Automation Director

2 months ago

Alpharetta, United States CorDx Full time

About Us

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drug abuse, biomarkers and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Summary:

In the MD industry, an Automation Director is responsible for implementing automation technologies and ensuring all systems and processes meet MDSAP and other global compliance standards. Success in this role hinges on integrating ERP, OA, and automation equipment with regulatory standards, optimizing operational efficiency and compliance.

1. Responsibilities
  1. Automation Strategy and Compliance Implementation
    • Develop and implement an automation strategy that aligns with MDSAP requirements across production and quality control automation processes.
    • Identify and adopt automation technologies that meet industry regulations, such as ISO 13485 and FDA 21 CFR 820, ensuring compliance with global quality standards.
  2. ERP and OA Systems Integration
    • Oversee the selection, implementation, and integration of ERP (e.g., SAP, Oracle) and OA systems to streamline business and quality processes, ensuring seamless interaction with automation systems.
  3. Process Optimization and Continuous Improvement
    • Lead ongoing improvements in production and business processes, using automation technology and analytics to maximize efficiency, quality, and cost-effectiveness.
  4. Data Governance and Quality Control
    • Implement data management and governance strategies to ensure data accuracy in automation systems, providing real-time reporting to support MDSAP-compliant quality requirements.
  5. Cross-Department Collaboration
    • Work closely with quality, IT, production, and compliance teams to ensure automation systems and processes align with the quality management system (QMS) and global audit requirements.
  6. Compliance Monitoring and Internal Audits
    • Conduct regular system performance, compliance, and risk assessments to support MDSAP audits and ensure alignment with regional compliance standards.
  7. Employee Training and Culture Promotion
    • Promote internal training on automation skills, ensuring staff are proficient with MDSAP standards and company automation systems.
2. Workflow
  1. Identify and Assess Automation Needs
    • Identify automation needs in business and production areas, evaluating various automation solutions for compliance with MDSAP standards.
  2. Technology Integration and System Configuration
    • Ensure ERP and OA systems are configured to meet quality and regulatory requirements and are fully integrated with production automation and data analytics tools.
  3. Process Testing and Validation
    • Conduct tests and validations for automation processes to ensure compliance with ISO 13485 and FDA CFR 820, with a focus on quality control and data traceability.
  4. Monitoring and Reporting
    • Monitor system performance in real time, generate MDSAP-compliant reports, and regularly evaluate process efficiency and quality for data-driven improvements.
  5. Internal Audits and External Audit Preparation
    • Regularly perform internal audits to identify compliance risks, ensuring the organization is always prepared for MDSAP and other external audits.
3. Key Performance Indicators (KPIs)
  1. Production Efficiency Improvement Rate
    • Measure the improvement in production efficiency post-automation, aiming for reduced production time and costs.
  2. Quality Compliance Rate
    • Track the compliance rate of production and quality processes, aiming for 100% adherence to MDSAP, ISO 13485, and FDA standards.
  3. System Uptime and Failure Rate
    • Monitor automation equipment uptime and failure frequency to ensure continuous production and equipment reliability.
  4. Audit Pass Rate
    • Measure the company's pass rate in MDSAP audits, ensuring compliance with multi-market regulations.
  5. Data Accuracy and Report Timeliness
    • Assess the accuracy and timeliness of reports generated by the automation system, supporting data-driven decision-making and real-time monitoring.
  6. Team Training Completion Rate
    • Ensure the team completes regular training on automation and compliance, enhancing operational competency and supporting continuous improvement.
4. Essential Skills
  1. Technical and Systems Integration Skills
    • Expertise in integrating and configuring ERP (e.g., SAP, Oracle), OA, PLC (Programmable Logic Controller), and other automation systems, with a strong grasp of device connectivity and system optimization.
  2. Quality Management and Regulatory Compliance Knowledge
    • Proficiency in MDSAP, ISO 13485, FDA CFR 820, and other regulatory standards to ensure automation systems and processes align with global MD quality and compliance requirements.
  3. Data Analysis and Reporting
    • Skilled in data analysis tools (e.g., Power BI, Tableau) to generate automation reports and drive process improvements and decision support.
  4. Project Management and Continuous Improvement
    • Project management expertise (e.g., PMP certification) to lead cross-functional teams and implement automation and process optimization projects effectively.
  5. Team Leadership and Cross-Department Collaboration
    • Strong communication and team management abilities to train and lead teams, foster an automation culture, and enhance cross-departmental collaboration.
  6. Risk Assessment and Compliance Monitoring
    • Competent in risk assessment to identify and mitigate compliance risks related to automation, supporting MDSAP audit readiness and management.
  7. Education
    • BS/MS in a scientific (biochemistry, molecular biology, etc.), engineering (chemical, mechanical, etc.), or computational (computer science, etc.) discipline with 8+ years relevant experience.
  8. Proven experience in automation, quality management, or a related field.
  9. At least 5 years in a leadership or managerial role, overseeing automation projects and cross-functional teams.
  10. Experience in NetSuite or similar product experience.
Desirable Skills/Experience
  1. Experience in implementing change management initiatives and engaging organizations in new ways of working.
  2. Experience in complex project management and delivery.

Benefits:

  • Medical Insurance
  • Retirement Plan
  • Paid Time-Off
  • Opportunities for professional development and career advancement
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