Process Validation Specialist

QCS Staffing; England; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading Biopharma client in the UK seeks a Process Validation Specialist for a 12-month contract. The role encompasses leading process validation activities in cell and gene therapy manufacturing. Candidates should have a proven track record in process validation and regulatory compliance, with hands-on experience in authoring necessary documentation. This is an excellent opportunity to contribute to cutting-edge projects while establishing yourself as a vital team member in a dynamic environment.

Qualifications

• Proven track record in process validation and process performance qualification (PPQ).
• Hands-on experience authoring validation documentation.
• Familiarity with regulatory requirements for process validation.
• Cell and gene therapy or biologics experience preferred.

Responsibilities

• Lead and execute process validation activities for cell and gene therapy.
• Develop and author process validation documentation.
• Conduct ancillary validation studies such as hold time verification.
• Ensure compliance with regulatory requirements for process validation and PPQ.
• Collaborate with cross-functional teams to support process characterization and control strategy development.

Skills

Process validation

Cell and gene therapy

GMP manufacturing

Validation documentation

Regulatory compliance

Education

Bachelor's degree in Life Sciences

Tools

GxP Systems

Job description

Overview

Process Validation Specialist - Oxfordshire, UK - 12 Month Contract

Are you a Process Validation Specialist professional with experience in Cell & Gene therapy? Are you looking to take the next step in your career and be part of an exciting new project? Then the position of process validation specialist is exactly what you’re looking for.

This is your chance to work for a company that is a pioneer in gene and cell therapy focussing on long-term curative treatments. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member.

Led by an experienced executive team, this is a fantastic opportunity to work for a high-profile Biopharma client.

Responsibilities

Essential Duties and Responsibilities for this x role include, but are not limited to, the following:

• Lead and execute process validation activities for cell and gene therapy manufacturing processes.
• Develop and author process validation documentation.
• Conduct ancillary validation studies (e.g., hold time validation, mixing studies, sterile filter validation).
• Ensure compliance with regulatory requirements for process validation and PPQ.
• Collaborate with cross-functional teams to support process characterization and control strategy development.

Desirable Experience

• Proven track record in process validation and process performance qualification (PPQ) within GMP manufacturing environments.
• Hands-on experience authoring validation documentation.
• Familiarity with regulatory requirements for process validation.
• Experience conducting ancillary validation studies.
• Prior exposure to cell & gene therapy or biologics preferred; small molecule experience acceptable.