GMP Technical Writer

Automated Systems, Inc. (ASI); Wisconsin; On-site; USD 85,000 - 120,000; Full time

Job summary

Automated Systems, Inc. (ASI) is seeking a GMP Technical Writer with engineering documentation experience to support backlog closure across Deviations, CAPAs, and Change Controls at a pharmaceutical manufacturing site in Kenosha County, WI.

You will collaborate with Automation, Utilities, and Facilities engineers to produce GMP-compliant documents and manage document routing in QMS tools. Embedded with the Engineering team, this role emphasizes structured writing, document control, and quality

Qualifications

• 4+ years of GMP technical writing experience in pharmaceutical, biotech, or medical device manufacturing.
• Demonstrated experience authoring Deviation reports, CAPA records, and Change Control packages.
• Proficiency with electronic quality management systems (Veeva QualityDocs, MasterControl, or TrackWise).
• Strong understanding of GMP documentation principles (data integrity, version control, review/approval workflows).
• Excellent written communication and ability to distill complex engineering information into compliant, auditable documents.

Responsibilities

• Author and finalize GMP documents including Deviation reports, CAPA records, Change Control packages.
• Interface with Automation, Utilities, and Facilities engineers to gather technical content and translate to GMP-compliant documentation.
• Manage document routing in Veeva QualityDocs and/or MasterControl through review, approval, and effective date cycles.
• Draft and revise SOPs, Work Instructions, and engineering procedures to meet LQS/GQS requirements.
• Maintain documentation trackers (Smartsheet, Excel) for open items, approval queues, and closure timelines.
• Support change control classification and rationale documentation under applicable site SOPs.
• Coordinate cross-discipline document interdependencies to prevent routing bottlenecks.

Skills

GMP technical writing

Engineering documentation

Document control

Auditable documentation

Tools

Veeva QualityDocs

MasterControl

TrackWise

Smartsheet

Excel

Job description

Automated Systems, Inc. is seeking a GMP Technical Writer with engineering documentation experience to support backlog closure across Deviations (DEVs), CAPAs, and Change Controls at one of our clients pharmaceutical manufacturing sites located in the Kenosha County Area, WI.

This is a cross-discipline support role embedded with the Engineering team, providing structured writing, document control, and quality system support to Automation, Utilities, and Facilities engineers who need bandwidth relief to focus on active project execution.

Key Responsibilities

• Author and finalize GMP documents including Deviation reports, CAPA records, Change Control packages, and engineering work orders.
• Interface with Automation, Utilities, and Facilities engineers to gather technical content and translate to GMP-compliant documentation.
• Manage document routing in Veeva QualityDocs and/or MasterControl through review, approval, and effective date cycles.
• Draft and revise SOPs, Work Instructions, and engineering procedures to meet LQS/GQS requirements.
• Maintain documentation trackers (Smartsheet, Excel) for open items, approval queues, and closure timelines.
• Support change control classification and rationale documentation under applicable site SOPs.
• Coordinate cross-discipline document interdependencies to prevent routing bottlenecks.

Requirements

• 4+ years of GMP technical writing experience in pharmaceutical, biotech, or medical device manufacturing.
• Demonstrated experience authoring Deviation reports, CAPA records, and Change Control packages.
• Proficiency with electronic quality management systems — Veeva QualityDocs, MasterControl, or TrackWise.
• Strong understanding of GMP documentation principles (data integrity, version control, review/approval workflows).
• Excellent written communication and ability to distill complex engineering information into compliant, auditable documents.

Preferred Qualifications

• Experience supporting engineering-side documentation (automation, utilities, or facilities).
• Familiarity with quality systems or equivalent top-tier pharma QMS frameworks.
• Exposure to legacy site remediation or quality system transition projects.
• Proficiency in Smartsheet or equivalent project tracking platforms.