Digital CMC Process Engineer & Technical Writer

Insight Global; Rahway (NJ); On-site; USD 95,000 - 130,000; Full time

Job summary

Insight Global is seeking a detail-oriented Process Engineer with a focus in technical writing to support a pharmaceutical company’s Digital CMC initiative. This role blends process engineering expertise with precise documentation to ensure accuracy, compliance, and usability of critical procedures and templates.

The ideal candidate will have 5+ years in process engineering within life sciences or pharma, strong experience with GMP/GxP and digital systems, and familiarity with Power BI and Excel

Qualifications

• 5+ years of process engineering experience in pharma/biotech, manufacturing environment.
• Expert in authoring SOPs, testing protocols, and digital testing.
• Experience with DeltaV, SAP and MES systems and integration.
• Strong knowledge of tech transfer and data management in pharma.
• Proficiency with Power BI and advanced Excel (pivot tables, VBA, macros, IF formulas).
• Experience in a large molecule drug substance environment.
• Bachelor's degree in Chemical Engineering or related field.

Responsibilities

• Technical Authoring & Documentation: Create technical protocols, reports, and governing procedures from scratch; ensure clarity, accuracy, and GMP/GxP compliance.
• 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.

Skills

Process engineering

Technical writing

Regulatory compliance

Data management

GMP/GxP awareness

Communication

Education

Bachelor's degree in Chemical Engineering

Tools

DeltaV

SAP

MES

Power BI

Excel

Job description

Insight Global is seeking a detail-oriented Process Engineer with a focus in technical writing to support a pharmaceutical company’s Digital CMC initiative. This role blends process engineering expertise with precise documentation to ensure accuracy, compliance, and usability of critical procedures and templates.

The ideal candidate will have 5+ years in process engineering within life sciences or pharma, strong experience with GMP/GxP and digital systems, and familiarity with Power BI and Excel