Process Engineer
insight globalRahway (NJ)
About the role
Required Skills & Experience:
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 “IF” formulas)Experience working within a large molecule drug substance environment Bachelor's degree in Chemical Engineering or a related field.
Nice to Have
Skills & Experience: Continuous Manufacturing experience Proven experience in a digitization project
Job Description:
We are seeking a detail-oriented Process Engineer with a focus in technical writing to support a pharmaceutical company’s 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:
Technical Authoring & Documentation: Create technical protocols, reports, and governing procedures from scratch; ensure clarity, accuracy, and compliance with GMP/GxP and regulatory standards. Template Execution: Develop, adapt, and maintain standardized process recipe templates and harmonize terminology for small and large molecule drugs Data & Digital Tools: Use Power BI, advanced Excel (pivot tables, VBA, macros, creative “IF” formulas), and data visualization tools to validate calculations, generate insights, and structure process knowledge Validation of Calculations: Verify the accuracy and integrity of technical calculations within protocols and reports, ensuring precision and regulatory compliance. Updating Governing Procedures: Revise, maintain, and standardize official governing procedural documentation to ensure alignment with regulatory and internal compliance standards. PKM Enablement: Translate process knowledge into structured, reusable documentation and data formats that can be integrated into PKM and other digital CMC platforms.
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