CSV Project Manager

PQE Group; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading consulting firm in pharmaceuticals in Barcelona is looking for a CSV Project Manager to lead validation projects and ensure compliance with industry regulations. The ideal candidate will have at least 5 years of experience in the pharmaceutical sector and a degree in relevant fields. Fluent Spanish and English are required. This full-time position offers a dynamic, multicultural work environment and opportunities for international projects.

Servicios

Opportunities to work on international projects

Challenging and multicultural work environment

Formación

• At least 5 years of experience in the Pharmaceutical sector.
• In-depth knowledge of GxP regulations and 21 CFR Part 11.
• Experience in managing validation protocols and risk assessments.

Responsabilidades

• Manage Computer System Validation (CSV) projects ensuring compliance.
• Develop CSV strategies and plans for various application systems.
• Conduct risk assessments and develop mitigation strategies.
• Review documentation and perform tests during validation.
• Provide regulatory consulting on CSV requirements.
• Collaborate with IT and Quality Assurance teams.
• Train and support junior consultants on CSV.

Conocimientos

GxP regulations knowledge

Risk assessment

Technical documentation

Cross-functional collaboration

Fluent Spanish

Fluent English

Educación

Bachelor’s or Master’s degree in Pharmaceutical/Industrial disciplines

Herramientas

Validation software

Test management tools

Descripción del empleo

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees across Europe, Asia, and the Americas.

Due to ongoing growth, we are looking for a CSV Project Manager to join our team in Barcelona, Spain.

Responsibilities include, but are not limited to:

• Management of Computer System Validation (CSV) projects: Leading and executing CSV projects, ensuring compliance with GxP regulations, 21 CFR Part 11, and other relevant regulations.
• Development of CSV strategies and protocols: Creating and implementing strategies, plans, and validation protocols (IQ/OQ/PQ) for laboratory, manufacturing, and enterprise application computer systems.
• Risk assessment and mitigation: Conducting risk assessments and developing mitigation strategies for computer systems.
• Conducting validation activities: Reviewing documentation, performing tests, and managing deviations during validation activities.
• Regulatory consulting in the CSV field: Providing expert advice on regulatory requirements and industry best practices for computer system validation.
• Cross-functional collaboration: Working closely with IT, Quality Assurance, and Regulatory Affairs teams to ensure project success.
• Training and mentoring: Training and supporting junior consultants and client personnel on CSV principles and practices.

Requirements:

• Degree: Bachelor’s or Master’s degree in Pharmaceutical/Industrial disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).
• Experience: At least 5 years in the Pharmaceutical sector.
• Regulatory knowledge: In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, EU GMP, and other relevant guidelines.
• Languages: Fluent written and spoken Spanish and English (at least B2 level).
• Technical skills: Familiarity with key validation software, test management tools, and computer systems.
• Technical documentation: Experience in managing validation protocols, reports, and risk assessments.

Location: Barcelona, Spain

Next Steps

Upon receiving your application, our Recruiting department will contact you for an initial HR interview if a match is found.

If successful, a technical interview with the Hiring Manager will be scheduled.

If the outcome is positive, the recruiter will contact you to discuss further steps or our proposal.

If not, we will inform you that the process has been halted.

Working at PQE Group

As part of PQE, you will work in a challenging, multicultural environment that values collaboration and innovation. PQE offers opportunities to work on international projects, enhance your skills, and interact with colleagues worldwide.

If you seek a rewarding and exciting career, PQE Group is the place for you.

Apply now and take the first step toward an exciting future with us.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Consulting, Engineering, and Quality Assurance

Industries: Business Consulting and Services

Referrals can double your chances of an interview at PQE Group. Sign in to set job alerts for “Project Manager” roles.