Emily Mills at CK Technical is recruiting for a Validation Engineer to join a company in the pharmaceutical industry at their site based in Hatfield on a contract basis, to support for 18 months.
Our client is a leading, global, research and development based pharmaceutical company.
This role is located in Hatfield. The site is easily commutable from Stevenage and North London.
This job is responsible for the provision of validation and project support to manufacturing and packaging operations.
This includes the implementation, qualification and validation of processes and equipment used for the manufacture, packaging, testing, storage and distribution of marketed drug products.
Duties will include to:
- Lead commissioning, qualification and validation (CQV) activities within the manufacturing/packaging facilities at site.
- Develop qualification protocols for all new projects.
- Review and approval of vendor documentation to support on-site Good Documentation Practice (GDP) requirements.
- Support project leaders in the coordination of commissioning and qualification activities in line with the project schedules and operational requirements.
- Execute IQ/OQ protocols for site utility systems, HVAC, general facility, packaging and process equipment.
- Ensure that current Good Manufacturing Practices (cGMPs) and Good Engineering Practices (GEP) are applied in all areas of responsibility.
- Provide CQV support for production projects to ensure the completion of key project deliverables including vendor assessments, design reviews and factory acceptance testing.
- Support the generation and archiving of related project documentation including validation plans, test protocols and reports.
- Coordinate with quality department to ensure an acceptable resolution of outstanding CQV incidents, CAPA actions and deviations.
The ideal candidate for this role will have:
- HNC/Degree level in engineering or an appropriate scientific discipline.
- Demonstrated experience within the pharmaceutical industry including commissioning, qualification and validation.
- Availability for EU travel for Factory Acceptance Testing of new equipment.
- Experience of document creation and execution at various stages of qualification in the validation lifecycle.
- An understanding of current EU GMP and US FDA regulatory requirements.
- Appreciation of GAMP5 and Computer Systems Validation including 21 CFR Part 11 and EU GMP Annex 11 compliance.
For more information or to apply for this position, please contact Emily Mills on 01246 457710 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46501 in all correspondence.