Process Engineer

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.

The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

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. xhyhwjd
• PKM Enablement: Translate process knowledge into structured, reusable documentation and data formats that can be integrated into PKM and other digital CMC platforms.