Process/Operations Engineer

Under general supervision, the Process/Operations Engineer provides technical support for process optimization, troubleshooting, and minor engineering projects within manufacturing, pilot plant, or capital projects environments. This role applies fundamental engineering principles to design system modifications, execute experiments, and implement improvements to enhance performance and maintain regulatory compliance.

Key Responsibilities

• Serve as a technical expert for equipment and system troubleshooting.
• Support daily operations to meet schedules and resolve technical issues.
• Conduct routine audits on equipment performance and regulatory compliance.
• Collaborate with cross-functional teams including R&D, Manufacturing, Maintenance, QA, Validation, and Facilities to recommend and implement system modifications.
• Assist Project Managers in executing design and construction projects within time and budget constraints.
• Coordinate with consultants, architects, and engineering firms to develop standard design documents.
• Evaluate equipment modification or installation quotes.
• Prepare basic project cost estimates and schedules.
• Investigate and resolve moderate-scope technical issues.
• Perform technical tasks with clear objectives and defined variables.
• Apply standard engineering techniques and procedures with guidance on unusual problems.
• Organize and present data to interpret results and support recommendations.

Education & Experience Requirements

• Master’s degree in Engineering
  OR
• Bachelor’s degree in Engineering and 2 years of Engineering experience

Preferred Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering is a plus
• Experience in pharmaceutical or biotech environments
• Knowledge of downstream operations (e.g., Purification)
• Familiarity with validation processes and protocol writing
• Experience in process troubleshooting and technical report writing
• Strong skills in:
• Problem-solving and applied engineering
• GLP/GMP interpretation and compliance
• Operation of lab and production equipment
• Technical communication and presentations
• Managing change and technical documentation