The Role:
- Senior MES Engineer
- Location: Galway
- Onsite role
- Permanent or Contractor opportunity
Role Brief:
The Senior MES Engineer will be responsible for providing onsite automation support to an NNIT Ireland client in the Med-Tech sector located in Galway. You will be responsible for working with a range of manufacturing systems in the manufacturing environment but with a strong focus on MES. The Debug, Configuration and validation of these systems will be a key aspect of the role.
Essential Duties and Responsibilities include, but are not limited to, the following:
- The design, debug, configuration, validation and management of manufacturing environment computerized systems.
- Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.
- Support of the configuration and validation of MES.
- Work on systems related projects as required to support overall manufacturing systems project requirements.
- Supports Validation Department with initial design review, software testing, and protocol review.
- Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
Skills Brief:
- 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 will be an advantage:
- Rockwell/Allen Bradley automation systems
- Vision Systems (Cognex Vision Pro)
- Ignition
- The following are essential:
- 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.
Person Brief:
- Candidates must have a level 8 degree in Computer Science / IT/ Pharmaceutical Manufacturing or a highly related discipline.
- 5+ years’ experience in a relevant role involving working with a diverse range of Pharma, Med-Tech, Life Sciences manufacturing software systems is essential – only candidates with this experience can be considered at this time.
- The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and able 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.
- The ability to be onsite daily is essential. Some remote working may be available, but the role is designated onsite and requires a full-time onsite presence. Therefore, you must be able to commute daily to the site.
As the role is designated as fully onsite you should be living within a reasonable commute of the Galway area or willing and able to relocate before your start date.
Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief:
NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT employs more than 1,800 people in Europe, Asia, and USA.