Process Engineer (PHARMA MNC, WEST) #HJW

Process Engineer (PHARMA MNC, WEST) #HJW

• Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.

• Develop, maintain, review and troubleshoot the process control system recipe / models. Guide process engineer in team for the process control system recipe / models development.

• Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review. Participate or lead quality / safety investigations and implement any corrective and preventive actions from these investigations.

• Develop, implement and monitor robust preventive measures for processing issues.

• Lead/ part of cross functional team for product transfer of new product on site and interface with above site and transferring sites to ensure flawless transfer of product to site.

• Able to carry out technical and/or GMP assessment for evaluation of processes.

• Lead/ part of team for product/ process transfer between the different process centric team for the commercial manufacturing and provide technical guidance to the process centric team and/ or operation team during the manufacturing.

• Play a pro-active role and lead changes in ensure 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 and stakeholders on process updates.

• Provide operating instruction and process training to different audiences such as operations, process team, quality operations and engineering.

• Own one or more multiple equipment / GMP systems in production and present the system overview with evidence compliance to internal and external auditors.

• Train the process technicians on the process and procedures as required.

• Ensure adherence to approved procedures and update 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.

• Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, QO, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations.