Technical Writer

Job Responsibilities Own end-to-end engineering document workflows within an Electronic Document Management System (EDMS), from redline updates through review, approval, and final submission. Coordinate with engineers, project managers, document control, Quality, and other stakeholders to gather inputs and resolve documentation issues.

Title : Technical Writer

Location: New York

Duration : 6 Months

Employment Type: Contract

Job Responsibilities

• Own end-to-end engineering document workflows within an Electronic Document Management System (EDMS), from redline updates through review, approval, and final submission.

• Manage and track multiple document workflows, ensuring timely completion of review and approval cycles.

• Coordinate with engineers, project managers, document control, Quality, and other stakeholders to gather inputs and resolve documentation issues.

• Update engineering documents based on redlines and revisions, ensuring accuracy and consistency.

• Maintain document version control, ensuring outdated versions are archived and current versions are properly identified.

• Review document changes for compliance with Good Documentation Practices (GDP), GMP, and internal standards.

• Coordinate document routing, review, approval, and submission within the appropriate document management systems.

• Verify document content, metadata, attributes, and audit trails before final submission.

• Monitor workflow status, resolve bottlenecks, and escalate delays when necessary.

• Support documentation training, workflow procedures, and continuous improvement initiatives.

• Prepare monthly workflow completion reports and provide regular project updates.

Required Qualifications

• Experience managing engineering document workflows in a GMP-regulated environment.

• Hands-on experience with EDMS platforms and document routing processes.

• Experience with document redlining, revision control, version management, and workflow tracking.

• Knowledge of GMP, GDP, documentation standards, and audit trail requirements.

• Experience coordinating document reviews, approvals, and submissions across engineering, Quality, and project teams.

• Strong attention to detail, communication, coordination, and organizational skills.

Preferred Qualifications

• Experience routing documents in Veeva and ValGenesis.

• Experience with ASR automated system reviews, including Lab, Facility, and Automations.

• Experience preparing engineering documentation, workflow procedures, training materials, and completion reports.

• Familiarity with regulated pharmaceutical, biotechnology, or other GMP environments.

Pay Scale

Anticipated hourly pay range: $30/hr to $45/hr on W2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.