Validation Engineer

Position description

• Execute and support qualification and validation activities including:
• IQ/OQ/PQ protocols
• Cleaning validation
• Computer system validation (CSV)
• Utility and facility qualification
• Prepare, review, and approve validation documentation, protocols, reports, risk assessments, and deviations.
• Coordinate validation activities with internal departments and external vendors.
• Support commissioning and startup of new manufacturing equipment and systems.
• Ensure compliance with GMP requirements and company quality standards.
• Participate in change control, CAPA, and deviation investigations related to validated systems.
• Maintain validation master plans and lifecycle documentation.
• Assist during regulatory inspections and customer audits.
• Drive continuous improvement initiatives within validation and engineering processes.

Expectations for the new colleague

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related technical field.
• Strong technical writing and documentation skills.
• Ability to manage multiple projects and work independently.
• Excellent communication and teamwork skills.
• Experience with GMP validation in a regulated industry (advantage).
• Knowledge of FDA, EMA, EU GMP, ISPE, and GAMP guidelines (advantage).
• Familiarity with biologics manufacturing processes and cleanroom operations is preferred.
• Experience in biologics CDMO or sterile manufacturing environments.
• Experience with single-use systems and upstream/downstream processing equipment.
• Understanding of data integrity and Annex 11 / 21 CFR Part 11 requirements (advantage).
• Proficiency in English and Lithuanian.

Company offers

• Competitive salary. Salary range for this position : 2500 EUR to 3000 EUR gross (before taxes).

The final offer depends on competence, qualifications and experience.

• Exposure to a cutting-edge biologics manufacturing environment.
• Opportunities for professional growth, career development in a state-of-the-art biotechnology setting.
• Innovative, hard-working and quality-driven, collaborative, supportive company culture.