Engineer II, Validation
Engineer II, Validation
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Cold Room/Freezers -22degreesF/-6degrees C Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Job Description
This position will be responsible for oversight of equipment validation activities and projects for Thermo Fisher Scientific St. Louis manufacturing facilities. Technical duties include implementing validation strategy adhering to domestic and international GMP regulations ownership and oversight of equipment characterization activities incorporating continuous improvements into qualification validation activities and policies and participating in regulatory inspections. The scope of responsibility encompasses the product life cycle for existing commercial small molecule products as well as emerging products. Creates reviews approves tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units.
Education
Bachelor of Science in Engineering field (Chemical or related)
Experience
2 years in validation pharmaceutical industry
Equivalency
Equivalent combinations of education training and relevant work experience may be considered
Knowledge Skills Abilities
- Strong technical writing skills accuracy attention to detail and technical knowledge
- Excellent communication skills and an ability to effectively collaborate with others to achieve team goals and expectations
- Self-starter with an ability to work in a fast-paced environment and to effectively manage time and prioritize work
- Experience with pharmaceutical manufacturing equipment and processes
- Basic understanding of GMPs
- Excellent computer skills (Microsoft Word Excel Project Power Point etc.)
Employment Type
Full-Time
