Careers > Validation Engineer - Warrington

Validation Engineer - Warrington

Validation Engineer

ITS is looking for a Validation Engineer to join its team in Warrington.

Responsibilities

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 ITS clients expect and in line with the ITS/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.

Essential Skills

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.

Staff Development

Our staff development ethos encourages team members to think laterally which results in better solutions for our customers.

We recognise that to be able to retain the best employees with up-to-the-minute skills, we need to invest in their development. We marry on-the-job experience with formal training and have an open management style – senior personnel are always available to discuss ideas.

Over 60% of our workforce has been with ITS for more than eight years which we believe demonstrates our commitment to good staff relations.

About ITS

Established in 1991, Industrial Technology Systems Ltd (ITS) is a friendly and supportive company that strives to be one of the best companies to work for. ITS is a place where everybody has the opportunity to make a significant difference.

ITS is an equal opportunities employer, committed to eliminating discrimination and encouraging diversity amongst its workforce, so we welcome applications from anyone and appoint staff purely on the basis of individual merit.

Career Progression

The opportunity to progress within the team will be available to the right candidates.

Partnerships

You will be part of a company that is committed to building long term relationships with customers, and responsible for maintaining support to the many clients we have worked with since the company was formed in 1991. ITS’ team strives to understand our clients’ needs and work closely with them to provide solutions that meet expectations and deliver. We strongly believe in getting to know our clients and their teams, and what their needs are so that we can form solid partnerships that deliver a win-win situation for both the customer and ITS.

Location

A position exists which is Warrington based. Travel will be expected to alternate office and client's sites.

Salary

The salary is competitive.

Interviews

All interviews will be held in the UK.

Working in UK

Entitlement to work in the UK is a necessity.

To Apply

To apply, please send a copy of your CV to vacancies@its-ltd.co.uk. With full named CV, salary expectations and eligibility to work in the UK.