Senior Validation Specialist- Computer System Validation

Regeneron Pharmaceuticals, Inc; Cambridge; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading life sciences company in Cambridge seeks a Senior Validation Specialist to ensure compliance of computerized systems with regulatory requirements. The ideal candidate has over 5 years of experience in a pharmaceutical setting, strong communication skills, and the ability to work collaboratively. Responsibilities include planning validation activities, generating documentation, and supporting regulatory audits.

Qualifications

• 5+ years of relevant work experience in a pharmaceutical or biopharmaceutical manufacturing facility.
• GMP experience is required.
• Experience with GxP-regulated computerized systems and analytical instruments.

Responsibilities

• Plan and drive all CSV activities to maintain quality compliance.
• Generate and review qualification and validation protocols.
• Maintain validation documentation including plans and assessments.
• Support inspections and audits with validation documentation.

Skills

Excellent verbal and written communication skills

Improvement of processes

Team collaboration

Flexibility with shifting priorities

Education

BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences

Tools

ERP

LIMS

QMS

Job description

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Senior Validation Specialist- Computer System Validation, Cambridge

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Client:

Location:

Cambridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

65da941f38f1

Job Views:

9

Posted:

12.08.2025

Expiry Date:

26.09.2025

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Job Description:

We are seeking a highly skilled, self-motivated Senior Validation Specialist- CSV to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part of Regeneron Cell Medicines (RCM), a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part 11, GAMP 5, and Annex 11.

As a Senior Validation Specialist, a typical day might include:

Planning and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM.

Generating, carrying out, and reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Creating and maintaining validation documentation, including Validation Plans, Risk Assessments, Test Scripts and Reports.

Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation to ensure compliance within the operation.

Supporting regulator’s inspections and audits by providing validation documentation and explanations and communicates company’s computer validation policies.

Generating, reviewing, editing, and approving change controls, impact assessments, SOPs, reports, as well as deviation notifications/investigations

Collaborating with IT, Automation, Quality Assurance and End Users to ensure system compliance as well as with outside contractors/vendors to complete validation tasks

Managing contingent workers as needed

This role might be for you if you:

Have excellent verbal and written communication skills

Are continuously driving for improved processes for more efficient performance

Have the ability to work collaboratively as a part of a team

Can be flexible with shifting priorities

In order to be considered for this role, you must have at least a BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+ years of relevant work experience. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility; GMP experience is required. Experience with ERP, LIMS, QMS and other GxP-regulated computerized systems and analytical instruments is required.