Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Process Engineer

Job Summary

The Process Engineer is responsible for designing, implementing, and optimizing manufacturing processes to ensure efficiency, compliance, and quality in pharmaceutical production. This role requires expertise in process design, equipment optimization, troubleshooting, and adherence to regulatory standards such as FDA, EU GMP, and ICH guidelines.

Key Responsibilities

• Process Design and Optimization:

• Design and optimize manufacturing processes for pharmaceutical products, ensuring scalability and efficiency.

• Identify areas for process improvement to increase yield, reduce waste, and improve product quality.

• Equipment Qualification and Validation:

• Oversee the selection, installation, and qualification of manufacturing equipment.

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment and processes.

• Troubleshooting and Support:

• Analyze and resolve technical issues related to manufacturing processes and equipment.

• Provide technical support to production teams to ensure smooth operations.

• Regulatory Compliance:

• Ensure all processes comply with regulatory requirements (FDA, EU GMP, etc.).

• Maintain accurate and detailed documentation for audits and inspections.

• Project Management:

• Lead or support process improvement projects, including budgeting, timelines, and resource allocation.

• Collaborate with cross-functional teams, including Quality, R&D, and Manufacturing.

• Process Monitoring:

• Develop and implement monitoring systems to track process performance and ensure consistency.

• Analyze data to identify trends and make data-driven decisions.

• Training and Development:

• Train staff on new processes, equipment, and technologies.

• Stay current on industry trends and innovations to apply best practices.

Qualifications

• Education:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field (Master’s preferred).

• Experience:

• 3–5 years of experience in pharmaceutical manufacturing or a related industry.

• Hands-on experience with process design, validation, and troubleshooting.

• Skills and Competencies:

• Strong understanding of pharmaceutical manufacturing processes (e.g., granulation, blending, tablet compression, coating, sterilization).

• Knowledge of regulatory standards (FDA, ICH, EU GMP) and Good Manufacturing Practices (GMP).

• Proficiency in process simulation software and data analysis tools.

• Excellent problem-solving, project management, and communication skills.

Work Environment

• Primarily works in manufacturing facilities and cleanroom environments.

• May require standing, walking, or working around manufacturing equipment for extended periods.

• Occasional travel may be required for project implementation or training.

Additional Information

• Reports findings, progress, and recommendations to management.

• Actively participates in audits and inspections.