Validation Engineer
2500-3300 €/mon.
gross
CVbankas.lt calculator data.
Full-time
Vilnius
- NORTHWAY ĮMONIŲ GRUPĖ
Position description:
We are seeking a motivated and detail-oriented Validation Engineer to join our team.
The successful candidate will support qualification and validation activities for GMP manufacturing equipment, utilities, facilities, computerized systems, and processes used in the production of biologics products.
This role works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Automation, and Regulatory teams to ensure compliance with cGMP, FDA, EMA, and industry standards.
Execute and support qualification and validation activities including:
The successful candidate will support qualification and validation activities for GMP manufacturing equipment, utilities, facilities, computerized systems, and processes used in the production of biologics products.
This role works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Automation, and Regulatory teams to ensure compliance with cGMP, FDA, EMA, and industry standards.
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.
Requirements:
- 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).
Salary
2500-3300
€/mon.
gross
NORTHWAY ĮMONIŲ GRUPĖ
The Northway group of companies unites 17 companies operating in the fields of medicine, biotechnology, biopharmaceuticals, wellness and investment for more than 20 years. The biotechnology cluster, operating under the Northway Biotech brand, includes 7 companies: five of them in Lithuania, one each in the United Kingdom and the United States. In the latter market, Northway Biotech is the largest biotechnology investor from the Baltic region.
In total, more than 200 highly qualified specialists work in biotechnology companies. The companies provide services to international pharmaceutical and biotechnology companies, including companies publicly listed on European and US stock exchanges. The main export markets are Europe, North America and Asia. The group's scientists also cooperate with international scientific institutions, developing innovative biotechnology projects.
Northway Biotech is a member of the Lithuanian Consortium for Cooperation with the Massachusetts Institute of Technology (MIT), thus strengthening long-term scientific and industrial cooperation between Lithuania and the United States in the life sciences sector. The company was recognized for its leadership in the development and manufacturing of biologics with the prestigious Outsourced Pharma 2025 CDMO Leadership Awards in the global biologics CDMO category.
More about the company: www.northwaybiotech.com
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In total, more than 200 highly qualified specialists work in biotechnology companies. The companies provide services to international pharmaceutical and biotechnology companies, including companies publicly listed on European and US stock exchanges. The main export markets are Europe, North America and Asia. The group's scientists also cooperate with international scientific institutions, developing innovative biotechnology projects.
Northway Biotech is a member of the Lithuanian Consortium for Cooperation with the Massachusetts Institute of Technology (MIT), thus strengthening long-term scientific and industrial cooperation between Lithuania and the United States in the life sciences sector. The company was recognized for its leadership in the development and manufacturing of biologics with the prestigious Outsourced Pharma 2025 CDMO Leadership Awards in the global biologics CDMO category.
More about the company: www.northwaybiotech.com