Job ID :
Lithuania - Vilnius
- Manage and conduct excel spreadsheet pre-validation and validation
- Establish philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures
- Manage protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation
- Review and approve facility equipment and software changes, evaluate and determine required validation testing
- To identify and support creation of best practices, to provide training and constructive input to team members.
- To solve problems in complicated situations through analytical skills, creativity and judgment.
- University degree in bioengineering, biotechnology, chemical engineering, chemistry, biochemistry.
- Experience in manufacturing, equipment maintenance and supervision; awareness of products characteristics.
- Fluent English (essential).
- Knowledge of established Quality Management Systems, ISO 13485 regulations.
- Excellent computer skills (Microsoft Office).
- Ability to lead, direct and manage cross-functional teams and get results through others. Excellent communication skills, including writing, articulating, listening, and questioning skills required.
- Team player and team builder.
- Attention to detail, accuracy, diligence and responsibility.