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.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
• Bachelors Degree in Engineering is required (prefer Mechanical Engineering or Chemical Engineering).
• 3+ years of relevant manufacturing/engineering experience is required.
• Previous pharmaceutical manufacturing experience is required.
• Comprehensive technical knowledge of pharmaceutical equipment and plant design is required.
• Experience with pharmaceutical industry standards and requirements (Minimum US GMP) is required.
• Basic knowledge of validation processes is required.
• PE Certification a plus
• Understanding of business systems (SAP, LIMS etc.) is required.
• Familiar with Engineering software systems (CAD, project management, maintenance management and calibration) is required.
• Highly PC literate in Microsoft office suite is required.
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877) 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.