Senior Validation Engineer

Senior Validation Engineer (North East - Middlesbrough)

Job Overview

The work will be varied and challenging, offering opportunities to develop both technical and interpersonal skills. As a Validation Engineer, you will play a crucial role in ensuring that utilities/facilities, equipment, computerised systems, manufacturing processes and packing operations meet operational requirements and GMP regulatory standards.

You will be responsible for validating systems to meet the expected operational and GMP regulatory requirements, ensuring compliance with FDA, MHRA and/or ISO standards within both the pharmaceutical, biotech and medical device industries.

Responsibilities

1. Validate systems to meet operational and GMP regulatory requirements.
2. Ensure compliance with FDA, MHRA and/or ISO standards.
3. Promote the company image and enhance it through successful implementation of systems.
4. Work independently on customer sites, building strong relationships with clients and internal staff.
5. Collaborate with team members to deliver projects on time, within budget, and to the required quality standards.
6. Mentor junior staff members and be involved in their development.
7. Produce and review project documentation such as design documents and test specifications.

Minimum Requirements

1. At least 5 years of experience in validation within the pharmaceutical, biotech, or medical device industries (FDA/MHRA regulated).
2. Strong knowledge of GxP/cGMP and GAMP with understanding of FDA 21 CFR Part 11 and Annex 11 regulations.
3. Hands-on experience generating and reviewing validation lifecycle documents.
4. Strong interpersonal skills and commitment to customer service.
5. Ability to discuss technical aspects of validation and GxP testing with clients.
6. Strong attention to detail regarding documentation.
7. Experience with specific validation tools or software (particularly EDMS, EQMS or paperless validation).
8. Experience in mentoring or leading teams.
9. Driving Licence.

Additional Info

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 engineers 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.

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

Holidays up to 25 days; additional holidays are awarded for long service.

Enrolment into Pension after 3 months and health care is available after 12 months' service.

The Company

Industrial Technology Systems Ltd (ITS) started trading in 1991 so with over 30 years' history you can see we are a stable company with a significant history to call upon. We are an Engineering company, owned and run by Engineers, with a strong long-term development strategy and a proven track record in good business acumen.