Process Optimization Specialist
We are seeking an experienced Process Optimization Specialist to join our dynamic team. This role involves leading initiatives to enhance API and excipient production processes, ensuring compliance with regulatory requirements and GMP standards.
Key Responsibilities:
1. Process Enhancement: Identify areas for improvement, recommend changes, and implement solutions to increase efficiency, yield, and cost-effectiveness.
2. Troubleshooting: Provide hands-on support to resolve technical issues during production using a data-driven approach to diagnose and address root causes of process deviations.
3. Regulatory Compliance: Ensure all processes meet regulatory requirements, GMP, and safety standards, supporting the preparation and review of documents for regulatory audits and inspections.
4. Production Performance Monitoring: Utilize advanced process monitoring tools to track production performance, identifying discrepancies or areas of concern, and implementing corrective actions as necessary.
5. Cross-Functional Collaboration: Work closely with other departments, including Engineering, Quality Assurance, and Production teams, to ensure seamless communication and process alignment.
Requirements:
* Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Bioprocessing, or a related field.
* Minimum 5 years of experience in pharmaceutical production, specifically in API or excipient manufacturing.
* Strong understanding of process engineering, process optimization, and troubleshooting in a regulated pharmaceutical environment.
* Knowledge of GMP, safety regulations, and industry standards.
* Familiarity with production systems, automation tools, and data analysis software.
* Excellent problem-solving skills and ability to work independently and collaboratively.
* Strong communication skills, with the ability to work effectively across teams and departments.