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.

Here Is What You Need (Minimum Requirements)

• High School Diploma or GED

• 6+ years of experience

• Experience within the biopharmaceutical industry, including knowledge and experience with relevant biopharmaceutical unit operations and/or laboratory operations

• Understanding of continuous improvement processes

• Proficiency in process equipment, systems, manufacturing operations, and automation control

• Ability to manage personal time and professional development

• Strong problem-solving skills with the ability to identify and resolve potential issues

Bonus Points If You Have (Preferred Requirements)

• Advanced knowledge of biopharmaceutical manufacturing processes

• Strong communication and interpersonal skills

• Familiarity with global regulatory and environmental guidelines

• Ability to adapt to changing priorities and work effectively under pressure

Physical / Mental requirements

• Requires the moving of heavy equipment and the ability to lift ~40 pounds.

• Moderate repetitive standing, sitting, bending, and ladder climbing on a daily basis.

• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.

• The incumbent is required to attain knowledge of the operational equipment.

• The incumbent will be required to assist in solving problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.