Engineering Specialist

Engineer Execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost effective technical solutions, ensuring technical quality to enable the overall site / project objectives .Maintenance Technician II Responsible for execution of maintenance And calibration activities and commissioning activities for projects at site level. Process Engineer Supervise plant engineering team providing technical assistance to the function and ensuring that the best possible maintenance, repair and/or modifications are undergone.

Location: CDMX

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

Key responsibilities:

• Work order review. Validation Periodic reviews of equipment systems
• System user review. Create and revise engineering owned SOP's.Periodic reviews of engineering owned documents. Deviation and CAPA ownership and support .System alarm trending and reporting and any associated investigations
• Perform and conduct risk assessments. Equipment KPI metric generation. Change control ownership and action item ownership
• Audit trail review. Engineering library management including maintaining the Validation Document Equipment Lifecycle Index Site facility drawing updates and management
• Project administration and associated metrics. Maintain Engineering dashboards. Manage workload to ensure timely approval of validation testing and documentation. Support the engineering department during inspections or audits. Build productive internal/external working relationships
• Manage end-to-end document workflows for all types of engineering documents. Exercise good judgment within defined procedures and practices to determine appropriate action .Update and manage all engineering design and project documentation using AutoCAD, Revit, BIM, Navisworks, Etc.
• Maintain and update all engineering specifications, standards, and design information, including building information modeling data
• Other related duties as assigned

Essential Requirements:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 2 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (6 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations in lieu of degree
• Solid foundation in FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility
• Excellent English oral and written communication skills. Strong technical writing ability required
• Experience with full Autodesk CAD suite
• Proficient in Microsoft Word, Excel, PowerPoint, Teams, and Project Knowledge of equipment and computerize system validation concepts

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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Division

Operations

Business Unit

Production / Manufacturing

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.