Process Engineer, Technical Wiriting

Job Description We are seeking a detail-oriented Process Engineer with a focus in technical writing to support a pharmaceutical companyu2019s Digital CMC initiative. This role combines engineering knowledge with strong technical communication skills to ensure critical documentation, templates, and procedural materials are accurate, compliant, and user-friendly. The ideal candidate has a background in process engineering within life sciences or pharmaceuticals and enjoys working at the intersection of science, compliance, and digital systems. Key Responsibilities: u2022u2003Technical Authoring & Documentation: Create technical protocols, reports, and governing procedures from scratch; ensure clarity, accuracy, and compliance with GMP/GxP and regulatory standards. u2022u2003Template Execution: Develop, adapt, and maintain standardized process recipe templates and harmonize terminology for small and large molecule drugs u2022u2003Data & Digital Tools: Use Power BI, advanced Excel (pivot tables, VBA, macros, creative u201cIFu201d formulas), and data visualization tools to validate calculations, generate insights, and structure process knowledge u2022u2003Validation of Calculations: Verify the accuracy and integrity of technical calculations within protocols and reports, ensuring precision and regulatory compliance. u2022u2003Updating Governing Procedures: Revise, maintain, and standardize official governing procedural documentation to ensure alignment with regulatory and internal compliance standards. u2022u2003PKM Enablement: Translate process knowledge into structured, reusable documentation and data formats that can be integrated into PKM and other digital CMC platforms. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements 5+ years of experience in process engineering within the pharmaceutical or biotechnology industry in a manufacturing environment. Expert in authoring novel technical documentation, including SOPs, testing protocols, and digital testing Expertise in Delta V, SAP, and MES systems, with a proven track record of successful system integration and automation. Strong knowledge of tech transfer processes and data management strategies in a pharmaceutical context Strong knowledge of digital and data-centric tools, including Power BI and Excel (pivot tables, VBA, macros, creative u201cIFu201d formulas) Experience working within a large molecule drug substance environment Bachelor's degree in Chemical Engineering or a related field. Continuous Manufacturing experience Proven experience in a digitization project

Created: 2026-02-12