Remote Validation Engineer — CSV/GAMP Specialist

PTT CONSULTING sp. z o.o.; Poland; On-site; PLN 120,000 - 180,000; Full time

Job summary

PTT CONSULTING sp. z o.o. seeks a Validation Engineer to support a U.S. market project focused on development and testing of manufacturing systems to improve product and process quality.

The role involves working on technical standards, documentation, and validation activities with limited supervision. Partial availability in the U.S. time zone is required and the candidate should have experience with CSV/GAMP, GxP, and external suppliers.

Qualifications

• University degree in technology, science, engineering, or a related field.
• Substantial experience in computerized system validation (CSV/GAMP) or similar validation activities.
• Knowledge of GAMP 5, V-model, and GxP (Good x Practices).
• Strong expertise in working with external suppliers and third parties.
• Familiarity with non-conformities and deviations (implementation will follow client guidelines).
• Basic understanding of quality management principles.
• Fluent in written and spoken English.
• Strong communication skills and ability to work independently.

Responsibilities

• Creation of quality documents: Test Plan, Test Report, deviations.
• QA review of pre-executed and post-executed tests (Installation Verification, Installation Operational Qualification, Data Migration, Integration Test, Configuration Test, Functional Test, User Acceptance Test), regarding compliance with internal procedures and approved validation standards.
• Participation in the development / improvement of QMS procedures and practices for data integrity / CSV as it relates to the area of responsibility.
• Coordination of validation activities during project or run and support.
• CSV support for several affiliates in different time zones.
• Advise Validation Lead, Project manager and Service Manager for validation activities and workload to ensure proper planning and workforce mobilization to carry out the activities.
• Train and coach on validation, practices related to CSV. Advise the business system owner on the fit for purpose of the system and provide input to release the system for use by the business.

Skills

CSV/GAMP

GAMP 5

V-model

GxP

Supplier management

Quality management

English

Education

University degree in technology, science, engineering, or related field

Tools

JIRA

Confluence

Job description

PTT CONSULTING sp. z o.o. seeks a Validation Engineer to support a U.S. market project focused on development and testing of manufacturing systems to improve product and process quality.

The role involves working on technical standards, documentation, and validation activities with limited supervision. Partial availability in the U.S. time zone is required and the candidate should have experience with CSV/GAMP, GxP, and external suppliers.