IT Validation Consultant

Amaris Consulting | Part of Mantu; Barcelona; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Remote work options

Transit and restaurant tickets

Kindergarten support

Private health insurance

Annual personal budget

Job summary

Amaris Consulting is seeking an IT Compliance & CSV Specialist to drive validation of data pipelines and IT platforms in regulated environments. You will coordinate lifecycle activities from design through deployment, focusing on data integrity, risk mitigation, and audit readiness.

The role requires collaboration with IT, Quality, Manufacturing, and Supply Chain teams to ensure regulatory alignment and robust documentation.

Qualifications

• Extensive experience in Computer System Validation (CSV) and GAMP 5 frameworks.
• Proven experience in regulated environments (GxP) and IT.
• Experience ensuring IT systems and data pipelines comply with regulatory requirements.

Responsibilities

• Support IT System Leads to ensure validated data pipelines meet standards.
• Oversee lifecycle of data pipeline validation from design to deployment.
• Collaborate with cross-functional teams to define validation strategies for new systems.
• Coordinate validation activities across departments with timelines and quality expectations.
• Conduct risk assessments to identify gaps and define mitigation measures.
• Maintain audit-ready, traceable validation documentation.

Skills

CSV Validation

GAMP 5

Regulated Environments

Information Technology

Audit Preparation

Risk Assessment

Multiple Projects

Cross-functional Teams

Documentation Skills

English Proficiency

Job description

Take your career to the next level with Amaris Consulting as an IT Compliance & CSV Specialist - Data Pipelines & Platforms. Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment by planning the kickoff and follow up on projects. Join Amaris Consulting, where you can develop your potential and make a difference within the company.

WHAT WOULD YOU NEED?

• Solid experience in Computer System Validation (CSV), including frameworks and methodologies such as GAMP 5
• Extensive knowledge of regulated environments (e.g. GxP) and Information Technology
• Proven experience ensuring IT systems and data pipelines comply with regulatory requirements
• Experience in audit preparation and participation (internal and external)
• Strong background in risk assessment, including identification of validation gaps and definition of mitigation measures
• Ability to manage multiple validation projects simultaneously and work with tight deadlines
• Strong communication skills and ability to collaborate with cross-functional teams (IT, Quality, Manufacturing, Supply Chain, etc.)
• Excellent documentation skills and attention to detail
• Professional level of English (spoken and written); any additional language is a plus

WHAT WILL YOU DO?

• Support IT System Leads in ensuring that validated data pipelines within HP Operations domains (Manufacturing, Quality, Supply Chain Management, etc.) are fully compliant with legal, regulatory, and corporate standards
• Oversee the complete lifecycle of data pipeline validation, from design to deployment, with a strong focus on risk mitigation, data integrity, and audit readiness
• Collaborate with cross-functional teams to define validation strategies and plans for new software systems and data pipelines
• Coordinate and support validation activities across various departments, ensuring alignment with project timelines and quality expectations
• Conduct risk assessments to identify potential validation gaps and ensure appropriate mitigation measures are implemented
• Ensure that all validation activities adhere to relevant regulatory standards and internal compliance policies
• Maintain accurate, complete, and up-to-date validation documentation, ensuring traceability and inspection readiness
• Support IT System Leads in maintaining IT compliance for platform components, including:
  • Change control
  • Risk assessment
  • Configuration and installation testing
  • Functional and requirements testing
  • Periodic reviews and exception monitoring
• Contribute to audit preparation and participation, providing evidence and explanations related to validation and compliance activities

WHY US?

Join our dynamic team of talented individuals and experience a world of growth and opportunities. Here's what we offer:

• Grow rapidly with a tailored career path and salary evaluation. 70% of our senior leaders started at entry level.
• Enhance your skills through our Tech Academy catalog, Udemy E-learning Platform, Language Sessions, webinars, and workshops.
• Take charge of your training with an annual personal budget and company-paid certifications.
• Enjoy flexible policies, remote work options, and fantastic social benefits like transit and restaurant tickets, kindergarten support, and private health insurance.
• Benefit from our WeCare program, supporting employees in critical situations.
• Unleash your full potential, both professionally and personally.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.