Crest Solutions have an open opportunity for an experienced CSV Engineer to join our team on a 12 month contract.
The Computer System Validation Engineer plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and system changes. The successful candidate will provide support for the validation activities associated with equipment and systems ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. They will also provides support for the periodic validation reviews and administration of the site validation master plan.
- Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.
- Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
- Assist in development of validation strategy and validation plan for computer system validations.
- Assist in resolution of deviations/ exceptions during qualification activities
- Assist with change control activities in accordance with site procedures
- Attend identified training required to fulfil the role of QA Computer System Validation Engineer
- Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development.
- Participate in cross-functional teams as required.
Required Qualifications and experience:
- Hons. Degree Quality/ Manufacturing / Engineering / Science or related field
- Minimum 5 years of related industry experience.
- In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry.
- Strong knowledge of system development life cycle and GAMP.
- Minimum 3 years validation experience with automated manufacturing systems.
Why Join Crest Solutions?
At Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
- Competitive salary
- Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme
- A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment.
- A structured approach to professional development opportunities with an educational assistance program