Facilities Engineer Technical Deviation Writer

Alphanumeric is looking for a Facilities Engineer Technical/Deviation Writer in Cambridge, MA who is familiar with GxP investigation activities, including deviation reports, as well as writing procedures and acting as a document coordinator.

Contract position with an hourly pay of $59.00

We are working with one of our oldest clients, a company that was built on the idea of advancing medical and pharmaceutical technologies to improve lives. This individual will be responsible for updating, authoring, and reviewing FEV (Facilities, Engineering, and Validation) standard operating procedures and other controlled documents.

Other duties include collaborating with stakeholders from multiple departments, managing GMP documents, completing change controls, and participating in corrective and preventative actions, among other things.

Education and Experience:

1. Requires a bachelor's degree, preferably in a scientific/engineering discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
2. Demonstrates a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
3. A minimum of 3 years technical experience in a regulated GxP environment.
4. Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving for equipment related issues.
5. Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurate.
6. Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
7. Working knowledge of SAP or similar deviation management system, and Veeva or similar quality document system.

Must be able to work W2