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.