Process Engineering Technical Writer - Cambrex

The PE Technical Writer will be responsible for consistently generating high quality technical documents, such as batch records, deviations, protocols, and reports based on data collected by other members of the Process Engineering team that meet the needs of other departments, clients, and regulators.  Compliance with SOPs, cGMP, and other regulatory guidelines is required to perform most job tasks.

• Drafting and revising controlled documents such as batch records, cleaning records, process validation protocols and reports, WINS and SOPs, campaign reports, investigation/deviation reports and other documents needed to support Operations while following established guidelines for correctness, completeness, clarity, and format.
• Coordinate the approvals of these documents through the use of software such as MasterControl and TrackWise.
• Compile and present data from multiple sources such as executed batch records and executed analytical records.
• Maintain open communication with members of Process Engineering, Operations, and QA to ensure timely delivery of high quality documents to support evolving business needs.
• Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.

• Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers.
• Fluent in written English.
• Familiarity with compliance requirements within cGMP with an emphasis on procedures, process validations, and reporting requirements preferred.
• Demonstrated excellence in advanced word processing using Microsoft Word and other Microsoft Office products.
• Demonstrated computer literacy, including spreadsheets, structural drawings, databases, and communication packages preferably in a Windows environment.
• Ability to work in a highly independent and self-directed work environment.

• Associate degree in a technical discipline or closely related field is required.
• Minimum of 2 or more years of experience in a cGMP regulated manufacturing environment highly preferred.