VALIDATION ENGINEER
2300-2500
€/mon.
Gross
Į rankas per mėn.
Vilnius
- NORTHWAY ĮMONIŲ GRUPĖ
Job description
- Perform periodic and change control related re-qualification activities;
- Prepare, execute, review and approve internal qualification protocols for facility infrastructure systems and equipment;
- Coordinate, assist and document outsourced qualification activities;
- Prepare and update qualification and validation SOPs;
- Participate in process, cleaning and/or analytical method validation activities;
- Draft, review and approve other qualification, validation and GxP compliance related documents;
- Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's;
- Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to qualification and validation activities.
Requirements
- Minimum of a Bachelor's degree in the field of mechanical/ automation/ electronics/computer or other technical engineering;
- Experience in preparation and ability to read and interpret technical functional specifications, technical drawings, electrical schemes, technical manuals and similar documents;
- Experience in validation, maintenance or quality assurance preferred;
- Attention to details,
- Ability to identify deviation root cause effectively, efficient problem solving skills;
- Ability to function independently or in a cross-functional team
- Experience in GxP preferred;
- Fluent English language skills (verbal and written).
Salary
2300-2500 €/mon. gross
NORTHWAY ĮMONIŲ GRUPĖ
Northway Biotech is a leading Contract Development and Manufacturing Organization (CDMO) located in Vilnius, Lithuania, EU and Waltham, MA, USA. Extensive expertise in drug substance and drug product development, as well as GMP compliant manufacturing, makes us exceptionally well-versed in all aspects of the biopharmaceutical value chain – from gene to drug manufacturing in microbial and mammalian expressions systems. Our customers appreciate our ability to react rapidly to unexpected project changes, adjusting timelines, and availability of additional capabilities to meet our customers' evolving needs. We are deeply invested in providing high-quality, world-class contract development and manufacturing services with vast flexibility and responsiveness backed by a strong foundation in science and technology innovation.
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