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Manufacturing Batch Record and MES Specialist
2 months ago
About Us
At Teva Pharmaceuticals, we are dedicated to enhancing the lives of over 200 million patients daily and billions annually. Our commitment to providing high-quality healthcare and medications is unwavering. We are currently seeking a Manufacturing Batch Record (MBR) and Manufacturing Execution System (MES) Designer to join our dynamic team.
Our Runcorn facility focuses on the development, production, and marketing of innovative and cost-effective medications, particularly in sterile liquid formulations for respiratory conditions, utilizing advanced Blow-Fill-Seal technology and injectable Combination Products.
Role Overview
The primary objective of this position is to ensure system excellence for MBRs and MES within our operations. This encompasses all aspects of Pre-filled Syringes (PFS) and Blow-Filled Seal (BFS) processes. The successful candidate will be responsible for updating and designing new configurations within the MES system to ensure alignment with Standard Operating Procedures (SOPs) governing the production of our pharmaceutical products. Additionally, the role involves managing master data within the MES and supporting ongoing operational development.
Key Responsibilities:
- Revise MBRs in the MES system for both existing and new products in accordance with approved production documentation.
- Modify MBRs to incorporate functionalities based on site-specific requirements.
- Assess product change controls and their implications on MES and MBR.
- Conduct validation for system upgrades and updates to SOPs and Work Instructions (WIs).
- Create and update SOPs and WIs for the MES.
- Facilitate training for both new and existing personnel.
- Actively promote a culture of safety on-site by reporting safe and unsafe conditions through appropriate channels.
- Assist in root cause analysis for troubleshooting purposes.
Candidate Profile
We are looking for individuals who possess:
- A degree in a relevant field (engineering, IT, or scientific disciplines) is preferred but not mandatory.
- Experience with ERP systems, particularly SAP manufacturing processes.
- Practical knowledge of MES, operations, and design principles.
- Experience in the pharmaceutical sector or another highly regulated industry related to business processes.
- An understanding of IT system lifecycles in GxP environments and the IT system validation process.
Are you:
- A strong communicator, motivator, and team player?
- Capable of achieving high performance standards?
If you meet these criteria, we would be interested in your application.
