POSITION SUMMARY

Incumbent will be responsible for leading product manufacturing campaigns from the start of production, and providing technical supervision with respect to quality and EHS until completion and release of the material.

POSITION RESPONSIBILITIES

• Develop Manufacturing/Operating Instructions and necessary Standard Operating Procedures.
• Develop, maintain and troubleshoot the process control system recipe/Models.
• Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review.
• Develop, implement and monitor robust preventive measures for processing issues.
• Play a pro-active role in ensuring the site safety and quality standards are adhered to.
• Proactively monitor, identify, develop and implement improvements in processes and equipment.
• Communicate on a regular basis to the plant personnel on process updates.
• Train the process technicians on the process and procedures as required.
• Ensure we adhere to our approved procedures and update these as required.
• Author CPV plan and reports.
• Own one or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
• Subject matter expert for selected system/topics.
• Provide guidance to junior process engineers.
• Other tasks as assigned by manager.

• Degree in Engineering, preferably in Chemical Engineering
• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding
• Working knowledge of Food and Drug Administration Regulations, and Good Manufacturing Practices
• Proactive, has experience with high performance teams, strong interpersonal and project management skills
• Strong written and verbal communication skills
• Microsoft Applications skills, DeltaV
• Preferably, at least 6 years of experience in a relevant manufacturing environment.