Computer System Validation Engineer
Are you looking for a new career challenge? Do you want to work for a company that realise their people are the key to success and as such, demonstrate their company values every day. That means they need great people who want to be part of a growing business, widening the customer base and enhancing their customers experience and expectations of us, by solving their problems on a daily basis.
Our client, a systems integrator that provide high-quality systems solutions to customers across several sectors, are looking for 2 Validation Engineers.
The Validation Engineer will be responsible for ensuring that all manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements and GMP regulatory requirements.
Applicants must have the presence to promote the company image and ensure that this is enhanced by successful implementation of systems.
This will be an interesting and varied role, and the opportunity to progress within the team will be available to the right candidate. Appropriate training will be provided where required and in line with business requirements.
Applicants must have the ability to work on customers sites on their own. They will represent and enhance the company's image in related areas. They should be able to quickly gain the confidence of customers and internal staff. A "can do" positive attitude is required with the desire to extend their skill set, take on board new challenges and to help the company grow its reputation and customer base.
Ability to work as part of a team on a day to day basis to ensure that all projects are delivered on time, under budget, with the required quality that our clients expect and in line with the our/Client Quality Management System. The successful candidate should have the ability to be able to work with minimal supervision on smaller projects or as part of a team on larger projects.
The successful candidate will be required to mentor junior members of staff and be actively involved in their development. The candidate will be expected to produce project documentation suite such as design documentation and test specifications and expected to review documents produced by junior engineers.
The role -
At least 5 years experience in Validation (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).
Strong cGMP, GAMP and GxP knowledge with knowledge of FDA 21 CFR Part 11, Annex 11 regulation.
Must have strong ability to organize and manage multiple tasks in a fast-paced environment.
Demonstrated understanding and hands-on experience generating and reviewing validation lifecycle documents.
Strong interpersonal skills, excellent review and analytical skills.
Strong commitment to customer service and satisfaction are essential.
Capable of building, cultivating and maintaining strong trusting client relationships.
Strong written and verbal communication skills.
Self-motivated and a quick learner of business processes and technologies.
A working knowledge of or hands-on experience with Pharmaceutical, Biotech and Med Device production processes.
Ability to discuss technical aspects of validation and GxP testing with clients.
Strong attention to detail regarding documentation is a must.
Must be well organized and capable of working effectively within a multi-disciplinary team.
You will take home a competitive salary, health insurance, a workplace pension and some flexible working hours with an early Friday finish.
To apply, please send an up to date CV along with your salary expectation. Please note that only applications from those eligible to work in the UK without sponsorship can be accepted.
To find out more about Huxley Engineering, please visit www.huxleyengineering.com
Huxley Engineering, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales