Senior Team Leader - Instrumentation

Use Your Power for Purpose
At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.
Role Summary:
Senior Team leader will have responsibility for managing regulatory aspects of the Building Management System (BMS), Environmental Monitoring System (EMS), Particle Monitoring System (PMS), Temperature Monitoring System (TMS) and Utility control systems used in the manufacture of sterile injectables. This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of the Instrumentation/Control systems within a sterile injectable manufacturing facility.
What You Will Achieve

• Support the operation and troubleshooting of Building Management System (BMS), Environmental Monitoring System (EMS), Particle Monitoring System (PMS), Temperature Monitoring System (TMS) and Utility control systems.

• Maintenance of PLCs, DCS, SCADA and various Electronic field instruments and sensors

• Instrumentation/Control Systems are maintained in good condition and minimize downtime.
• Support reliability engineering for production and support equipment
• Trending equipment failures / breakdowns and propose corrective actions
• Carrying out modifications for improvement of the machine/ equipment performance
• To guide the team during breakdowns, trouble shooting and rectifying the basic causes in shortest possible time and also ensuring the data is captured in CMMS.
• Responsible to complete the preventive maintenance of the BMS, EMS, PMS, TMS & Utility Control Systems.
• Ensure all the team performing operation and maintenance of equipment / instrument are trained on relevant procedures
• Ensure good housekeeping in the area of work
• Constantly working with other cross functional teams to understand the improvements in terms of BMS, EMS & PMS and leading the required modifications by guiding his team members
• Assist other departments in evaluating historical process/equipment data
• Study & review operations, to contribute substantially for energy conversation & productivity improvements.
• Support FAT/commissioning/qualification activities as required
• Review qualification protocols of automated systems.
• Support the execution of the qualification of automated control systems.
• Prepare risk assessments for automated systems
• Responsible for Periodic review of the BMS, EMS, PMS, TMS & Utility control systems with support of validation team.
• Design and implementation support for functional and process changes, either smaller projects, remediation activities, Control Systems upgradation projects or capital projects.
• Support future capital projects and assure site automation standards are followed
• To identify continuous improvement initiatives (process improvement, energy efficiency, etc.) and ensuring to implement them
• To prepare monthly reports, annual expense statements etc.
• To prepare departmental budget and control the expenses within approved/ sanctioned limits.
• Review of equipment breakdown data
• Support Investigations, identify root causes and suggest CAPAs
• Generate user requirement specifications for control systems.
• Author and/or review design documents for projects and process changes
• Review vendor automation design documentation (FS, HDS, SDS, DDS, requirements traceability matrix, code and logic, etc.).
• Ensure the activities being carried out in the BMS, EMS, PMS, TMS & Utility control systems are in line with the approved procedures
• Prepare Change Controls associated with changes to control systems
• Ensuring on time closure of change control and CAPA action items Change controls management.
• Develop procedures to comply with guidelines.
• Review and approval of GMP / Quality documents & procedures
• Implement cGMP and ensure compliance with laid down SOPs, Quality Systems, Safety Systems at all stages of activity
• Extending required support during Walkthroughs, Internal Audits & Regulatory Audits
• Ensure all relevant Procedures like Standard Operating Procedures & Testing Procedures and other procedures are in place and being followed.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering