Process and Cleaning Validation Lead, MSAT

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Process and Cleaning Validation Lead in MSAT, where you'll contribute to global health through innovative process development and optimization. You'll provide leadership in process validation and cleaning validation and manufacturing support across our facility and suites. Working at the intersection of process, validation and manufacturing, you'll collaborate with cross-functional teams to ensure successful execution of manufacturing processes while driving continuous improvement initiatives. Your expertise will be vital in resolving complex technical challenges, conducting investigations, and implementing solutions that maintain our high standards of quality and efficiency.

REQUIREMENTS:
• Advanced Degree plus 5 years of experience, or Bachelor's Degree plus 7 years of experience in GMP-regulated pharmaceutical/biotech manufacturing
• Preferred Fields of Study: Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or related scientific field
• Strong technical expertise in process and cleaning validation for drug substance
• Expert knowledge of cGMP regulations and quality systems is a must
• Proficiency in project management
• Strong analytical and statistical analysis capabilities
• Excellent verbal and written communication skills
• Ability to work collaboratively in a matrix environment
• Proficiency with Microsoft Office suite
• Experience mentoring colleagues and providing technical training
• Strong problem-solving skills and attention to detail
• Ability to support manufacturing operations as needed, including some weekend/off-hours coverage