21CFRPart11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯
Oxford, Oxfordshire, United Kingdom Hybrid / WFH Options
Computer Futures
s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21CFRPart11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯
manchester, north west england, United Kingdom Hybrid / WFH Options
Factorytalk
Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21CFRPart11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required More ❯
Advanced REST Client or SOAPUI. Experience with software validation to ISO 13485 or other regulated environments. Understanding of regulatory compliance frameworks such as FDA 21CFRPart 11. KEY WORKING RELATIONSHIPS Internal Process owners and stakeholders across the to test plans are agreed and carried out. Relevant More ❯
process). Maintaining detailed records and documentation of validation activities. Validating lab instrument software, managing change control, and configuration activities, with knowledge of 21CFR part11 requirements. ABOUT YOU: The ideal candidate will hold a bachelor's degree in a scientific discipline and have prior experience in analytical More ❯
team Requirements: 8+ years experience of life sciences automation with growing levels of responsibility In depth knowledge and illustrated experience of working with GAMP, 21CFR Part11 etc. Excellent ability for working with people and leading teams Energy, passion and vision to drive growth strategy Technical background in More ❯
team Requirements: 8+ years experience of life sciences automation with growing levels of responsibility In depth knowledge and illustrated experience of working with GAMP, 21CFR Part11 etc. Excellent ability for working with people and leading teams Energy, passion and vision to drive growth strategy Technical background in More ❯
specifications, technical reports, risk assessments). Experience with additional PLC/HMI/SCADA manufacturers. Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11. Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need. More ❯
specifications, technical reports, risk assessments). Experience with additional PLC/HMI/SCADA manufacturers. Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11. Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need. More ❯
documents (specifications, technical reports, risk assessments) Experience with additional PLC/HMI/SCADA manufacturers Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11 Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical More ❯
documents (specifications, technical reports, risk assessments) Experience with additional PLC/HMI/SCADA manufacturers Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11 Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical More ❯