VQ Life Sciences are recruiting for a Permanent CSV Engineer in the Northwest for someone with experience in Pharmaceutical/Medical Device/Biotech industry.
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.
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
Identify training opportunities in self and others in the team on site
Assist and in some cases run internal projects when back in the 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.
Choice of the correct technical way forward to fulfil out the functions required in line with current regulation and customer requirements.
To assess supplier deliverables and verify whether they are acceptable to the customer based upon standards and specifications.
Choice of the correct person to carry out the tasks to resolve the issues, depending upon urgency, capabilities and training requirements.
Is the request made by the customer in or out of scope and how should we deal with that as a team.
Summary of Technical Capabilities / Competencies:
You’ll 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
Summary of Behavioural Capabilities / Competencies:
All of the companies staff are strong team players, honest, curious, passionate, and innovative people with a desire to accomplish amazing amounts of important work.
You will need to use good judgement to define the best solutions for the Project, the Customer and company.
You will need to understand the values by which we operate (our Company Values, skills and Behaviours) and operate within those to be someone who our staff and customers WANT to work with.
If you’re based in the Northwest and have recent CSV experience within the Pharmaceutical/Medical Device/Biotech industries, and would like to know more, apply here.