"Alerted.org

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, 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.

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.)

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.