MES Engineer

Orion Group Life Sciences are currently recruiting an MES Engineer on behalf of our Multinational Biopharmaceutical Client based in Mayo on an initial 12-month contract with potential to extend.
 
100% Onsite
 
Purpose

• Maintain the MES (POMSnet) environment; to author & maintain recipes & worksheets for the site.
• Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.

 
Responsibilities

• Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's 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.
• Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified.
• Liaise with Global MES on site required system improvements.
• 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.
• Cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
• Adheres to and supports all EHS standards, procedures and policies.

 
 
Requirements

• Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.

• A minimum of 2 years authoring experience preferably using POMSnet.
• Be familiar 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 an advantage.
• Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times.

 
 

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.