This person is responsible for analyzing and supporting manufacturing systems. This requires broad end-to-end knowledge of the manufacturing processes from different perspectives including the operators, quality engineering, process engineering etc. Systems which are currently being used include Siemens Opcenter (formerly Camstar), MasterControl, and others.
• Execute projects to maintain and improve data and information contained within MES and ERP systems.
• Analyzes and understands CBI’s business needs, and translates those needs into supporting business cases and implementation in Opcenter.
• Models and configures manufacturing processes in Siemens Opcenter
• Working mastery or ability to quickly gain mastery of Opcenter.
• Willingness to gain mastery of other key CBI systems and processes.
• Use, demonstrate competence with, and collaborate via continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen).
• Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties (knowledge of software validation requirements including CFR 21 part 11 in particular)
• Seek new skills/knowledge relevant to CBI.
• Share relevant knowledge with other CBI employees.
• Analyzes and understands business needs from an end-to-end perspective, taking into account other MES, ERP, and internal projects.
• Inform management of key decisions.
• Presents analysis, findings, and key questions to management in a structured way.
• Partners proactively with key internal customers, stakeholders, and team members
• Listen to ideas and concerns from production, colleagues, and management.
• Communicate effectively with production, colleagues, and management.
• Relentlessly eliminate waste from processes by evolving particularly the MES and ERP systems.
• Demonstrate mastery of writing and documenting activities in the medical device industry.
• Demonstrate mastery of presenting information appropriate to the receiving audience.
• Conduct other corporate duties when required.
• BS in computer science, manufacturing engineering, or relevant field
• 2+ years of Opcenter (Camstar) work experience and MES process understanding preferred
• Knowledge of Structured Query Language (SQL)/Oracle concepts preferred
• Able to set goals for self and work to achieve milestones
• Able to work effectively on multiple projects simultaneously
• Able to effectively communicate with others
• Excellent record keeping and documentation skills
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology
Physical Requirements/Work Environment
• Must be able to perform the essential functions of the job, with or without reasonable accommodations. Physical demands are typical of an office environment.
• Willing to perform other corporate duties when required