Senior Analyst, Manufacturing Process

Role Summary

Senior Analyst, Manufacturing Process. Responsible for the management of production projects that improve manufacturing efficiency and safety, decrease costs, reduce opportunities for human error, or increase compliance. Works with peers in other departments to meet project timelines. Responsible for tracking the transfer, implementation and monitoring of projects. Uses systems and databases to input, verify, monitor and analyze data. Identifies opportunities for improvement of manufacturing and business processes. Proposes, plans and facilitates implementation of improvement solutions. Responsible for inventory maintenance and production tracking.

Responsibilities

• Applies knowledge and technical skills to understand Production objectives, support Production initiatives, execute systems and procedures efficiently and compliantly, and evaluate systems for improvement potential. Maintain GMP compliance and standard practices for inter-group consistency.
• Schedules work tasks to support project timelines. Circulates documents to reviewers, responds to comments, and manages document review and approval to meet timelines.
• Uses judgement within defined procedures to determine action. Tracks problems, analyzes data, develops solutions, and presents implementation plans to management.
• Assists in validation activities for manufacturing equipment and provides technical assistance and troubleshooting.
• Establishes requirements and assists in implementing changes to the Process Control System.
• Investigates production events with quality or compliance impact. Leads or participates in RCPS or FMEA sessions. Documents outcomes.
• Transfers methods into Production instructions and provides training to ensure successful rollout of new methods.
• Manages inventory and production tracking. Subject matter expert in SAP for inventory and production. Tracks bulk usage, supports inventory management, and interfaces with Planning to manage process order and batch numbers. Initiates and tracks blanket purchase orders. Tracks yield performance and reports to supervision and Finance.
• Interacts with functional peer groups and presents technical information about projects and schedules.
• Complies with company policies, engineering standards, plant procedures, and regulatory requirements.

Qualifications

• Bachelor‚Äôs Degree or equivalent, preferably in engineering or related field.
• At least 5 years of experience in manufacturing/production processes with strong writing skills.
• Knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps; familiarity with regulatory filings; proficiency with tech transfer and equipment/facilities validation.
• Ability to handle multiple tasks under pressure; works well in a team; maintains professionalism and builds effective working relationships.
• Intermediate to high computer and MS Office skills.

Skills

• Process improvement
• Project management
• Data analysis and problem-solving
• Technical writing and documentation
• SAP inventory and production knowledge
• Validation and equipment troubleshooting

Education

• Bachelor‚Äôs Degree or equivalent in engineering or related field