About the Role:
You will be responsible for providing onsite automation support to clients in the Med-Tech sector as a Senior MES Engineer.
Key aspects of the role include design, debug, configuration, validation and management of manufacturing environment computerized systems.
Essential duties and responsibilities include but are not limited to:
1. Design, debug, configuration, validation and management of manufacturing environment computerized systems.
2. Presentation of status reports, metrics identification of trends potential issues, improvement initiatives as applicable.
3. Support of the configuration and validation of MES.
4. Work on systems related projects as required to support overall manufacturing systems project requirements.
5. Supports Validation Department with initial design review software testing protocol review.
6. Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
Key Skills and Qualifications:
The candidate must have strong proven experience with configuration, validation and implementation of manufacturing systems software. Level 2 Automation Integration ISA-88 / PackML and Overall Equipment Effectiveness (OEE) Network Architecture including industrial network protocols Experience developing in Visual Basic (VB) in MES environment.
Proven knowledge and experience with one or more of the following Rockwell Allen Bradley automation systems Vision Systems Cognex Vision Pro Ignition are advantageous.
Requirements:
Demonstrated analytical and problem-solving capabilities full understanding of cGMP requirements including 21 CFR 11 and Annex 11 excellent understanding of GAMP principles systems implementation and validation concepts strong technical writing skills.
A level 8 degree in Computer Science IT Pharmaceutical Manufacturing or a highly related discipline is essential along with 5+ years experience in a relevant role involving working with diverse range of Pharma Med Tech Life Sciences manufacturing software systems.
Personal Qualities:
Excellent collaboration and communication skills strong attention to detail ability to communicate and present effectively to various levels of leadership ability to think logically and be proactive strong problem-solving skills and work well as part of a team or on their own initiative.