Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease
4 days on-site required, 1 day home-based
Responsible for supporting the qualification and validation activities regarding CSV. Developing qualification/ validation documents (e.g. protocols and reports) satisfying internal and external regulatory expectations. They will perform independent execution of validation activities required for the CSV to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
Ensure safe and compliant cGMP operations.
Maintain permanent inspection readiness and actively support regulatory inspections.
Interface with operators and serve as validation SME. Learn the procedures, analytics and document any known sensitivity.
Follow the BMS validation procedures
Coordinate department validation activities within the project schedule.
Develop the protocols for validation, re-qualification and revalidation of equipment/System and system connected to.
Conduct training for internal customers on protocols associated with equipment, systems, and processes under validation.
Perform investigations associated to validation activities (e.g. deviations or OOS during validation studies).
Prepare written reports/summaries from validation studies
Provide technical input and investigation support for validation related investigations, ensuring compliance with validated state of the process.
Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process.
Review and revise the content of technical documentation (e.g. investigations, changes, SOPs, Technical specification) ensuring compliance with validated state of the process.
Interact with other teams including Process Engineering and Support, Operations and QA
Foster strong inter-team relationships to achieve common project goals
Support the tracking of team metrics and manage completion of objectives and projects
Our client is looking for someone who has:
MS in Engineering/Technical discipline or experience equivalent.
Minimum 3 years' experience in validation of system (CSV)
Expert knowledge of international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
Deep knowledge of CSV, automation and data integrity process
Hands-on experience with new MES System, manufacturing software
Experience working with external parties and/or leading cross-functional teams
Possess strong verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Good level of English and French
***This position has now been filled, please contact email@example.com to be informed of future similar positions***