Senior Technical Writer

Job Title: Technical Writer

Duration:6 months

Location: Minnesota

Seeking a Technical Writer to support gap analysis and standardization of facility qualification processes across a medical device network, with a focus on ISO cleanroom qualifications and equipment software lifecycle documentation. This individual will support Project Guardian initiatives, coordinate with document owners and approvers, and manage documentation updates based on review feedback.

Responsibilities

Conduct gap analyses of facility documentation, qualification processes, and network-wide standards.

Support ISO cleanroom qualification activities, including ISO 14644 requirements.

Manage change notices (CNs) in Windchill and update controlled documents based on reviewer comments.

Support equipment software qualification and lifecycle documentation.

Collaborate with cross-functional teams to drive consistent processes across sites.

Requirements

Experience with facility documentation, cleanroom qualification, or equipment software lifecycle qualification.

Basic knowledge of Windchill and document change control processes.

Strong documentation, gap analysis, and cross-functional collaboration skills.