Manager – Equipment Technology ( Filling Line SME) | Pfizer | Vizag

Job Description

Role Summary

• Provide Filling line equipment engineering subject matter expertise for Pfizer’s state-of-the-art, large-scale injectables facility located in Vizag, India
• The filling line equipment engineer is responsible for providing engineering technical and equipment qualification support to the operating unit ensuring that the equipment is running as intended and that all equipment issues are resolved to support the manufacture and timely disposition of the product
• This role focuses on leading and resolving technical issues within the Operations Unit, implementation of CAPAs and equipment improvements, support generation of product impact assessments, providing routine technical support and troubleshooting, investigation closeout, and maintaining the qualification status of the physical plant and equipment.
• The filling line equipment engineer is responsible for Project Management/ execution of assigned projects (short duration), which includes the management of internal company resources (assets financial, and personnel), external Engineering, and vendors as part of the execution of projects. The direct management responsibility includes all support activities and functions necessary to ensure the successful completion of project objectives
• The Filling line equipment engineer is responsible for providing technical expertise during audits and also to present/defending engineering systems, applicable change controls, investigations, and equipment qualification packages to the regulatory agencies if required.
• Support the development of a world-class sterile injectables manufacturing site at Vizag by providing Filling line equipment engineering and Technology expertise
• The scope of equipment includes: Filling line equipment (Vial Washing machine, Vial Depyrogenization Tunnel, Vial Drying Tunnel, Vial Capping machine, Tray loading equipment, Vial De-packing equipment) and Particle Counting machine Online/Off-line and Portable equipment (Weighing balances, Filter Integrity Machine, Particle counter machine, Headspace analyzers)

ROLE RESPONSIBILITIES

• Ensure all equipment installed is safe, effective, and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical support in periodically reviewing Preventive/Predictive Maintenance programs, in collaboration with the maintenance manager, to improve the operational reliability of the equipment
• Lead major investigations into equipment and/or process failures and implement equipment CAPA and performance improvements.
• Review and approve documentation for cGMP validation, prequalification, and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols, and reports to maintain the equipment in a validated state.
• Write product/process impact assessments in support of investigation closures
• Provide routine equipment technical support and troubleshooting for the resolution of manufacturing issues
• Work with the Maintenance and operation managers to develop competency improvement projects and tasks to up-skill the Manufacturing and Technician teams.
• Support assessing training requirements of the Maintenance and Manufacturing operators and develop, in collaboration with the OEMs as required, appropriate and tailored training plans. Provide technical training on processes and equipment in collaboration with OEMs, as required.
• Own the relationship with key vendors for the assigned equipment through this relationship speed up troubleshooting and fault-finding responsiveness, improve equipment and spare availability through the equipment lifecycle
• Own the equipment drawings, and P&IDs and act as the primary link to the Automation team for the assigned equipment sets
• Capacity and Reliability improvement projects delivered on time, within cost, and meet the specifications/requirements of the Operating Unit.
• Undertake continuous improvement projects to improve the performance or output of the assigned equipment: Identify equipment improvements and develop these into project scopes, this may also include progressing to funding approvals.
• Work with the Reliability Engineer to get source data on equipment performance with a view to driving system improvements
• Review all documents in relation to all improvements and upgrades.
• Own and implement Change Controls and assigned CMTs
• Provide technical expertise during audits and also present/ defend engineering systems, applicable change controls, investigations, and equipment requalification packages to the regulatory agencies if required.
• Lead/ represent Filling equipment engineering on short-duration project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost, and schedule are adhered to.
• Work to implement a culture of Right-First Time through partnerships with Operations and other Engineering functions
• Support the design and selection of process & ancillary equipment.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to prioritize & manage a variety of activities at the same time
• Good understanding of customer expectations and deliverables

NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS

• Ability to visit the site during shifts, to provide technical help during any equipment emergency
• Adhere to safe work practices, for example, clean room gowning

Interactions with this position: (a) this position leads investigations within boundaries of responsibility i.e. TS Block, supports the Investigation lead for coordination with other cross functions

Qualifications

Must-Have

• Bachelor’s degree in Engineering (Mechanical / Chemical / Electrical / Instrumentation)
• 8-10 years of experience in fill finish (injectables) pharmaceutical industry
• Knowledge and understanding of the US cGMP (21 CFR Parts 210, 211)
• Understanding of the local safety and environmental regulations
• Understanding of electronic batch records and electronic signatures (21CFR Part 11)
• Ability to communicate with site & corporate global functions
• Well-versed with industry best practices and guidelines such as those with ISPE, PDA, ASME, etc.

Nice-to-Have

• Master’s degree
• Relevant pharmaceutical experience
• Practical experience in facilitating and conducting risk assessments
• Strong mammalian cell culture expertise is required, as knowledge of other heterologous expression systems