What are the responsibilities and job description for the Controls Engineer position at TekOne IT Services Pvt. Ltd.?
Process development, equipment specification, acquisition and implementation.
Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.
Supports on-site production and maintenance activities with advanced latter logic troubleshooting abilities
Serves as a steward of the internal QMS management system for change management (Oracle’s Agile PLM)
Integration of controls hardware and software into new and existing manufacturing equipment.
Design of experiments, validation, completion of testing and analysis of data.
Suggests and supports new methods or materials for continual improvement of quality and efficiency.
Analyzes current equipment for process suitability and provides detailed plans for improvement
Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures
Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary
Actively participates in teams as necessary to ensure continual improvement, safety and compliance
Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data
Must be able to use precision measuring equipment, hand and power tools
Must be able to meet deadlines while working on multiple projects
Familiarity with cGMP and ISO 13485 regulations and practices is desired
Familiarity with a variety of material testing and measuring methods
BASIC QUALIFICATIONS | EDUCATION:
Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
Minimum 3 years engineering experience in a manufacturing environment
Experience working in a GMP, FDA, ISO and USDA regulated environment preferred
Previous experience with common manufacturing automation technologies and architectures is required. This includes but is not limited to:
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