Technical Validation Specialist
A well-known international pharmaceutical company with sites around the globe is looking to hire a Technical Validation Specialist. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- Validating of pharmaceutical and biotechnology facilities including HVAC, manufacturing equipment, clean utility systems and computer system validation.
- Writing and maintaining DQ, IQ, OQ, FAT and SAT protocols for manufacturing facilities & equipment.
- Executing DQ, IQ, OQ, FAT and SAT protocols.
- Generating documentation for and leading Detailed Design reviews and project Risk Register reviews.
- Working to cGMP standards for MHRA and EU regulatory approval.
- Reviewing and approving functional specifications, change controls and deviations as well as executed test documentation including IQ/OQ/PQ.
- Environmental mapping of facilities.
- Writing commissioning documents and commissioning of equipment.
- Working with the life cycle approach to validation.
- Familiarity with GAMP and 21 CFR Part 11 Example Projects.
- Validating Testo environmental monitoring system.
- Validating of te facility to accommodate melt, spray and congeal equipment.
- Validating of the facility to accommodate fluid bed dryer, granulator and coater.
- Validating of the Process Control System.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.