GMP Lab Analyst | CSV Consultant

Rephine; Barcelona; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Annual bonus

Hybrid work

Travel for client sites

Birthday card

Team building events

Global project exposure

Job summary

Rephine, a leading Life Sciences quality consultancy, seeks an L3 CSV Consultant to support validation of computerised systems in GMP environments. You will bring hands-on laboratory experience and regulatory know-how to client projects across pharmacy, biotech and medical devices sectors.

You will work with a senior CSV Director and a team of experts, expanding your expertise in GAMP 5, 21 CFR Part 11, and data integrity while delivering on-site and remote validation activities across Europe.

Qualifications

• Must have hands-on GMP/GxP lab experience and regulatorily compliant practice.
• Experience with laboratory instruments (HPLC, spectrophotometers, balances) and related software.

Responsibilities

• Contribute to validation of computerised systems in GMP environments (LIMS, ELN, lab instruments, analytical software).
• Prepare and review validation documents (VMPs, URS, IQ/OQ/PQ protocols, traceability matrices, validation reports).
• Apply GMP knowledge to ensure systems meet regulatory standards.
• Support deviation management, change controls and CAPA activities.
• Collaborate with client labs, QA and IT to gather requirements and deliver on schedule.
• Participate in client meetings and on-site lab visits as part of project delivery.
• Develop knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity.

Skills

GMP/GxP knowledge

CSV/validation

Laboratory experience

LIMS/ELN familiarity

English & Spanish fluency

Education

Bachelor's degree in Pharmacy/Biotech/Chemistry/Bioengineering or related Life Sciences

Tools

LIMS

ELN

Instrument software

Job description

Join Rephine: Leading Life Sciences Quality Worldwide

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

Who We're Looking For:

Are you a pharmaceutical or analytical laboratory professional with GMP experience looking to take your career into CSV consulting? Do you have hands‑on experience operating laboratory equipment and working under quality standards in a regulated environment? If you are ready to grow into computerised system validation in a global consultancy that invests in its people, we want you as our next GMP Lab Analyst & CSV Consultant (L3).

Your Role:

As an L3 CSV Consultant, you will contribute to validation projects in GxP‑regulated environments, applying your pharmaceutical laboratory knowledge to support the validation of computerised systems used in lab and manufacturing settings. You will work alongside experienced consultants who will guide your development while you build your CSV expertise.

Key Responsibilities:

• Contribute to the validation of computerised systems used in pharmaceutical laboratory environments (LIMS, ELN, laboratory instruments, analytical software)
• Prepare and review validation documentation including VMPs, URS, IQ/OQ/PQ protocols, traceability matrices and validation reports
• Apply your GMP laboratory knowledge to understand system requirements and ensure they meet regulatory standards
• Support deviation management, change controls and CAPA activities
• Collaborate with client laboratory teams, QA and IT to gather requirements and deliver validation activities on schedule
• Participate in client meetings and on‑site laboratory visits as part of project delivery
• Actively develop your knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity guidelines.

What We're Looking For:

• Minimum 1 year of hands‑on experience working in a pharmaceutical, biotech or analytical laboratory under GMP or GxP standards — you have operated laboratory equipment, followed regulated protocols and understand how a compliant lab works
• Experience with laboratory instruments such as HPLC, spectrophotometers, balances, autoclaves or similar analytical equipment
• Familiarity with laboratory systems such as LIMS, ELN or laboratory software — as a user or administrator
• A degree in Pharmacy, Biotechnology, Chemistry, Biomedical Engineering or a related Life Sciences field
• Strong attention to detail and documentation skills developed in a regulated environment
• Fluency in Spanish and English — both written and spoken
• Valid driver’s license and willingness to travel to client sites when required
• Genuine interest in computerised system validation and digital transformation in pharma

Why This Role Could Excite You:

• Transition from the GMP laboratory into one of the most in‑demand technical profiles in Life Sciences — CSV consulting
• Learn from a CSV Director with 25 years of experience and a team of experts who will invest in your growth
• Work across multiple pharma clients and laboratory environments — building expertise faster than you would in a single company
• Grow towards L2 and beyond with a clear, structured career path

Why Choose Rephine?

• Competitive salary aligned to your experience, with annual bonus linked to company objectives
• Hybrid model if based in Barcelona / Remote for EU‑based profiles
• Occasional travel to client sites and Barcelona office
• Birthday gift card and Summer Relax flexibility
• 2 team building events per year
• International project exposure across Spain, UK and Europe
• Structured onboarding with dedicated internal trainers
• A team where people stay — 10, 20 and even 30 years