Senior Validation Engineer

As Senior Validation Engineer you will manage, directly implement, execute, and support the validation of activities carried out at Sanobiotec, while ensuring they are harmonized with regulatory and company requirements.

Specific Responsibilities Include:

• Support for all aspects of the validation life cycle
• Developing, reviewing, approving, and managing GMP system lifecycle documentation including validation plans, user requirements (URS), FAT/ SAT, validation protocols (IQ/OQ/PQ), validation reports, SOP, change control documentation, risk assessments, validation deviations and qualification summary reports
• Generation and technical reviews of standard operational procedures for validation activities
• Supervision of contractors when executing qualification projects
• Working with other departments to troubleshoot equipment, process and validation issues such as deviation impact assessments and root cause analysis
• Performing all job responsibilities and ensuring compliance with current U.S. and EU GMP regulations
• Acting as validation SME during internal, external and regulatory audits
• Providing leadership and guidance to team members on qualification/ validation-related issues

• BSc/ MSc degree in engineering, life sciences
• At least five years’ experience in quality assurance engineering in the pharmaceutical, biotech or medical device industry or experience in related engineering areas
• Extensive knowledge of Good Manufacturing Practices (GMP), validation and qualification, regulatory guidelines
• Demonstrated awareness of validation including but not limited to facilities, utilities, equipment, computer system validation, equipment and systems qualification (DQ/IQ/OQ), HVAC, cleanroom qualification
• Ability to work independently or within a team and on multiple projects, with flexibility to adapt to changing priorities
• Technical expertise with excellent written and oral communication and interpersonal skills
• Fluent English and Lithuanian
• Proficiency with MS Word, Excel, and Power Point
• Technical writing and strong documentation skills

• A chance to become part of a growing, determined, and innovative team
• A vibrant and comfortable working environment
• Professional development opportunities
• Team support