Validation Specialist

Project overview

We are looking for an experienced Validation Specialist to join our team and take full ownership of the end-to-end validation process across our projects. We are seeking a candidate with solid technical knowledge and a strong understanding of laboratory systems and cloud environments.

What We Offer

Who We Are – in Brief

We are a leader in technology services for companies in regulated industries. We have delivered hundreds of projects for clients around the world and bring over 24 years of market experience, with a particular focus on areas such as life sciences, QA, validation, cloud systems, human capital management (HCM), and Salesforce.

Industry: We operate in the IT sector.

Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).

Required Skills and Experience

• Access to a benefits program: private medical care, sports card, and group insurance.
• English lessons with a dedicated teacher.
• Access to an extensive training library covering both soft and technical skills.
• Company events, competitions, and challenges.
• Leading and overseeing validation projects, and defining and maintaining a consistent validation approach.
• Coordinating the validation and quality area: planning and supervising testing, system acceptance, and the creation of quality documentation.
• Supporting data migration strategy, analyzing user requirements (URS), and mapping business processes.
• Managing risks and issues, and responding quickly and effectively to unexpected technical problems.
• Preparing, reviewing, and approving validation documentation.
• Regular collaboration with the project team and participation in project meetings.
• At least 2 years of experience working in a validation department.
• Commissioning, Calibration / Hot Loop Checks.
• Hands-on experience validating solutions based on the Dynamics 365 platform (D365 validation experience).
• Very good knowledge of regulations and regulatory requirements: EU GMP, FDA, and GAMP 5 guidelines.
• Knowledge of ALCOA+ principles.
• Practical knowledge of laboratory (QC) processes and experience implementing and validating LIMS-class systems.
• Understanding of cloud architecture and the specifics of validating SaaS systems, with particular emphasis on the Veeva Vault platform.

Nice to have

• Knowledge of cleaning validation.

Project details

• Start: ASAP
• Remote: hybrid
• Location: Remote, Warszawa, Berno, Budapest, Vienna, Berlin, PL
• Languages: English