Sr Biologics Production/Project Analyst
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| Job Type | Permanent |
| Area | Mayo, IrelandSligo, IrelandDublin, IrelandCork, Ireland |
| Sector | EngineeringOperations & Manufacturing |
| Start Date | |
| Advertiser | Esther Emmanuel |
| Telephone | +3539833033 |
| Job Ref | 2604 |
| Job Views | 178 |
- Description
- Sr Biologics Production/Project Analyst - Team Horizon
We are excited to invite experienced and driven candidates to apply for the Senior Biologics Production/Project Analyst opportunity here at our client’s site.
As Senior Biologics Production/Project Analyst you will support Global Engineering Projects from an aseptic Operations perspective. You will work closely with cross functional teams including but not limited to S&T, R&D, Quality, Validations, and external design companies to support the development and qualification of commercial manufacturing suites to support the Business needs.
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:
Define equipment listings and specifications to support aseptic processing operations
Development, review and approval of personnel, material, product and waste flows to support design of new facility layouts for aseptic processing operations
Development, review and approval of Operational Process Maps for batch manufacturing to support the design of facilities, utilities and equipment for aseptic processing operations. Understanding the CPPs within the process and their link to the CQAs of the product.
Creation of finite schedules for batch manufacturing processes to support equipment design and capacity planning
Development of single use systems for Mixing and Filling equipment for aseptic processing operations
Support Aseptic Filling Trials for NPI’s
High level of input into DFMEA & PFMEAs for facility, equipment and processes.
Execution of design reviews and FATs at vendor sites to ensure equipment meets the process and end-user needs
Review, approval & execution of commissioning and qualification activity to (IQ/OQ/PQ)
Execute feasibility studies on current equipment as needed in compliance with the quality management systems
What you need to apply:
Bachelor’s degree in Science/Engineering or equivalent.
Minimum 3 years’ experience in the Pharmaceutical/Biopharmaceutical industry
Minimum 3 years Knowledge/Experience of working within a clean room manufacturing department
In depth knowledge/experience in Operations requirements for compounding processes, autoclaves, filling machines, filter/glove integrity testing, single use systems within an aseptic processing environment
Competent in Word, Excel, PowerPoint, Visio, CORAL, Track wise, SAP
Good interpersonal and communication skills essential for working across multi-functional teams.