Senior MES Engineer Role at Global Leader in Biopharmaceutical Industry
About the Role
Maintain the MES (POMSnet) environment, author and maintain recipes and worksheets, and provide technical guidance to other MES Engineers.
Act as site escalation point for complex or challenging troubleshooting or recipe design.
Provide project management guidance and expertise to the MES function.
Why You Should Apply
This is an excellent opportunity to work in a world-class manufacturing operation with a strong track record of delivering high-quality medicines globally.
A culture of continuous improvement and innovation strives for solutions that improve health outcomes and dramatically impact lives.
The company is developing its capability to produce all medicines, ensuring continuity of supply as it expands internationally.
Key Responsibilities
1. Design, create, write, and make required changes to MES Recipes, worksheets, equipment, and material specs, including phase transition logic.
2. Design, create, write, and execute test and validation protocols, risk assessments, and system documentation.
3. Ensure cleaning, equipment, and product procedures align with MES processes and vice versa.
4. Provide training for other site personnel on their related MES roles and arrange system access.
5. Liaise with Global MES on site system improvements and provide support to other MES system users.
6. Participate in NPI projects from initiation, considering MES system or hardware requirements.
Requirements
* Third Level qualification in manufacturing, engineering, or business course and/or suitable experience.
* A minimum of 7 years authoring experience and leadership/technical lead on multiple implementation projects.
* Proficiency in MES application and configuration rules, including interfacing (preferably POMSnet).
* Experience in batch processing operations in an FDA/HPRA regulated industry.
* Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
* Good knowledge of IT systems and SAP knowledge/experience in MM, PP, and IM modules.
* Proven attention to detail and mental concentration to ensure total compliance with procedures.