Job Description

Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you\'ll help bring medicines to the world even faster by imagining what\'s possible and taking action. What You Will Achieve Working with Pfizer\'s dynamic engineering team, you will play a critical role in the design and development of manufacturing processes to bring products from research to manufacturing. You will leverage your technical capabilities to understand the inherent problems of transfer of technology from the research stage to manufacturing, in cooperation with pilot-plant and production departments. You will conduct tests and measurements throughout the stages of production and troubleshoot production process problems with processes or equipment already in operation. As a manager, your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of engineering, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. 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 Solution Preparation Process pharmaceutical experience Practical experience in facilitating and conducting risk assessments Strong mammalian cell culture expertise required, knowledge of other heterologous expression systems Role Summary Provide Solution Preparation Equipment engineering subject matter expertise for Pfizer\'s state-of-the-art, large scale injectables facility located in Vizag, India The Solution Preparation Equipment 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 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 Solution Preparation 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 successful completion of project objectives The Solution Preparation Equipment Engineer is responsible for providing technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies if required. Support development of a world-class sterile injectables manufacturing site at Vizag by providing Solution Preparation Equipment and Technology expertise The scope of equipment includes Solution Preparation Equipment (CIP Skid, PW vessels, WFI vessels, CIP distribution system, mix vessels, Holding Vessels, Transfer Panels and Product transfer Panels, Portable Stations, Hot WFI distribution systems) 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, requalification 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 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 requirement of the Maintenance and Manufacturing operators and develop, in collaboration with the OEMs as required, appropriate and tailored training plan. Provide technical training on process 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 spares availability through the equipment lifecycle Own the equipment drawings, P&IDs and act as the primary link into 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 improvement 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 to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required. Lead/ represent Solution Preparation Equipment 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 site during shifts, to provide technical help during any equipment emergency Adhere to safe work practices, example clean room gowning a) this position leads investigations within boundaries of responsibility i.e. TS Block, supports the Investigation lead for coordination with other cross functional teams. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Engineering

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