CSV Consultant ( Barcelona, Spain)

PharmaX Solutions; Barcelona; On-site; EUR 45,000 - 65,000; Full time

Job summary

PharmaX Solutions is seeking a CSV Consultant to join our team in Barcelona, Spain. You will work closely with clients to ensure computerized systems meet GxP and regulatory requirements, performing CSV activities and supporting audits.

The role emphasizes data integrity, ALCOA+ principles, and collaboration with cross-functional teams to deliver practical compliance solutions in life sciences projects.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in CSV activities and validation.
• Knowledge of GxP regulations and guidelines (FDA, EU, ICH).
• Familiarity with documentation practices and ALCOA+.
• Experience with validated systems like TrackWise, Veeva Vault or similar.

Responsibilities

• Performing CSV activities and validation tasks in client projects.
• Ensure compliance with GxP regulations and industry standards.
• Support data integrity and ALCOA+ principles across systems.
• Prepare for and assist regulatory audits and inspections.
• Identify and manage validation and compliance risks.
• Support and improve Quality Management Systems (QMS).
• Collaborate with clients, technical, quality and business teams.
• Prepare and review validation and compliance documentation.

Skills

CSV knowledge

GxP compliance

Data integrity (ALCOA+)

Audits & inspections

Communication

Project management

Excel

Analytical thinking

Client collaboration

English (B2)

Education

Bachelor's degree in Life Sciences/Chemistry/Pharmacy/Biotechnology/IT/Engineering

Tools

TrackWise

Veeva Vault

ValGenesis

HP ALM

KNEAT

SAP

LIMS

MES

Job description

We’re Hiring: CSV Consultant | PharmaX Solutions | Location: Barcelona, Spain

Are you passionate about Computerized System Validation (CSV), GxP compliance and data integrity? Do you enjoy working directly with clients and solving complex challenges in the life sciences industry?

PharmaX Solutions is looking for a CSV Consultant to join our growing team and work on exciting projects across the pharmaceutical and life sciences sector.

What you’ll do

As a CSV Consultant, you will work closely with clients and cross-functional teams to ensure that computerized systems and processes meet applicable GxP and regulatory requirements.

Your responsibilities will include:

• Performing Computerized System Validation (CSV) activities
• Ensuring compliance with GxP regulations and industry standards
• Supporting data integrity and ALCOA+ principles
• Preparing for and supporting regulatory audits and inspections
• Identifying and managing compliance and validation risks
• Supporting and improving Quality Management Systems (QMS)
• Working with clients to understand their needs and develop practical compliance solutions
• Collaborating with technical, quality and business teams
• Preparing and reviewing validation and compliance documentation

What we’re looking for

You bring 1–5 years of experience in one or more of the following areas:

• Computerized System implementation, Validation and change control
• Validation of complex systems such as MES, SAP, LIMs.
• GxP-regulated environments

You should also have:

• Good knowledge of GxP regulations and guidelines, including FDA 21 CFR Parts 11, 210 & 211, EU GMP, ICH, GAMP 5 and ISPE
• Understanding of Good Documentation Practices (GDP) and ALCOA+ principles
• Experience or familiarity with GxP systems such as TrackWise, Veeva Vault or similar platforms
• Familiarity with validation tools such as HP ALM, KNEAT or ValGenesis
• Good working knowledge of Microsoft Office, particularly Excel, Word and PowerPoint
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to manage multiple projects and priorities
• A collaborative, proactive and client-focused mindset

Education

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biotechnology, IT, Engineering or a related field

Languages

English: Strong working/technical proficiency (minimum B2 level)

Why PharmaX?

At PharmaX, you’ll have the opportunity to:

• Work on real-world projects within the pharmaceutical and life sciences industry
• Collaborate with international clients and cross-functional teams
• Develop your expertise in GxP, CSV, validation and digital compliance
• Work in a growing and collaborative environment
• Make a direct impact on quality, compliance and patient safety

If you're ready to take the next step in your CSV/GxP career, we’d love to hear from you.