Job Overview
We are seeking a highly skilled Senior Manufacturing Engineer to join our client, a global leader in the biopharmaceutical industry.
The ideal candidate will have a strong background in manufacturing engineering, with experience in authoring and maintaining recipes and worksheets using MES systems.
The successful candidate will be responsible for designing, creating, writing, and executing protocols, risk assessments, and system documentation.
They will also ensure cleaning, equipment, and product procedures are aligned to MES processes and vice versa.
Key Responsibilities:
1. Design, create, write, and/or make all required changes to MES Recipes, worksheets, equipment, and material spec's 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 are aligned to MES processes and vice versa
4. Provide training for all other site personnel on their related MES roles and arrange system access
5. Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds, and fixes identified
Requirements:
* Third Level qualification in suitable manufacturing, engineering, or business course and/or suitable experience
* A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects
* Be 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
What You Will Be Doing:
1. Design, create, write, and/or make all required changes to MES Recipes, worksheets, equipment, and material spec's including phase transition logic
2. Design, create, write, and execute, test, and validation protocols, risk assessments, and system documentation
3. Design, create, write, and/or make all required changes to ensure cleaning, equipment, and product procedures are aligned to MES processes and vice versa
4. Provide support to other MES system users as required to ensure business continuity
5. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration
Why You Should Apply:
This is an excellent opportunity to join a world-class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.