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
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 adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA).
Focus on Safety and GMP Compliance as operational priorities and as performance measures.
Accountable for the Good Data Management and Data integrity understanding and performance.
Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
Own one or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
Senior position is expected to perform coaching role to junior engineers and manage more complex manufacturing and operation issues. Lead working teams managing projects to support manufacturing process
Degree in Engineering, preferably in Chemical Engineering or Degree in Science with major in Chemistry
