Manufacturing Process Engineer

Key Responsibilities

• Designs and project manages changes, improvements, new systems and or equipment.

• Prepares Change Control Records (CCRs), Design Specifications, User Requirements Specifications, System Specifications, Design documents, Drawings, and Validation Documents for improvement, planned and corrective maintenance and system or process improvements

• Leads/assists in Continuous Improvement Projects, including identification of opportunities, researches literature and vendors, prepares and presents proposals, develops and executes projects, and closes projects, all following appropriate change control methodologies

• Represents Technical Subject Matter Expert (SME) in teams assembled to specify, install, troubleshoot and maintain systems, equipment and processes

• Supports day-to-day production and maintenance activities

• Provides training support as required.

• Develops and or modifies SOPs for the Processes and Equipment.

• Participates in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA).

• Creates and maintains drawings and sketches.

• Manages Technical Publications Library to ensure the relevant manuals, specifications, design information for all of our facilities, utilities, equipment and products are on hand

• Primary/First Line responsibility for operation and maintenance of the Validated Systems to maintain production capability required.

• Primary/First Line responsibility for enhancements and upgrades of manufacturing related systems to maintain production capability.