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

Use Your Power for Purpose

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 Pfizer’s 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

• Leads 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.
• 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, the timely review of daily documentation and completes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
• Partners with area Process Engineer for audits and walkthroughs and observation improvements, as needed.
• 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.
• Leads and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.
• 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.

ROLE SUMMARY

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

ROLE RESPONSIBILITIES

• Leads 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.
• 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, the timely review of daily documentation and completes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
• Partners with area Process Engineer for audits and walkthroughs and observation improvements, as needed.
• 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 escal