Senior Validation Engineer (North West - Warrington)

Senior Validation Engineer (North West – Warrington)

Job Description

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.

Applicants must have the presence to promote the company image and ensure that this is enhanced by successful implementation of systems. This role offers opportunities for professional growth and development, with appropriate training provided as needed to align with business requirements.

On some projects, you will be working independently on customer sites, building strong relationships with clients and internal staff. A positive attitude and willingness to extend your skill set are essential, as you will be expected to take on new challenges and contribute to the company\’s growth and reputation.

As part of a team, you will collaborate to deliver projects on time, within budget, and to the required quality standards, adhering to the ITS/Client Quality Management System. You will also mentor junior staff members and be involved in their development, producing and reviewing project documentation such as design documents and test specifications.

Minimum Requirements

1. At least 5 years of experience in validation (computerised systems, equipment, processes and projects) 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. Demonstrated understanding and hands-on experience generating and reviewing validation lifecycle documents.
4. Strong interpersonal skills, excellent review and analytical skills.
5. Strong commitment to customer service and satisfaction.
6. Capable of building and maintaining strong client relationships.
7. Strong written and verbal communication skills.
8. Self-motivated and a quick learner of business processes and technologies.
9. A working knowledge of pharmaceutical, biotech, and medical device production processes.
10. Ability to discuss technical aspects of validation and GxP testing with clients.
11. Strong attention to detail regarding documentation.
12. Well-organised and capable of working effectively within a multi-disciplinary team.
13. Knowledge of emerging trends in validation and regulatory compliance.
14. Experience with specific validation tools or software (particularly EDMS, EQMS or paperless validation).
15. Experience in mentoring or leading teams.
16. Additional certifications in validation or related fields.
17. Experience of Cleaning Validation or Analytical Method Validation.
18. Project Management.

Additional Info

1. At least 5 years of experience working in the Life Sciences Industry.
2. Ability and willingness to maintain knowledge of regulations.
3. Applicants must be able to communicate effectively both formally and informally, orally and in written English.
4. Driving Licence.

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. A significant number of our people have been with ITS for 10 or more years.

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