Operational Excellence Specialist

Job Description
Job Description: Operational Excellence Specialist
General Summary:
Operational Excellence Specialists are responsible for ensuring that device manufacturing operations are operating as efficiently and effectively as possible. They commonly work cross-functionally to identify opportunities for improvement, develop plans to implement those improvements, and track progress over time. Operational Excellence Specialists may also be tasked with developing new processes or procedures to help ensure consistent quality in the future.
Key Duties and Responsibilities:

• Implement improvements to operational processes using lean, six sigma methodology
• Supports compliance, and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
• Assists with the creation of GxP policies and procedures based on best practices
• Conduct analysis of operations through Root Cause Investigations to identify opportunities for improvement
• Reviewing performance metrics to identify trends that may indicate a need for change in operations
• Devise new strategies to improve operational efficiency and effectiveness
• Analyze data to identify patterns, trends, or problems that may indicate opportunities for improvement
• Work with management to develop action plans for addressing issues identified in operational analysis
• Educate employees about changes to processes to ensure that they are implemented effectively
• Recommend new processes or technologies to improve efficiency and reduce costs
• Participate in MES Electronic Batch Record Creation and other MES related activities
• Assist with the Development of OpEx Leads in each area
• Support the development of cross-functional team members on Lean Six Sigma tools and methodologies

Knowledge and Skills:

• Understanding of basic statistical analysis such as process capability/performance, control charting, and graphical analysis
• Excellent written and oral communication and presentation skills with the ability to speak and write effectively to all levels of the organization.
• Strong organization skills and attention to detail
• Able to apply critical thinking to analyze situation and determine the best course for action
• Ability to effectively capture stakeholders' needs and be able to summarize these into requirements and project scope.
• Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs.
• Ability to prioritize objectives from multiple projects, adhering to scheduled timelines while maintaining flexibility and efficiency.
• Understanding concept of MES and Electronic Batch Records

Education and Experience:

• 1-3 years of GMP experience or the equivalent combination of advanced education, and experience
• Lean Six Sigma certification (Yellow/Green Belt)
• Familiar with data analytics and visualization tools, such as Power BI, Visio, and Tableau
• Established Project Management Skills
• Competent with Microsoft Office

Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.