Sr. Process Improvement Specialist

A brief overview

The Sr. Process Improvement Specialist is responsible for the collection, statistical analysis and visualization of production data to support the manufacturing team in increasing process performance, robustness and efficiency. The Specialist will identify and apply appropriate analytical techniques to gather data, identify areas of improvement and recommend necessary process controls or other actions to increase process efficiency. The specialist will be an individual contributor while reporting to the production department and coordinating with other involved functional areas as well as other sites if necessary. The Specialist may work as the key user of SAP for Production and Production related activities. The Specialist will have a significant impact on manufacturing strategies and in the assessment of the product portfolio.

What you will do

• Analyzing selected manufacturing processes, identifying and applying appropriate analytical techniques to gather data, identify areas of improvement, and recommending necessary process controls or other actions to increase process efficiency
• Generate Key Performance Indicators to provide a focus for strategic and operational improvements Report to department leadership on process performance of ongoing manufacturing projects.
• Lead efforts to develop standard data acquisition processes that can be applied to all projects, managing multiple time sensitive projects to deliver targeted outcomes, involvement in planning long-term or short-term business objectives and organizing departmental efforts to identify, prioritize, and assessing the impact of process parameters of ongoing manufacturing and training other team members to perform data analysis
• Organizing departmental efforts to identify, prioritize and assess the impact of process parameters of ongoing manufacturing, identifying causes of variability in multi-stage production processes utilizing process maps to illustrate manufacturing processes flow and defining quality metrics to illustrate the impact of process improvement to customers
• Define quality metrics to illustrate the impact of process improvement to customers, utilizing trend analysis to identify opportunities for improvement in manufacturing processes. Manage and monitor Continuous Process Verification programs. Present findings to stakeholders using PowerPoint, graphs, charts, etc.
• Draft and review MBPRs, SOPs, deviations, investigations, and other technical documents, tracking CAPAs related to the manufacturing department to ensure that commitments are met within established timelines
• Ensure compliance with the Bachem Quality Management system and with cGMP guidelines.
• Assist managers schedule, enter data using planning systems and coordinate production activities.

Qualifications

• Bachelor's degree in life sciences, computer information systems or related field
• 4+ years of experience with reporting tools such as Hyperion/Brio or other statistical software systems
• 4+ years of process improvement or operations experience
• SAP experience (preferred)
• Previous manufacturing experience, preferably in the pharmaceutical industry
• Experience working in a cGMP environment (preferred)
• Experience with statistical analysis applied to pharmaceutical manufacturing (preferred)
• Knowledge of SAP transactions and troubleshooting
• Excellent verbal, written communication and presentation skills.
• Excellent organizational skills
• Detail oriented with the ability to troubleshoot and resolve technical and analytical problems.
• Strong understanding of interdependencies with cross-functional stakeholders and business implications of decisions
• Positive and determined attitude with the ability to communicate in a proactive and solution-focused manner; keep management informed of potential issues
• Ability to work independently and manage one’s time
• Exposure to statistical reporting tools including Minitab, Adonis and Power BI