Senior Process Engineer

The Senior Process Engineer independently leads process characterization, optimization strategies, and troubleshooting activities within operations, manufacturing, pilot plant, or capital project environments. This role applies advanced and diverse engineering principles to design, implement, and improve major systems, processes, or capital projects, while analyzing and interpreting complex data to drive operational excellence.

Key Responsibilities

• Complete complex or novel engineering assignments requiring the development of new or improved techniques and procedures.
• Develop and implement engineering policies and procedures impacting multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on both ongoing and project-specific bases.
• Employ and adapt advanced engineering techniques within and beyond areas of expertise.
• Serve as a recognized subject matter expert in one or more technical areas, determining methodologies and standards for engineering solutions.
• Plan and conduct large-scale projects using mature engineering knowledge and sound judgment.
• Develop innovative technical solutions for complex problems, using creativity and cross-functional collaboration.
• Partner with research, manufacturing, process development, utilities, facilities, QA, and validation teams to define system/facility modification requirements.
• Collaborate with project managers to deliver design and engineering projects within established schedules, budgets, and quality standards.
• Coordinate the work of consultants, architects, and engineering firms in developing standard design documentation.
• Develop and manage departmental and project budgets encompassing multiple engineering disciplines.
• Implement new product introductions and major projects within Drug Substance (DS) operations, including procedures, automation, batch records, and validation activities.
• Analyze operational data to identify root causes of deviations and inefficiencies; develop and implement data-driven process improvements.
• Support timely investigations, root cause analyses, and CAPA implementation to ensure compliance and prevent recurrence.
• Assist in developing and executing process validation protocols and reports, analyzing validation data for compliance and performance robustness.
• Establish and monitor process parameters, control limits, and performance metrics to ensure operational excellence.
• Lead or support change control initiatives in alignment with regulatory and operational requirements.
• Configure process monitoring requirements in MBRs/GMBRs and data systems (e.g., Enterprise Data Lake, Spotfire) in compliance with GMP and company guidelines.
• Utilize Application Life Cycle Management (ALM) systems during validation and navigate SAP for master data, process orders, BOMs, and inventory management.
• Troubleshoot SAP-MES PAS/X connectivity and IDoc communication issues, ensuring accurate process integration and data flow.
• Assess and prioritize process or equipment modifications; support project execution and manage technical deliverables.
• Provide leadership in managing contractors, vendors, and cross-functional teams to achieve project goals.
• Apply financial analysis tools for project cost estimation and control.

Education:

• Doctorate in Engineering, OR
• Master’s in Engineering + 2 years of relevant experience, OR
• Bachelor’s in Engineering + 4 years of relevant experience

Preferred Qualifications:

• Experience in biotechnology or pharmaceutical manufacturing, particularly downstream processes.
• Proven experience managing SOPs, eBRs, and change controls within a regulated GMP environment.
• Expertise in process validation, deviation management, and CAPA implementation.
• Proficiency with SAP, MES PAS/X, Spotfire, and data monitoring tools.
• Demonstrated success implementing new product introductions or large-scale capital projects in Drug Substance operations.

• 8-months contract with possible extension
• Administrative Shift