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Job Details
Novartis
Senior Project Engineer
Job Description
With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry!
Management of engineering technical projects, resources, costs and timelines in accordance with established scheduling and budget. Must be qualified to support cGMP engineering initiatives. Plans, estimates, budgets, schedules, and executes all aspects of project assignments including project scope, resource identification, capital and expense budgeting, project reporting, specifications, design, plan execution, factory acceptance testing, construction, installation, commissioning, documentation, financials, all aspects of system life cycle documentation (URS, FDS, FAT, IQ, OQ, deviation reconciliation), communications, reporting, and financial payments. Must be detail oriented, and possess and communicate a sense of commitment, ethics, urgency and practicality.
• Identify, review, scope and present project plans as required supporting manufacturing operations, compliance and quality, new product launches, facilities, business development, and the general business.
• Develop sustainable and robust plans. Present comprehensive and concise summaries. Approve funding requests, permitting, documentation and report progress in accurate and substantive summary.
• Manages entire project from assignment, concept through delivery and acceptance, supporting qualification and operational implementation. Review project proposal or plan to determine time frame, funding limitations, and procedures for accomplishing project, vendor requirements, and allotment of available resources to various phases of project.
• Meet with vendors to identify project deliverables, value, equipment, support, service, technology, project scope, scheduling, performance, documentation, and pricing as required.
• Coordinates with project team to develop and administer work plan and to develop roles, duties, responsibilities, and scope of authority. Works closely with validation to make sure that all required project documentation is relayed for appropriate project close out and commissioning.
• Reviews and provides approvals of all design, supplier, vendor specifications, documents and drawings associated with projects.
• Coordinates activities of project team including internal and external resources to ensure project progresses on schedule, within prescribed budget, and resolves technical service or technology issues.
• Research new technologies and provide production support for the ongoing and continuous operation of all manufacturing equipment. This may include travel to industry shows and expositions.
• Travels to perform Vendor Evaluations, Design Reviews, and Factory Acceptance Testing (FAT).
• Support and Meet Departmental, Plant and Corporate HS&E goals. Work in a safe and efficient manner.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flamma-ble, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour in-cident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
Management of engineering technical projects, resources, costs and timelines in accordance with established scheduling and budget. Must be qualified to support cGMP engineering initiatives. Plans, estimates, budgets, schedules, and executes all aspects of project assignments including project scope, resource identification, capital and expense budgeting, project reporting, specifications, design, plan execution, factory acceptance testing, construction, installation, commissioning, documentation, financials, all aspects of system life cycle documentation (URS, FDS, FAT, IQ, OQ, deviation reconciliation), communications, reporting, and financial payments. Must be detail oriented, and possess and communicate a sense of commitment, ethics, urgency and practicality.
• Identify, review, scope and present project plans as required supporting manufacturing operations, compliance and quality, new product launches, facilities, business development, and the general business.
• Develop sustainable and robust plans. Present comprehensive and concise summaries. Approve funding requests, permitting, documentation and report progress in accurate and substantive summary.
• Manages entire project from assignment, concept through delivery and acceptance, supporting qualification and operational implementation. Review project proposal or plan to determine time frame, funding limitations, and procedures for accomplishing project, vendor requirements, and allotment of available resources to various phases of project.
• Meet with vendors to identify project deliverables, value, equipment, support, service, technology, project scope, scheduling, performance, documentation, and pricing as required.
• Coordinates with project team to develop and administer work plan and to develop roles, duties, responsibilities, and scope of authority. Works closely with validation to make sure that all required project documentation is relayed for appropriate project close out and commissioning.
• Reviews and provides approvals of all design, supplier, vendor specifications, documents and drawings associated with projects.
• Coordinates activities of project team including internal and external resources to ensure project progresses on schedule, within prescribed budget, and resolves technical service or technology issues.
• Research new technologies and provide production support for the ongoing and continuous operation of all manufacturing equipment. This may include travel to industry shows and expositions.
• Travels to perform Vendor Evaluations, Design Reviews, and Factory Acceptance Testing (FAT).
• Support and Meet Departmental, Plant and Corporate HS&E goals. Work in a safe and efficient manner.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flamma-ble, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour in-cident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.