Job Description
GMP Technical Writer

Contract: 6+ months with strong potential for contract-to-hire
Location: Greater Madison Area, WI - Onsite

Automated Systems, Inc. (ASI) is seeking an experienced GMP Technical Writer to support documentation and quality system activities at a pharmaceutical manufacturing site in the Greater Madison Area. This role will support backlog closure across Deviations, CAPAs, Change Controls, SOPs, and engineering documentation, working closely with Automation, Utilities, and Facilities engineering teams.

The ideal candidate will combine strong technical writing skills with pharmaceutical GMP experience and a solid understanding of quality systems and document control. This position requires the ability to gather complex technical information from engineers and translate it into clear, accurate, compliant, and audit-ready documentation.

Key Responsibilities

• Author, revise, and finalize GMP documentation,including Deviation reports, CAPAs, Change Controls, engineering workorders, SOPs, and Work Instructions.
• Partner with Automation, Utilities, and Facilitiesengineers to gather technical information and translate engineeringconcepts into clear, GMP-compliant documentation.
• Support Deviation investigations, root causedocumentation, corrective and preventive actions, and Change Controlpackages, including classification and rationale.
• Manage document workflows through VeevaQualityDocs, MasterControl, or comparable electronic quality managementsystems, including review, approval, and effective-date processes.
• Author and edit SOPs, Work Instructions,engineering procedures, and related controlled documents in accordancewith site and global quality requirements.
• Maintain documentation trackers using Smartsheet,Excel, or similar tools to monitor open items, approval queues,dependencies, and closure timelines.
• Coordinate document interdependencies acrossengineering and quality functions to prevent routing delays and supporttimely closure of documentation backlogs.
• Ensure documentation meets cGMP, data integrity,document control, version control, and audit-readiness requirements.
• Apply strong attention to detail and criticalthinking when reviewing technical content for accuracy, completeness,consistency, and compliance.

Requirements

Required Qualifications & Experience

• 4+ years of GMP technical writing experiencewithin pharmaceutical, biotechnology, medical device, or other regulatedmanufacturing environments.
• Demonstrated experience authoring Deviations,CAPAs, Change Controls, SOPs, Work Instructions, and other GMP-controlleddocumentation.
• Experience supporting Deviation investigations andCAPA processes, including documenting root causes, corrective actions, andpreventive actions.
• Strong understanding of cGMP documentationpractices, data integrity, document control, version control, andreview/approval workflows.
• Experience with electronic quality management ordocument management systems such as Veeva QualityDocs, MasterControl,TrackWise, or equivalent platforms.
• Experience using Smartsheet, Microsoft Excel, andMicrosoft Office for documentation tracking and project coordination.
• Relevant experience supporting engineeringorganizations, particularly Automation, Utilities, Facilities,Manufacturing, or related technical functions.
• Strong technical writing and editing skills, withthe ability to translate complex technical information into clear,concise, compliant, and audit-ready documentation.
• Excellent attention to detail, organization,critical thinking, and problem-solving skills.
• Ability to work effectively with engineers,Quality, Operations, and other cross-functional stakeholders in afast-paced pharmaceutical manufacturing environment.
• Bachelor's degree in a relevant discipline such asTechnical Writing, Engineering, Science, Business, Computer Science, or arelated field, or equivalent combination of education and experience.

Preferred Qualifications

• 2+ years of pharmaceutical industry experiencein a GMP-regulated environment.
• Experience authoring or maintaining electronicbatch record recipes.
• Familiarity with systems such as ComplianceWire,JD Edwards, Unicorn, or similar pharmaceutical quality/manufacturingplatforms.
• Working knowledge of manufacturing and laboratoryoperations and the ability to quickly learn new processes, systems, andtechnologies.
• Experience supporting quality system backlogreduction, documentation remediation, or continuous improvementinitiatives.