Pilot Plant TSMS Engineer

Job Description

Job Description

The Pilot Plant TSMS Engineer will support equipment-related projects within the Fermentation Pilot Plant. This role provides technical expertise, operational support, and process improvement initiatives to ensure safe, efficient, and compliant operations in accordance with cGMP standards and internal procedures.

Key Responsibilities

• Apply scientific and engineering principles to fermentation manufacturing processes.
• Translate process requirements from operational instructions, procedures, and process flow documents into field execution.
• Review, prepare, revise, and approve production and operational instructions as a co-owner.
• Provide technical support for troubleshooting and implementation of corrective and preventive actions.
• Perform fermentation process tasks such as tank discharge, material handling, raw material charges, equipment cleaning, and in-process testing.
• Support daily operations management, including providing technical support for 24 / 7 activities as needed.
• Participate in Process Team meetings and weekly huddles.
• Understand operational control strategies and how equipment impacts key process parameters.
• Lead or support technical documentation and execution related to equipment events, CAPAs, and changes.
• Provide expertise in the installation, operation, maintenance, and reliability of pilot plant equipment.
• Contribute to Process Validation efforts, including assessment of changes, maintenance interventions, preventive maintenance (PM) plans, and spare parts management.
• Assist with the preparation and execution of verification and qualification documents.
• Ensure compliance with all applicable policies, regulations, and safety requirements (e.g., LOTO, line breaking procedures).
• Make informed decisions within established guidelines to maintain quality and safety standards.

Requirements

Benefits