OverviewThe successful candidate will be responsible for the maintenance of the Manufacturing Execution System (MES) environment. This is a POMSnet system and you will author and maintain recipes and worksheets for the manufacturing site using the POMSnet system. You will also provide technical guidance and solutioning to other MES Engineers and act as site escalation point for complex or challenging troubleshooting or recipe design. Furthermore you will provide project management guidance and expertise to the overall MES function.
Core Tasks
Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material specs including phase transition logic
Design, create, write and execute, test and validation protocols, risk assessments, and system documentation
Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa
Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access
Provide support to other MES system users as required to ensure business continuity
Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration
Keep other recipe authors up to date on MES changes
Documentation of all activities in line with cGMP requirements
Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems
Skills Brief
Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience
A minimum of 5 years authoring experience using POMSnet
You must be able to provide evidence that you have led or were a technical lead on a number of key implementation projects
Be highly proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet)
Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
A good knowledge of IT systems is required for this role
SAP knowledge/experience in MM, PP and IM modules is a requirement
Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times
Person Brief
Candidates must have a B.Sc. Degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 3 years’ experience in industry, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment. The ideal candidate will have excellent communication & problem solving skills as well as strong stakeholder & vendor management skills.
As this role is fully onsite in County Mayo and the successful candidate must be based in County Mayo or within a reasonable commute. Only candidates with a current valid work permit to work in Ireland can be considered due to project timelines.
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.
About NNIT
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 consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and USA.
We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.
In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.
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