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Senior Validation Engineer (CSV)

Hyper Recruitment Solutions Ltd

England

On-site

GBP 50,000 - 65,000

Full time

3 days ago
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Job summary

A leading biotech company in the Oxfordshire area is looking for a Senior Validation Engineer to join their dynamic validation team. This exciting role offers the chance to ensure that facility equipment and computerized systems remain compliant with regulatory standards. As part of your responsibilities, you will coordinate with internal teams and external contractors, manage qualification protocols, and oversee data integrity assessments. If you have a relevant scientific or engineering degree and extensive experience in a cGMP environment, this is an excellent opportunity to make a significant impact within a forward-thinking organization.

Qualifications

  • Extensive industry experience in validation, engineering, or operations.
  • Working knowledge of GMP utilities and equipment.

Responsibilities

  • Establish and maintain validation plans for equipment qualification.
  • Write and execute qualification protocols and manage vendors.

Skills

Validation Engineering
cGMP Compliance
Data Integrity
Project Management
Qualification Protocols

Education

Relevant degree in Scientific or Engineering

Tools

GMP Utilities
Computerized Systems Validation (CSV)

Job description

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

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