Senior Associate, Calibration & Maintenance CRD-M

Why Patients Need You
 

The success of our breakthroughs reaching patients is a testament to our pharmaceutical manufacturing team. We depend on a group of committed and nimble individuals who grasp the significance and influence of their contribution to Pfizer's mission. Patients require colleagues who are proud of their work and constantly strive to enhance results. Your role is crucial in guaranteeing that patients and physicians receive the necessary medicines at the right time.

Position Summary
 

The Senior Associate, Calibration & Maintenance CRD-M supports the Chemical Research and Development Manufacturing (CRD-M) Team in Groton, CT.  This role is part of Pfizer R&D and has primary responsibility for the planning, scheduling, and execution tracking of the CRD-M Calibration and Maintenance Program.  This role will report to the Compliance & Manufacturing Support Lead.

As the Senior Associate, Calibration & Maintenance CRD-M you will be responsible for coordinating and collaborating with staff from CRD-M, Drug Product Supply Manufacturing, Global Workplace Experience, and other relevant groups to ensure the timely execution of cGMP and EHS compliant Calibration and Maintenance activities. This includes managing Work Order Planning, scheduling, assignment, and review. A critical duty of this role is the monitoring of Calibration and Maintenance program health through the development and reporting of metrics. Additionally, this position requires managing Manufacturing Investigations and Change Management related to calibration and maintenance, as well as the creation of Standard Operating Procedures (SOPs). The role involves direct interaction with support lines and the use of Pfizer's software tools (EAMS, eQMS, Trackwise, GDMS, etc.) to perform these tasks.

Role Responsibilities

• Maintain current knowledge of regulatory requirements and the Pfizer compliance environment to be able to perform activities defined above and provide asset management guidance to key stakeholders.

• Develop and maintains robust working relationship with Manufacturing, Engineering, and Quality support groups.

• Serve as the primary CRD-M EAMS superuser and EAMS Maintenance Engineer access role.

• Develop, extract and report metrics/ key performance indicators to measure program health and compliance.

• Collaborate with CRD-M Management to coordinate calibration and maintenance activities around manufacturing schedules and facility shutdowns.

• Responsible for the timely completion of quality incident investigations, including root cause determination and effective Corrective and Preventative Action determination.

• Author Standard Operation Procedures.

• Participate in equipment and computer system validation lifecycle activities to include commissioning, qualification, periodic review, retirement, and change management.

Qualifications

• Associate's degree and minimum 6 years’ related experience.

• Direct, functional experience with<