Engineering Technical Writer - cGMP Documentation Lead

Deciem Inc; Canada; Hybrid; CAD 55,000 - 60,000; Full time

Benefits offered by this job

Vacation & Personal Days

Paid parental leave

Catered lunches

Employee Assistance Program

Job summary

Deciem Inc is seeking a Technical Writer, Engineering to develop, coordinate, and maintain technical documentation for capital projects, equipment qualification, validation, and technology transfer. The role ensures accuracy, compliance, and audit readiness in line with cGMP and regulatory standards.

Based at our Production Facility in Etobicoke, this full-time on-site role collaborates with Engineering, Quality, Manufacturing, and R&D to drive documentation standards and continuous improvements.

Qualifications

• College Diploma, bachelor’s degree or equivalent education in a technical, scientific, or related discipline.
• 1 - 3 years of technical writing experience in a regulated manufacturing environment.
• Experience preparing manufacturing documentation in compliance with cGMP, Health Canada, FDA, ISO.
• Strong technical writing, editing, and document management skills.
• Excellent organizational and project coordination skills.

Responsibilities

• Develop, review, and maintain technical documentation supporting Engineering, Validation, and Technology Transfer activities.
• Ensure documentation is accurate, complete, and compliant with DECIEM procedures, cGMP and regulatory standards.
• Coordinate document deliverables across project lifecycle with Reviews and Approvals.
• Track documentation status and communicate risks affecting timelines or compliance.
• Support revisions from engineering changes, deviations, CAPAs, and change controls.
• Partner with multiple departments to support capital projects and new product introductions.
• Support audits by ensuring documentation is complete and inspection ready.
• Provide guidance on documentation standards and templates to promote consistency.
• Maintain documentation trackers to monitor status and on-time deliverables.

Skills

Technical writing

Documentation management

Regulatory compliance

Project coordination

Cross-functional collaboration

Education

Bachelor's degree or equivalent

Job description

Deciem Inc is seeking a Technical Writer, Engineering to develop, coordinate, and maintain technical documentation for capital projects, equipment qualification, validation, and technology transfer. The role ensures accuracy, compliance, and audit readiness in line with cGMP and regulatory standards.

Based at our Production Facility in Etobicoke, this full-time on-site role collaborates with Engineering, Quality, Manufacturing, and R&D to drive documentation standards and continuous improvements.