Sr. Process Improvement Specialist
About The Position
The Sr. Process Improvement Specialist collects, statistically analyzes, and visualizes production data to help the manufacturing team increase process performance, robustness, and efficiency. The role identifies and applies analytical techniques to gather data, find improvement opportunities, and recommend process controls or other actions to improve efficiency. This individual contributor reports to the production department and coordinates with other functional areas and, when necessary, other sites. The Specialist may serve as a key user of SAP for Production and related activities and can significantly influence manufacturing strategies and product portfolio assessments. The position also supports production planning and activities, manages process-performance and continuous-verification work, and prepares and reviews manufacturing and quality documentation. It ensures work aligns with Bachem’s Quality Management System and cGMP guidelines.
Requirements
- Bachelor’s degree in life sciences, computer information systems, or a related field.
- At least 4 years of experience with reporting tools such as Hyperion/Brio or other statistical software systems.
- At least 4 years of process improvement or operations experience.
- 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 cross-functional stakeholder interdependencies and the business implications of decisions.
- Positive, determined, proactive, and solution-focused approach, including keeping 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.
Nice To Haves
- SAP experience.
- Previous manufacturing experience, preferably in the pharmaceutical industry.
- Experience working in a cGMP environment.
- Experience with statistical analysis applied to pharmaceutical manufacturing.
Responsibilities
- Analyze selected manufacturing processes; apply appropriate analytical techniques to gather data, identify improvement areas, and recommend process controls or other actions to increase efficiency.
- Generate key performance indicators and report ongoing manufacturing project performance to department leadership.
- Develop standard data-acquisition processes applicable across projects and manage multiple time-sensitive projects to targeted outcomes.
- Participate in short- and long-term business planning and organize departmental efforts to identify, prioritize, and assess the impact of process parameters in ongoing manufacturing.
- Train other team members to perform data analysis.
- Identify causes of variability in multi-stage production processes and use process maps to illustrate manufacturing process flows.
- Define quality metrics to demonstrate the impact of process improvements to customers and use trend analysis to identify improvement opportunities.
- Manage and monitor Continuous Process Verification programs.
- Present findings to stakeholders using PowerPoint, graphs, charts, and similar materials.
- Draft and review MBPRs, SOPs, deviations, investigations, and other technical documents.
- Track manufacturing-department CAPAs to ensure commitments are met within established timelines.
- Ensure compliance with the Bachem Quality Management System and cGMP guidelines.
- Assist managers with scheduling, entering data into planning systems, and coordinating production activities.
Benefits
- Competitive pay.
- Annual performance bonus.
- Comprehensive medical, dental, and vision coverage.
- 401(k) plan with employer contribution.
- Paid vacation, personal, and sick days.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
