Senior Process Validation Specialist

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Your role as a Senior Process Validation Specialist is responsible for leading process validation activities in Vilnius Operations. Together with manufacturing and quality assurance teams this specialist will create process validation plans, forms and reports, will coordinate activities during validations and is responsible for process optimization.

Key Responsibilities:

• Leading process validation activities:
  • Ensures all necessary quality standards are met and processes are validated.
  • Initiates and actively leads meetings for process validation strategy development.
  • Coordinates different activities during process validation.
  • Timely fulfils planned activities and provides plans, forms and rapports.
  • 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.
• Validation documentation management:
  • Prepares and updates procedures associated with validation activities in Vilnius site
  • Creates, updates, and approves validation plans, forms, and rapports
  • Generates ideas how to standardize and improve documents creation process
• Non-conformities and deviations management during process validation
  • Analyzes batch records, testing and development data to identify variations
  • Generates ideas how to find the root cause
• Actively uses PPI (Lean) tools and methods:
  • Participates and manages JDI and Kaizens
  • Goes to GEMBA walks and implements 5 S
• Is an active team member:
  • Generates ideas and executes process improval
  • Mentors and coaches the team members
  • Provide technical expertise and knowledge on validation to manufacturing group and beyond.
  • Assists Team Members in resolving issues
  • Willingly shares technical knowledge with others

Requirements:

• BS, Masters or PhD in molecular biology, chemistry, biochemistry, genomics, or similar fields.
• Knowledge of biotechnology processes
• Knowledge of analytical methods used in biotechnology.
• Knowledge of general principles of documentation
• Experience in validation activities.
• Experience with statistic-based sampling plan development, test method development, and writing validation documents for regulated products is preferable
• Excellent English language skills
• Computer literacy (MS Office 365)
• Diligence, attention to detail, responsibility, organization, duty.

Company Offers:

• The innovative environment of the rapidly growing international company.
• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential.
• Salary 1800-2600 Eur Brutto and additional motivation package.