Senior Continuous Improvement Specialist II

Kindeva Drug Delivery

$85K — $110K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • High school diploma or equivalent with 10+ years of pharmaceutical manufacturing experience.
  • Proficiency in Lean tools and software like Smartsheet, Power BI, and Power Apps.
  • Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
  • Ability to make decisions on compliance-related issues with moderate supervision.
  • Strong organizational and communication skills.
  • Capacity to manage multiple tasks in a dynamic work environment.

Responsibilities

  • Lead continuous improvement projects to optimize manufacturing processes and reduce costs.
  • Identify and implement improvements in process performance and inventory management.
  • Facilitate Kaizen events and training sessions to foster a culture of excellence.
  • Collaborate on implementing Lean manufacturing tools and techniques.
  • Ensure timely availability of production documentation and perform compliance reviews.
  • Coordinate with Supply Chain to resolve inventory discrepancies and avoid production delays.
  • Update manufacturing schedules based on input from cross-functional teams.

Benefits

  • Opportunities for professional development and training.
  • Collaborative work environment with cross-functional teams.
  • Engagement in meaningful work that impacts patient health.
  • Support for a culture of continuous improvement.
  • Flexibility in work hours to adapt to production needs.
Full Job Description
The Impact You Will Make

As the Senior Specialist, Operational Excellence & Data Analytics, you will play a critical role in driving operational excellence and continuous improvement across our manufacturing organization. You'll serve as a key liaison between Manufacturing, Quality Assurance, Supply Chain, and Materials Management to ensure production teams have the resources, documentation, and data needed to operate efficiently while maintaining compliance.

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.

Responsibilities

Continuous Improvement & Operational Excellence
  • 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.

Production Documentation & Paperwork
  • 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.

Cross-Functional Collaboration
  • 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.

Qualifications

Required
  • 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.

Physical Requirements
  • 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.

The Impact of the Role

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.

#LI-Onsite #WH

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