- Entry level
- No Education
- Salary to negotiate
This role will be responsible for developing, establishing, and maintaining the Engineering Documentation System in a manner that ensures all identified technical documentation is inventoried and available to reflect the current status of all current equipment and processes on site.
• Provides oversight and guidance to sustain compliance with Regulatory, Corporate and Site GMP processes for Engineering documentation, which includes all change controls, validation, com-missioning, deviation, SOPs, capital project files, and drawing, documents.
• Accurately maintains the on and off site controlled filing storage systems for current and historical records. Develops and maintains appropriate policies and/or procedures to be applied to all Engineering documentation regardless of source, location, or media type.
• Controls lifecycle documents within scope of department such as SOPs, forms, technical reports, Validation Protocols and Reports, and drawings.
• Ensures that any revisions or updates are executed and recorded in accordance with procedure. The Engineering documentation controller also facilitates the retrieval and reproduction of Engineering documentation for Engineering and other site groups as necessary.
• Responsible for the coordination, control, storage, copying and retrieval of all Engineering Documentation. Develops, classifies, and reviews record retention schedules for Engineering Documentation. Periodically reviews and updates retention schedules to reflect changes in legal and/or operational requirements.
• Provides education and awareness to site employees regarding Engineering Document System and the documents available in the system
• Maintains database tracking system for Engineering Documentation. Coordinates and maintains curricula and other training elements of the Engineering Group.
• Audits Engineering SOP’s, document types, and training records to ensure compliance.
• Participates in all inspections and internal / external audits by facilitating document access and as assigned.
• Collaborates with Director Engineering, Validation Manager, and Manager, Engineering and other functional representatives for document prioritization.
• Maintains ACAD drawings to ensure redlines are updated on official drawings and incorporated into the site Critical Drawing Book as appropriate.
• Coordinates and tracks all department Trackwise actions and functions as lead deviation writer for the Engineering department.
• Performs other duties as assigned Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
4 years related experience
Auto CAD experience preferred
Fluent in written and spoken English Experience
Division Novartis Technical Operations
Business Unit NTO SOLIDS
Site Wilson, NC
Company/Legal Entity Eon Labs Inc
Functional Area Quality
Job Type Full Time
Employment Type Regular
About the company
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Our company culture is guided by high ethical standards. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.