Facilities/Engineering Change Control Technical Writer (cGMP – Pharmaceutical)   JD820724

Norwood, MA area

Summary:

DPS Engineering is looking for capable Technical Writers to work with a pharmaceutical client in the Norwood/Canton, MA area. This individual will be expected to raise and author facilities change controls, work orders, SOPs, user requirements, and turnover packages.

Core Responsibilities:

·         Responsible for writing and editing engineering documents including but not limited to change controls, work orders, turnover packages, and user requirements

·         Create new cGMP documents with assistance from within the department.

·         Manage document comments in order to answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements.

·         Must be able to extract and coordinate information from multiple sources and consolidate material into technical documentation.

·         Maintain files and logs in a GMP state.

Education and Qualifications:

·         Bachelor’s degree in Engineering or Sciences is preferred.

·         2-4 years of experience working within a GMP environment.

·         Demonstrated document editing and proofreading experience.

·         Must have knowledge around CMMS program i.e. Pilgrim, Maximo, etc.

·         Must understand how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document.

·         Strong written and oral communication skills

·         Highly organiz58112.4558084ed with effective time management (ensuring completion of work tasks).

·         Strong attention to detail.

·         Ability to work well cross-functionally with various people and groups.