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Validation Manager

Remote, Sant Cugat del Vallès·Added 2 days ago (last checked 6 Nov)

Ambit Iberia

15 open roles

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Our summary

Hours: Monday to Friday
Work mode: Remote (Sant Cugat del Vallès)
Experience: 3+ years
Education: University degree
Benefits: Private health insurance, flexible pay plan

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Skills

Requirements

What we're looking for

Bachelor's degree in Information Technology, Healthcare, Life Sciences, or a related field.
Strong knowledge of Computer System Validation (CSV) principles and methodologies.
Expert understanding of regulatory frameworks and guidance, including:
- FDA 21 CFR Part 11
- EU GMP Annex 11
- GxP requirements and validation best practices
Experience preparing and maintaining validation documentation in regulated environments.
Solid understanding of validated IT systems, including software, infrastructure, and system integrations.
Strong analytical, documentation, and stakeholder management skills.

Nice to have

More than 3 years of experience in Computer System Validation within the pharmaceutical, biotechnology, or life sciences industry.
Experience supporting complex data management, digital transformation, or enterprise applications.
Previous exposure to audit and inspection readiness activities.
Experience working within global, cross-functional teams.

SCHEDULE 🕘:

08h-17h from Monday to Friday (flexible)
Full remote

CONDITIONS 🌱:

Salary package based on your profile.
Permanent contract
Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.
Discounts in gym network.
Training catalogue.
Referral program

Our goal is that you are well in every way!

The role

📍 Hybrid | Pharmaceutical Industry

Are you passionate about Computer System Validation (CSV) and ensuring compliance in regulated environments? We are looking for a Validation Manager to lead validation activities for a strategic Holistic Data Management (HDM) initiative within a global pharmaceutical environment.

What you'll do

As Validation Manager, you will be responsible for ensuring that the system meets all applicable validation and compliance requirements throughout its lifecycle.

Own and coordinate all validation activities for the system.
Prepare, review, and maintain validation documentation, including Validation Plans, Test Documentation, Traceability Matrices, Validation Summary Reports, and related records.
Lead qualification activities across QA and Production environments, ensuring release readiness.
Coordinate validation testing activities, deviation management, and defect resolution.
Ensure compliance with CSV, GxP, GLP, and applicable validation standards.
Review and support SOPs, AAPs, training materials, and operational documentation required for go-live.
Collaborate with Business stakeholders, IT System Leads, Quality Assurance, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities.
Act as a key compliance partner during audits, inspections, and system lifecycle activities.

About Ambit Iberia

Ambit Iberia is a specialized consultancy providing IT and engineering services to the pharmaceutical and life sciences sectors, with a strong focus on regulated environments. The company supports clients with digital transformation, data integrity, and compliance-driven projects, offering services such as system validation, MES engineering, cybersecurity, and cloud-based software development. Operating primarily in Spain and Portugal, Ambit Iberia positions itself as a niche partner for pharma companies seeking technical expertise in highly regulated settings.

With its main office in Barcelona, Ambit Iberia serves as the Spanish arm of a broader international group, delivering projects across Europe. The company's work culture emphasizes technical excellence and regulatory compliance, making it an attractive option for international professionals with backgrounds in pharma IT, validation, and engineering. Many roles are offered as fully remote or hybrid, allowing flexibility for candidates based in Spain or Portugal, and the company actively seeks talent with experience in GxP environments and modern cloud technologies.

Industry: Health
Employees: 160
Headquarters: Barcelona, Spain
In Spain: Barcelona

Good to know if you are moving

Ambit Iberia offers fully remote positions for some roles, allowing flexibility for international professionals based in Spain or Portugal.
The company specializes in the pharmaceutical sector, providing opportunities to work on regulated systems and compliance-driven projects.
Barcelona, where Ambit Iberia is based, is a major European hub for life sciences and technology, offering a vibrant professional community.
Roles often require expertise in GxP, MES, and cloud technologies, making it a good fit for specialists in pharma IT and engineering.
The company's international group structure may offer opportunities for cross-border collaboration and career growth.

All open roles at Ambit Iberia