Position: Technical Writer - (DLM - Digital Line Management Focus)
Location: 100% Remote
Job Overview We are looking for a skilled Technical Writer to create precise, high-quality, and GxP-compliant documentation specifically for Digital Line Management (DLM) processes within SAP S/4HANA implementations in the pharmaceutical industry. You will focus exclusively on documenting digital workflows for production line operations including line setup, changeovers, real-time monitoring, performance tracking, digital batch records, equipment status management, and integration between DLM, MES, and SAP manufacturing modules. You will work closely with DLM/MES experts, SAP functional consultants, production teams, and quality/regulatory stakeholders to produce clear, user-centric documentation that supports operators, supervisors, and validation efforts.
Key Responsibilities
- Develop and maintain comprehensive technical documentation for Digital Line Management (DLM) in SAP S/4HANA, including:
- User guides and step-by-step work instructions for line operators
- Process narratives and flow diagrams for DLM workflows
- Functional specifications and configuration guides
- Training materials, quick-reference job aids, and release notes
- Document DLM-specific processes such as digital line preparation, dynamic scheduling, real-time line performance dashboards, electronic signatures, exception handling, and seamless integration with MES systems and SAP PP/PI modules.
- Ensure all documentation adheres to pharmaceutical regulatory requirements (GMP, FDA 21 CFR Part 11, Annex 11, GxP) and supports computer system validation (CSV) activities.
- Collaborate directly with DLM subject matter experts and SAP teams to accurately capture current and future-state processes.
- Review, update, and version-control DLM documentation to reflect system enhancements, configuration changes, and implementation lessons learned.
Required Qualifications
Proven experience as a Technical Writer supporting digital manufacturing, MES, or ERP systems in regulated (preferably pharmaceutical) environments.
Strong knowledge of SAP S/4HANA, particularly in manufacturing execution areas (PP/PI, Digital Manufacturing, or related modules).
Hands-on understanding of Digital Line Management (DLM) concepts and workflows in pharmaceutical production environments.
Ability to write clear, structured, and concise documentation that translates complex digital line processes for end-users (operators, line leads), IT teams, and quality/validation personnel.
Proficiency with documentation tools (e.g., MadCap Flare, Adobe FrameMaker, Confluence, Visio, structured authoring/XML-based tools).
Familiarity with GxP-regulated documentation standards and validation expectations in life sciences.
Strong self-management skills and comfort working fully remote in a fast-paced, deadline-driven setting.
Preferred Qualifications
- Prior experience documenting Digital Line Management (DLM) or similar digital manufacturing solutions in pharma SAP S/4HANA projects.
- Exposure to SAP Digital Manufacturing Cloud, common MES platforms (e.g., Werum PAS-X, Rockwell PharmaSuite), or DLM-specific configurations.
- Background in pharma production line operations or digital transformation initiatives.
This 100% remote position is ideal for a technical writer with specialized expertise in Digital Line Management (DLM) within pharmaceutical manufacturing and SAP S/4HANA. If you have deep knowledge of DLM processes
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