Technical Validation Specialist

Job Type:
Permanent
Job Sector:
Engineering, Health, Medicine, Manufacturing, Scientific
Region:
South East
Location:
Sandwich
Salary:
£55 to £55 per hour
Salary Description:
Competitive
Posted:
09/01/2020
Recruiter:
Next Phase Recruitment
Job Ref:
V-46016

We have a very exciting new position available for a Commissioning, Qualification & Validation Engineer for a 6 month contract in Sandwich, Kent UK. You will work for a market leading pharmaceutical company based at the Discovery Science Park as a consultant or freelancer. As is common with these contracts there is a chance of an extension after the initial 6 months. Below, a list of the responsibilities the role entails and also the types of projects you might work on if successful.
 

- Validation 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
• Review 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 life cycle approach to validation
• Familiarity with GAMP and 21 CFR Part 11

Example Projects

• Validation of Testo environmental monitoring system
• Validation of facility to accommodate melt, spray, congeal equipment
• Validation of facility to accommodate fluid bed dryer, granulator & coater
• Validation of Process Control System

For more information and a chance to apply please get in touch with me directly.

Contact Details:
Next Phase Recruitment
Tel: 01403 216216
Contact: Deborah Hunter
Email:

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