Engineering Specialist

hace 2 semanas


Insurgentes, México Novartis A tiempo completo

**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.



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