Utilities à United States

14505Permanent £50,000 - £65,000 Site Based Oxfordshire, United Kingdom Updated on: 14-04-2025

ROLE OVERVIEW

A leading biotech company based in the Oxfordshire area is seeking a dedicated Senior Validation Engineer. This role offers the chance to be part of a dynamic validation team, ensuring that facility equipment, utilities, instrumentation, and computerized systems are maintained in a validated state in line with regulatory guidance. As the Senior Validation Engineer, you will coordinate with internal customers and external contractors to manage qualification protocols and reports, project manage CQV campaigns, and support data integrity assessments.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Validation Engineer will be varied; however, the key duties and responsibilities are as follows:

1. Establish, revise, and maintain validation plans and procedures for equipment qualification to ensure cGMP compliance.
2. Write and execute qualification protocols and generate reports, including acceptance criteria.
3. Coordinate scheduling, execution, and review of qualification protocols and reports, and manage vendors and contractors performing qualification activities.
4. Manage projects related to computerized equipment and computer system validation (CSV) and perform data integrity assessments.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Senior Validation Engineer, we are looking to identify the following on your profile and past history:

1. Relevant degree in Scientific, Engineering, or a similar subject.
2. Extensive industry experience in validation, engineering, or operations within a cGMP environment.
3. A working knowledge and practical experience with GMP utilities, equipment, DIA, and CSV.

Key Words: Senior Validation Engineer / Biotech / Validation / cGMP / CQV / DIA / CSV / Qualification Protocols / Equipment Compliance / Data Integrity