Description
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Job Purpose;
- To provide specialised validation support to production engineering/Manufacturing. To have input into documentation requirements and carry out practical aspects IQ, OQ, and PQ validation tasks.
Major Accountabilities;
- Support Manufacturing/Process development with validation requirements of setting up the manufacturing facility.
- Ensure all requirements are laid out in protocols covering all aspects of equipment performance.
- Perform and manage all work in a safe manner and in compliance with local procedures/company standards and current health, safety and environment legislation.
- Ensure health & safety procedures are followed ie near miss accidents, Workstation assessment etc.
- Accountability for achieving validation timescales and highlighting potentially problematic processes.
- Help to design Factory acceptance test for complex equipment.
- Provide input to product validation requirements
- Setting key validation criteria and specifications.
Key Performance Indicators;
- Equipment validated to pre agreed milestones.
- Sign off of completed documentation
Job Dimensions;
- Responsible for self and validation tasks carried out by others although no direct reports.
Ideal Background;
Education: Educated to degree level in engineering or science preferable.
Manufacturing and process improvement experience desirable.
Experience: 5-10 years experience in all stages of equipment validation including production of documentation and working to project milestones.
Experience of setting up facility from scratch and validating line through to end of PQ.
Experience of manufacturing and/or engineering in previous roles.
Understanding of the requirements of Medical diagnostics manufacture.
Knowledgeable of ISO:13485 FDA 21 CFR 820 regulations
hy-phen Limited is acting as an Employment Business in relation to this vacancy.