Validation Manager (213148BR)

We are looking for Process Validation Manager who will be responsible for leading process validation activities in Vilnius Operations and managing a specialist team.

RESPONSIBILITIES:

Team management:

• Allocates the functions and tasks of the team members, sets individual performance targets, and monitors their implementation
• Proposes changes, prepares, adjusts of the validation process and approves documents in the Master Control system
• Participate and organizes trainings, validation trainings, and Good Manufacturing Practice (GMP) trainings.
• Plans, organizes, and coordinates actions required to achieve the operational objectives of the Process Validation Group
• Plans group resources (human, material resources, etc.)

Process and cleaning validation activities:

• Initiates and actively leads meetings for process validation strategy development, risk evaluation
• Coordinates different activities during process validation
• Suggests manufacturing process improvement to better meet ISO standard requirements
• Ensures an effective manufacturing teams support during process validation
• Actively indicates risks and translates them to the validation team
• Participates and manages projects related to process and cleaning validation
• Actively uses PPI tools and methods:
• Participates and manages JDI and Kaizens
• Goes to GEMBA walks and implements 5 S
• Makes proposals related to the improvement of the functions performed and the activities of the unit

REQUIREMENTS:

• Degree in molecular biology, chemistry, biochemistry, genomics, or similar fields.
• Work experience in the field of quality or validation
• Knowledge of the requirements of quality management system standards, EN ISO 13485, Medical devices, ISO 90001
• Knowledge and skills of the principles of the Good Manufacturing Practice (GMP) system
• Knowledge of product properties
• Effective communication skills in formal and informal discussions with colleagues and management
• Skills to coordinate group activities and resources between different projects
• Knowledge of biotechnology processes, analytical methods used in biotechnology.
• Knowledge of general principles of documentation
• Excellent English language skills
• Computer literacy

THE COMPANY OFFERS:

• Meaningful, mission-based work.
• The innovative environment of the rapidly growing international company.
• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential.
• An exciting opportunity to be part of a dynamic global organization and work with experienced professionals.
• Professional career opportunities.
• Work in an ambitious team.
• Monthly salary 3200 - 4300 Eur (Brutto) and additional benefits package.