Job description
Responsibilities:
- Perform technical analysis activities, such as requirements gathering and performing gap analysis of user requirements against software functionality as well as defining Werum / Opcenter solutions and developing detailed design specifications.
- Define functional requirements through client interviews, documentation analysis and Workflow Process Mapping along with the development of Electronic Procedures and master recipes.
- Work with Process Controls, Manufacturing, Quality Control Labs, SAP and I.T. organizations regarding the development and implementation of System interfaces.
- Provide expert knowledge and experience to estimate the technical effort and cost required to implement complex solutions as well as proactively reporting on project progress against schedules.
- Participate on technical and business project teams, ensuring that effective relationships are built and maintained being responsible for technical deliverables during the entire lifecycle of development projects
- Responsible for ensuring cGMP/Regulatory compliance with internal/external policies, guidelines; these include internal SOP’s, departmental standards and conventions.
- Interact with external organizations, consultants and vendors as required in the successful accomplishment of project assignments.
- Available for after-hours calls to assist both operations and controls support with production issues.
Qualifications:
- Bachelor’s Degree: preferably in Computer Science, MIS, Engineering, Operations, Business, or equivalent knowledge
- 2 - 6 years industry experience in systems or process development, programming, process automation, Operations, or engineering discipline
- 4 - 6 years’ experience working within MES applications (Manufacturing Execution Systems)
- Experience with one or more of the following systems a plus – Werum, Opcenter, Syncade, Rockwell FTPS, or implementing MES applications
- Preferred Pharma/Biotech industry experience
- Understanding of Standard Microsoft Office and Productivity tools
- Familiarity with S88/S95 General principals
- Preferred understanding of MES Software (Werum, Opcenter), Interfaces to DCS/OPC, ERP, LIMS, and Document Management.
- Understanding of business and manufacturing logistics.
- Exposure to MES technologies, including automated data collection, historian applications (OSI PI a plus). SCADA, automated decision control, workflow, database applications, and interface to ERP and LIMS systems
- Exposure to enterprise level large-scale applications
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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