£32,000 - £45,000 DOE
Premier Engineering are currently searching for a Validation Engineer to join one of our major client in Leeds within the Medical Devices sector to join them as soon as possible. The role itself is down to continuous growth within the business as well as an increase in orders.
Please find some details below regarding what they are looking for
- To provide our customers with a positive and proactive experience by delivering great quality project work on time and on budget in various types of project.
- To work as an integral part of a customer’s team on their site.
- You will need to understand the customer’s problems and the key drivers for change to enable you to use your skills and experience to solve the customer’s problems in a timely manner.
- Delivery of Project Work from yourself and the customer’s team of Engineers in line with agreed timescales
- Ensure that Customer experiences a proactive approach to solving their problems.
- Assist PM in developing the relationships within the customer’s site to help build business with them.
- Ensure that all tasks are carried out within budget.
To ensure that project deliverables are issued on time through effective and sometimes innovative utilisation of the Project Team’s time and skills.
To supervise and monitor the customer’s suppliers in delivery of suitable equipment on time, to the relevant pharmaceutical standards.
Planning & Organisation:
Using planning methods such as Gantt Charts to monitor project progress and identify where issues arise.
To identify opportunities for improvement in efficiency and usability of the companies Quality Management System
To identify training opportunities in self and other ITS staff in the team on site
To assist and in some cases run internal projects when back in the ITS office to bring about the changes required.
Effective Communication is one of the main features of any role, and as a Senior Project Engineer you will be the key point of contact for the customer on a daily basis ensuring that all questions are answered quickly and that all incoming information is distributed to the team using the agreed methods.
You will need to ensure that all Team members, suppliers and customers are aware of what is required of them at all times and have all the information that they need to carry out their work effectively.
You will ensure that the Project Manager, customer Manager and suppliers are aware of any issues that arise in a timely manner so that they can deal with said issues
To run project meetings to discuss project progress and technical matters on projects
Where required issue weekly and monthly reports to customers with updated Project Gantt charts or other plans
- Modify, review and create Validation Documents, Quality Plans, Specifications, Test Specifications, Validation Reports
- Carry out Assessments of computerised systems to ensure that specifications and current regulations are met.
- Keep abreast of current Computer Validation related regulations
- Carry out system testing against specifications, record test results and review test results in line with current validation regulations.
- Work within the regulations required for Pharmaceutical projects and manufacturing, e.g. GMP, GAMP.
Summary of Technical Capabilities / Competencies:
You will have working knowledge in Validation in one or more of the following areas (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).
Typical regulatory knowledge would be in :-
- cGMP and GxP,
- FDA 21 CFR Part 11
- Annex 11
- Data Integrity