Contract Process Engineer (PHARMA PLANT, WEST) #HJW

Contract Process Engineer (PHARMA PLANT, WEST) #HJW

• Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.
• Develop, maintain, review and troubleshoot the process control system recipe/models. Guide process engineers in the 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 a cross-functional team for product transfer of new products 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 a team for product/process transfer between the different process-centric teams 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 to 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 of 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 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.

REQUIREMENTS

• Bachelor's Degree, preferably in Chemical Engineering or a degree in science with a major in Chemistry
• At least 5 years' experience in pharmaceutical (API), with relevant manufacturing environment for senior position