Senior Continuous Improvement Specialist II

Senior Specialist, Operational Excellence & Data Analytics

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

Join a team where your expertise will directly support operational excellence in a highly regulated pharmaceutical manufacturing environment.

This role combines operational excellence, manufacturing support, and data analytics to improve process performance, streamline workflows, and enhance manufacturing execution. You'll partner with cross-functional teams to implement Lean methodologies, optimize production processes, support manufacturing documentation, and leverage data to drive informed decision-making throughout the organization.

• Lead and support continuous improvement projects aimed at optimizing manufacturing processes, enhancing quality, and reducing costs.
• Identify and implement process improvements related to resource coordination, documentation flow, process performance, and inventory management.
• Facilitate Kaizen events, workshops, and training sessions to promote a culture of continuous improvement.
• Collaborate with cross-functional teams to implement Lean manufacturing tools and techniques, such as 5S, Six Sigma, and lean inventory management methods.
• Collaborate with Manufacturing Supervisors to manage and analyze production data and equipment performance.

• Ensure availability and distribution of production documentation including batch records, logbooks, and other manufacturing documentation.
• Perform real-time review of production documentation for compliance and accuracy.
• Collaborate with Quality Assurance and Document Control to manage document life cycles and ensure current document versions are available for production.
• Update manufacturing documentation, including Standard Operating Procedures (SOPs), Batch Records (BRs), and forms.

• Partner with Supply Chain and Materials Management teams to coordinate timely delivery of materials and proactively resolve inventory discrepancies.
• Communicate changes in production needs or material availability to prevent production delays.
• Update detailed manufacturing schedules with input from Process Performance, Maintenance, Validation, Engineering, and other functional teams.
• Perform other responsibilities as assigned.

• High school diploma or equivalent with 10+ years of pharmaceutical manufacturing experience.
• Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, and similar applications.
• Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements within the pharmaceutical industry.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong written and verbal communication skills along with excellent organizational skills.
• Ability to work effectively within a team environment to maximize efficiency and throughput.

• Regular use of hands to handle materials and supplies.
• Ability to use electronic devices for extended periods throughout the workday.
• Ability to communicate effectively by telephone and electronic communication.
• Ability to regularly stand and walk for extended periods.
• Ability to occasionally lift and/or move up to 25 pounds.

This position will help strengthen manufacturing operations by driving continuous improvement initiatives, enhancing operational performance through data-driven decision-making, and ensuring manufacturing teams have the documentation, materials, and processes necessary to safely and efficiently produce life-changing pharmaceutical products. Success in this role will improve operational efficiency, strengthen cross-functional collaboration, and support Kindeva's commitment to quality, compliance, and operational excellence.

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.