A day in the life of a CQV Engineer
In an industry as critical as Life Sciences, it is important to ensure that manufacturing facilities and equipment are up to scratch. Drugs and medical devices need to be developed through verified procedures or they cannot be considered as safe or reach the market. CQV Engineers play a central part in this process. They test and report on equipment and facilities involved in producing medical products to ensure they are fit for purpose.
The task load of CQV Engineers are varied, substantial, and stretch across the manufacturing process. But what does a day in the life of a CQV Engineer look like?
Generally, CQV Engineers are site based. Whether within a biotechnology or pharmaceutical manufacturing facility, you will find CQV Engineers at the centre of it all - amongst the equipment on the manufacturing floor, in laboratories, or conducting reports in their office.
Depending on whether the CQV Engineer is working on existing operational plant, or is project based, working hours may vary. Whilst working patterns tend to adhere to a normal Monday to Friday workweek structure for CQV Engineers who are site based, project based CQV Engineers may work more varied hours and shifts in order to meet the project timeline. Whilst shifts may not necessarily fall into exactly 9-5 working hours, a CQV Engineer’s workday will typically be an 8-hour shift, and some companies will offer additional overtime opportunities.
The size of the Quality Assurance team that CQV Engineers work within will depend on the size of the organisation and the project at hand. But their daily interaction is not limited to within their team. A CQV Engineer’s work stretches across varying stages of manufacture, meaning that they work alongside various stakeholders and engineering teams throughout.
Commissioning is a step in the manufacture process that ensures the facility, systems and equipment being used are designed and installed correctly under GMP regulation. Day-to-day, tasks within this area will include performing design reviews, factory acceptance testing (FAT), installation verification and functional testing. From this, the CQV Engineer will generate summary reports alluding to deviations found through testing.
Qualification is the stage whereby activities are undertaken to demonstrate the facilities, process and equipment are suitable to perform as specified by the Project Design. Tasks performed here will include verifying and documenting that the facility and equipment have undergone rigorous testing. Specific activities include design qualification, installation qualification, operation qualification and performance qualification. The CQV Engineer responsible will corroborate with contract documents, equipment specifications, project design documents and members of the Quality Assurance team.
At this stage, the CQV Engineer will pull together the data collected from their commissioning and qualification tasks. From this, they will evaluate and present scientific evidence as to whether the facility, processes and equipment are consistent with delivering a high standard product. Here is where the final stamp of approval (or recommendations for improvements) are given for the equipment used throughout production. It is a documentation heavy stage, so this day in a CQV Engineer’s life at this stage will likely see them office bound, conducting reports and producing paperwork.
Other CQV Engineer day-to-day tasks include:
· Performing GAP and risk assessments
· Performing safety reviews
· Compiling a CQV issues log
· Developing Standard Operating Procedures (SOP)
· Staying in regular contact with engineers, manufacturers and members of the Quality team on site
· Maintaining focus on the end of the project and ensure that all tasks every day are fulfilled according to GMP and GDocP (good documentation practices)
Interested in a CQV Engineer job?
The role of CQV Engineer is incredibly rewarding. You are on the front line of the Life Sciences industry, ensuring that the drugs and medical devices hitting the market are manufactured safely.
CQV Engineers are always needed in pharmaceutical and biopharmaceutical facilities across the globe. At Quanta, we are partnered with some of the world’s leading organisations, and our trusted Life Sciences recruitment team are skilled at making placements both locally and internationally. Check out our CQV Engineer jobs or get in touch with our life sciences team to discuss your application, or sign up for job alerts to be the first to hear about our opportunities.