Process Optimization Specialist

4 hours ago


North Haven, Connecticut, United States Planet Pharma Full time
Job Title: Senior Process/Reliability Engineer

We are seeking a highly skilled Process/Reliability Engineer to join our team at Planet Pharma. As a key member of our organization, you will be responsible for overseeing and optimizing our Issues Triage and Investigation (ITI) processes.



Key Responsibilities:


  • Process Development & Optimization: Design, implement, and continually refine the ITI processes and cross-functional communication. Identify bottlenecks, inefficiencies, and areas for improvement.
  • Issue Monitoring & Analysis: Monitor reported issues across various sources. Categorize issues, identify trends, and analyze underlying causes to proactively address emerging problems.
  • Stakeholder Collaboration: Act as a central point of contact for teams across the organization, ensuring that process updates are communicated effectively, and all stakeholders are aligned.
  • Performance Monitoring: Regularly track and analyze process performance metrics (e.g., throughput, resolution times, error rates) to measure the effectiveness of current processes and identify opportunities for enhancement.
  • Compliance & Risk Management: Ensure all processes are compliant with FDA regulations, quality standards, and internal policies.
  • Training & Support: Provide training and support to team members on process improvements and best practices. Ensure that all staff understand their roles within the process and the importance of adhering to standards.
  • Cross-Functional Leadership: Lead and facilitate cross-functional meetings to address process improvements, drive initiatives, and foster collaboration among teams such as R&D, Manufacturing, Quality, and Field Service.
  • Documentation & Reporting: Develop, maintain, and update process documentation to ensure clarity and consistency. Provide regular reports to senior management on process performance, key metrics, and any necessary adjustments.
  • Trending & Predictive Analysis: Utilize data from reported issues to establish trends, predict potential systematic problems, and work with teams to implement preventive measures.


Requirements:


  • Education: Bachelor Degree/Master Degree in Biomedical Engineering, Computer Science, Electrical or Software Engineering.
  • Years' Experience: Senior – Bachelor Degree (4 yrs), Master Degree (2 yrs). Principal - Bachelor Degree (7 yrs), Master Degree (5 yrs).


Original Language Code: en

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