**Summary**:
The engineering specialist will help with day-to-day engineering tasks needed to support manufacturing sitefocusing on activities that can be performed remotely. Role will support automation, Commissioning & qualification, process and utility engineering and maintenance functions.
**About the Role**:
**Major accountabilities**:
**Responsibilities**:
- Work order review
- Validation Periodic reviews of equipment systems
- System user reviews
- 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
**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
**Languages**:
- English Proficiency
Division
Operations
Business Unit
Innovative Medicines
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
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Engineering Specialist (Baja California Sur)
🏢 Novartis
📍 Baja California Sur