A well-known international pharmaceutical company with sites around the globe is looking to hire a CQV Engineer. 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 and clean utility systems. Computer system validation.
Writing and maintaining URS.
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 approval of 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.
Examples of possible Projects:
Validation of Testo environmental monitoring system
Validation of the facility to accommodate melt, spray, congeal equipment
Validation of the facility to accommodate fluid bed dryer, granulator & coater
Validation of Process Control System
Skills and Requirements:
Life sciences Degree
More than 5 years experience of Validation activities in the Pharmaceutical, Biotechnology or Medical Devices area
Experience of executing DQ, IQ, OQ, FAT and SAT protocols
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 Will Hitchcock at 0203 078 9554 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.