Beschreibung
Process Validation Engineer
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Process Validation Engineer to join them on a long term basis.
Start Date: ASAP
Working Language: English
Rate: Excellent
THE ROLE
*To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements are addressed.
*Assuming responsibility as the technical expert for the validation process and its compliance with company standards.
*Resolve & manage technical and operational problems
*Suggest and implement innovation and continuous improvements within the validation process
*Implement initiatives in the validation process that will deliver customer value at the lowest cost
*Build cross functional and cross-departmental support and manage relationships both internally and externally to facilitate successful team behaviour within the quality systems functional area
*Review and approve validation master plans, protocols, summary reports and other documentation associated with validations, as appropriate for each validation exercise
*Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
*Ensure all validation activities are carried out and reported in a timely manner
*Ensure compliance through assisting in audits.
*Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
*Lead by example, inculcating the Credo values in all actions within the workplace
YOUR PROFILE
*Prepare reports and support the EMEA Validation Manager in the GRQP activities
*Responsible for collecting the deliveries of the site GRQP activities
*Experience in process validation, medical devices, mechanical and chemical processes - 21 FDA 820
*A degree in Quality Management
*Techical skills: 21 FDA 820, ISO 13485
*Familiar with working in a matric- organisation
*Medical device experience is a plus
If it sounds like your next challenge, please send us your CV and we will contact you shortly to discuss it further.