Engineer III, Validation

at  Thermo Fisher Scientific

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

KNOWLEDGE, SKILLS, ABILITIES

• Good understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820) requirements
• Innovative thinking and problem-solving skills (root cause analysis, CAPA)
• Attention to detail and ability to identify and remediate compliance issues
• Highly effective verbal and written skills
• Self-motivated, proactive, and capable of adhering to strict deadlines
• Ability to work well under pressure and multi-task
• Proven knowledge of Quality Management System tools
• Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
• Excellent interpersonal, organizational, and influencing skills
• Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams
• ASQ certification is desired

WHAT WILL YOU DO?

A Quality Engineer III is responsible for implementing and maintaining the Thermo Fisher processes and procedures used to validate customer systems in a scalable, efficient manner. Additionally, this individual is responsible for leading the validation initiative of large and/or highly customized systems which includes deliverable definition, schedule creation/alignment, protocol development/execution, discrepancy management, and project close-out. This role will also lead CAPA investigations for internal quality issues and customer complaints.
The role demands a solid technical background across a variety of scientific fields and fundamentals on Validation Lifecycle which includes Master Validation Planning (MVP), Change Control Management, Risk Assessments, User Requirement Specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).

RESPONSIBILITIES INCLUDE:

• Development and maintenance of Master Validation Master Plan for site
• Participate in technical aspects of equipment and software validation at the site, including Equipment Qualifications and re-qualifications
• Support the validation function by assisting with validation documentation, executing qualification protocols and compiling data
• Lead CAPA investigations
• Lead multi-functional team members supporting the Customer Complaint Process
• Execute Risk and Impact Assessments
• Interact directly with customers and internal groups
• Drive product and process changes to improve product quality