Operations Technical Support Specialist
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| Job Type | Permanent |
| Area | Mayo, Ireland |
| Sector | EngineeringOperations & Manufacturing |
| Start Date | |
| Advertiser | Esther Emmanuel |
| Job Ref | 2735 |
| Job Views | 84 |
- Description
- Team Horizon - Manufacturing Support Specialist
We are currently sourcing an experienced Manufacturing Support Specialist to join our client’s Biologics Operations team in Co. Mayo.
In this role you will have overall responsibility for Batch Records, Recipes, and the Process in the Biologics Manufacturing business unit.
Working closely with other functions, you will be responsible for the delivery of production objectives related to the end-to-end manufacture of products and New Product Introductions.
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.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Successful execution of Product batches and campaigns from a Safety, Quality, Supply and Financial perspective
Ownership of Recipes and Batch Records related to Products
Ownership of Manufacturing Instructions, ensuring Shift Operations Colleagues have standardized and robust instructions in place to enable RFT execution of Product manufacture
Ensuring Aseptic Manufacturing requirements and Product specific requirements are met through detailed Manufacturing Instructions and Equipment Configuration / Set-Up
Delivery of Risk Assessment tools, such as FMEA, to ensure successful campaigns
Supporting Operations Shift Teams in day-to-day execution
Leading of relevant Investigations and Troubleshooting
Driving RFT execution of manufacturing through delivery of Continuous Improvement initiatives
Oversight of Inventory management for Products under responsibility
Trending of Quality Performance of Products
Trending of Yield performance and delivering projects to optimze Yield performance
Assisting in the execution of Equipment Manufacturing activities
For New Products, following all Technology Transfer Procedures to ensure a successful transfer and manufacture of the New Product process
What you need to apply:
You will have a bachelor’s degree or equivalent required in an engineering or Science related field
At least 3 years’ experience in all aspects of manufacturing/production processes with good writing skills
A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation
Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
Intermediate to High computer and MS Office skills.