Job Title: Validation Engineer III
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
The Bedford site manufactures consumables (Tropix Chemiluminesence, POP Genetics Analysis Polymers and POROS Chromatography Resin) for life sciences customers.
How will you make an impact?
The Validation Engineer III will function as a key member of the Manufacturing Science & Engineering team. We are seeking an energetic individual with strong communication, leadership, technical and operational skills to join our dynamic and fast paced team. The Validation Engineer will be responsible for validation and qualification activities associated with capital projects involving the installation and/or renovation of process equipment, utilities and processes.
What will you do?
- Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
- Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications
- Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
- Develops, maintains, or reviews validation and compliance documentation including, protocols, and engineering change notices
- Support validation activities for plant expansions, scale ups and process improvement projects
- Ability to manage multiple projects/priorities in a dynamic environment
- Maintain and support a safety and quality culture.
How will you get here?
- Bachelor's or higher in Engineering or technical discipline
- A minimum 5+ years' of validation experience
Knowledge, Skills, Abilities
- Ability to work with numerous departments and levels of employees.
- Knowledge of current Good Manufacturing Practices (cGMP)
- Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, Deviation Investigation and Change Control process.
- Understanding or process/equipment validation
- Understanding of statistical tools and statistical process control
- Project management skills are a plus
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