You will be joining a fantastic team who are committed to creating sustainable solutions and driving technological progress to improve everyday life. Be a part of this journey to shape the future of science and innovation. Main Duties: Lead and support capital projects, applying advanced automation engineering principles in … construction, startup, and validation of complex process equipment and systems. Ensure adherence to industry standards for batch control systems, software development life cycle methodologies, 21CFRPart11, and GAMP. Develop detailed specifications, engineering documents, SOPs, and operating standards. Oversee and manage process control automation in more »
You will be joining a fantastic team who are committed to creating sustainable solutions and driving technological progress to improve everyday life. Be a part of this journey to shape the future of science and innovation. Main Duties: Lead and support capital projects, applying advanced automation engineering principles in … construction, startup, and validation of complex process equipment and systems. Ensure adherence to industry standards for batch control systems, software development life cycle methodologies, 21CFRPart11, and GAMP. Develop detailed specifications, engineering documents, SOPs, and operating standards. Oversee and manage process control automation in … control system automation, particularly in design, installation, programming, and validation of automated processes. Experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, and Rockwell Automation Factory Talk & ControlLogix PLC Platform. Proficient in creating, updating, and interpreting electrical design packages, including SDS, URS, IQ, OQ more »
St Neots, England, United Kingdom Hybrid / WFH Options
Ennov
English (ideally with business French). Nice to Haves Data Protection Officer certification. Knowledge of regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21CFRPart11). Experience with Agile or Scrum Methodologies. Proficiency in Electronic Document Management Systems (EDMS) and other quality management more »
using industry-standard software lifecycle management tools such as Jira, Confluence, and AHA! Previous exposure to applying industry compliance and quality standards (GLP, GMP, 21CFRPart11) in software products. Effective communication and stakeholder management skills to facilitate seamless collaboration and alignment across diverse stakeholders. If you possess a passion for driving … innovation in the biopharma sector and are equipped with the requisite skills and experience, we encourage you to apply and be a part of our transformative journey. more »
of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data. Perform stability study programme activities, storage of in process, and final products samples and retention sample management System owners more »
