The Client: A Global category Market leader in Consumer Health and wellbeing
ON A MISSION TO CREATE HEALTHY PEOPLE WITH HAPPIER LIVES!
Location: Greater Manchester
Role: Validation Engineer / Technologist
- An exciting newly created role on an expanding site!!
- You will own and lead the transfer of processes from production to R&D, validate automated technology processes and scale up to manufacturing.
- To lead the validation activities for manufacturing facilities, utilities, processes, equipment and software systems as part of the quality management system (QMS)
- Lead Risk Assessments, ensuring controls are in place for validation, equipment and process (FMEA)
- Act as a Subject Matter Expert (SME) in audits
- You will provide expertise in the management of validation including ownership of the validation master plans and SOPs, validation documents, work instructions, cleaning validation and validation protocols
- Achieve compliance with current regulations and legislation for Good Manufacturing Practice and execution of validation activities of equipment and systems prior to implementation in the manufacturing environment.
- Perform quality risk assessments to support validation and change management activities.
- Review / approve validation documentation produced by the validation team.
- Perform the witnessing of supplier performed validations to ensure compliance with GMP.
- To project manage the validation of new equipment and systems from design to implementation
- Perform quality risk assessments for new equipment / systems as part of the change control process.
- To assist with the change control process
Is this you?
- Graduate or master's qualified - Technical, Engineering or Scientific
- Computer Literate - Microsoft
- R&D, Validation, Process Technology and Quality Systems experience grained through relevant roles
- Ability and natural desire to challenge existing systems, processes and practices
- Project leadership skills and stakeholder engagement / management
- Project ownership and ability to manage multiple projects
- Evaluation and validation of processes, exposure to automated technology process and packaging systems - fill nd pack preferred
- Experience of continuous improvement of validation processes