Engineer II, Manufacturing Engineering
Engineer II, Manufacturing Engineering
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)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 OfficeJob Description
How will you make an impact
The ThermoFisher Scientific St. Louis site is a multiproduct and multiclient biopharmaceutical site with manufacturing facilities for pharmaceutical products for both (pre)clinical trials and commercial applications.
The Engineer II fulfills several key functions within the team; Management of quality records and compliance tasks management and tracking of work orders and workflow for the sites fit and finish program GMP documentation support for capital projects and SAP/CMMS support for the department. The Engineer II role is part of the Engineering team and reports to the Manager of Manufacturing Engineering.
What will you do
- Track all quality records for the engineering department to ensure ontime completion for all records.
- Support initiation of new quality records as required for engineering / capital projects.
- Drive closure of intermediate tasks on quality records to ensure departmental compliance/ontime completion.
- Track metrics and workflow of fit and finish program.
- Support routine fit and finish inspections of the facility.
- Support coordination of external contractors to complete work in the production suites.
- Serve as departmental SME on CMMS usage for creating tracking and closing work orders for work performed within the engineering department.
- Serve as a primary point of contact during audits (internal external regulatory) and work with the compliance team to provide timely accurate information to support audit requests related to facilities and engineering.
- Support the authoring of GMP documents as the need arises to support engineering department objectives.
- Support start up and commissioning activities on capital projects as the need arises.
How will you get here
- Bachelors Degree or higher education in Engineering (Chemical Mechanical Electrical Bio) or equivalent experience in the pharmaceutical industry and related degree.
- Associates Degree and 2 years of related professional experience.
- GED and 5 years of related experience.
- 2 years of industry experience or experience in a similar industry
- Past experience managing work orders in SAP or equivalent CMMS software
Knowledge Skills Abilities
- Excellent written and verbal communication
- Strong attention to detail
- Proficient with Microsoft Office tools.
- Experience using CMMS software to manage work.
- Experience authoring documents in a GMP setting.
- Experience working in a cleanroom.
- Prior experience working on commissioning and validation in a pharmaceutical setting.
At Thermo Fisher Scientific each one of our 65000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
Employment Type
Full-Time
