Bioprocess Technician IV - Night Shift 6pm-6am, mAbs

Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need

What You Will Achieve

In this role, you will:

• Executes 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.
• Follow SOPs and batch records for unit operations
• Supports operation of manufacturing equipment and issue resolution associated with process equipment commissioning, qualification and validation. 
• Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Drives for Right first time and continuous improvement execution, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time.
• Supports audits and observation improvements.
• Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Responsible for remaining current on assigned training.
• Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
• Ensures work requests are generated when issues arise with facility / manufacturing equipment.
• Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
• Ensure and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.

ROLE SUMMARY

The Bioprocess Technician IV drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule.  The Bioprocess Technician IV will work on interdisciplinary teams, to define and implement process improvements, and participate in process troubleshooting.

ROLE RESPONSIBILITIES

• Executes 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.
• Follow SOPs and batch records for unit operations
• Supports operation of manufacturing equipment and issue resolution associated with process equipment commissioning, qualification and validation. 
• Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Drives for Right first time and continuous improvement execution, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time.
• Supports audits and observation improvements.
• Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Responsible for remaining current on assigned training.
• Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
• Ensures work requests are generated when issues arise with facility / manufacturing equipment.
• Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
• Ensure and participates in performance of cleaning, inventory, and maintaining facility in a safe and