Description
Job Description
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that our solutions are both timely and effective. Your contributions will be essential in ensuring that our manufacturing processes are efficient, reliable, and of the highest quality, ultimately helping us deliver life-saving medicines to those who need them most.
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizers mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
The Associate Process Engineer supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule for mAb products. The Associate Process Engineer will work on interdisciplinary and cross functional teams, to own and implement process improvements, and lead/participate in process troubleshooting.
Requirements
How You Will Achieve It
Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
Delivers Right first-time execution and continuous improvement; Monitor, Identify and/or Communicate process and compliance trends in real time.
Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current on assigned training.
Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
Generates work requests when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders.
Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
