Computer System Validation Consultant

Rephine Limited; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading consultancy in Life Sciences is seeking a remote CSV Consultant (L2) based in the UK. This role involves providing senior-level support to pharmaceutical clients, ensuring compliance with GMP and GxP standards. Ideal candidates should have over 5 years of validation and CSV project experience, excellent communication skills, and a degree in Life Sciences or Engineering. The position offers competitive compensation, flexible hours, and opportunities for professional growth in a dynamic team.

Benefits

Competitive Compensation

Work-Life Balance

Opportunities for Growth

Global Exposure

Dynamic Environment

Drive Digital Transformation

Qualifications

• 5+ years in validation and CSV projects in a regulated environment.
• Strong understanding of GMP, GxP, and regulatory standards.
• Experience in consulting or client-facing roles is a plus.

Responsibilities

• Lead and execute CSV and validation activities.
• Ensure compliance with GMP, GxP, and Data Integrity.
• Act as the main client contact for validation topics.
• Review and approve validation documentation.
• Guide and mentor junior consultants.
• Work with clients in a consultancy environment.
• Manage project timelines and deliverables.

Skills

Validation experience

GMP and GxP knowledge

Excellent communication skills

Problem-solving skills

Ability to work independently

Education

University degree in Life Sciences or Engineering

Tools

ERPs

eDMS

eQMS

LIMS

SCADA

EBRs

Pharmacovigilance systems

Job description

Join Rephine – CSV Consultant (L2) – Life Sciences (Remote, based in UK)

At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support Pharmaceutical, Biotech, and Medical Device supply chains globally.

We are looking for a Consultant (L2) – CSV to join our team remotely from the UK. This role is ideal for professionals with experience in validation and CSV projects who want to provide senior-level support to pharmaceutical clients, acting as a trusted consultant and technical reference.

Role Purpose

Provide senior-level support to pharmaceutical clients in CSV, validation, and potentially other GMP-related projects, ensuring compliance and delivering high-quality consultancy services.

Key Responsibilities

• Lead and execute CSV and validation activities (planning, risk assessments, IQ/OQ/PQ, reporting).
• Ensure compliance with GMP, GxP, and Data Integrity requirements.
• Act as the main client contact for validation topics.
• Review and approve validation documentation.
• Provide guidance and mentoring to junior consultants.
• Collaborate with client stakeholders in a consultancy environment.
• Manage project timelines and deliverables to meet client expectations.

Experience & Background

• 5+ years in validation and CSV projects in the pharmaceutical or regulated environment.
• Strong understanding of GMP, GxP, and regulatory expectations (EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5).
• Consulting or client-facing experience is a strong plus.
• University degree in Life Sciences, Engineering, or similar.

Soft Skills

• Excellent communication and interpersonal skills.
• Proactive, structured, and solution-oriented mindset.
• Ability to work independently in remote project setups.
• Comfortable working in multidisciplinary, multicultural teams.

What You Bring

• Experience leading and participating in CSV projects across systems like ERPs, eDMS, eQMS, LIMS, SCADA, EBRs, and pharmacovigilance systems.
• Ability to assess system compliance with global regulatory standards.

Why This Role is for You

• Excited to work with clients on critical projects from a remote location in the UK.
• Comfortable managing technical, regulatory, and client-facing responsibilities.
• Eager to learn and grow in a role exposing you to diverse systems and industries.

Why Choose Rephine

• Competitive Compensation: Salary reflects your experience, plus additional benefits.
• Work-Life Balance: Remote work, flexible hours, shorter Fridays.
• Global Exposure: Multicultural team across multiple countries.
• Dynamic Environment: Young, enthusiastic team where your ideas are valued.
• Opportunities for Growth: Career development, leadership opportunities, and continuous learning.
• Drive Digital Transformation: Work on projects using the latest technologies to optimize quality processes.

For over 20 years, Rephine has helped leading Life Sciences companies improve manufacturing quality processes. Join us to grow your career and make an impact in a fast-evolving, global company.