Description

Title:

CGT Operations Engineer

Job Purpose:

The main responsibilities for handling LN₂ cryogenic freezer products include reception, storage, and dispatch. Assist in the setup of the new LN2 area in Frankfurt Depot and generate and review of validation documents (URS, DQ, IQ, OQ, PQ).

Main Duties and Responsibilities:

• Train Depot Operations before validation activities to ensure Marken, global and technical standards.
• Train Depot Operations on corrective and preventative actions to ensure continuous improvements.
• Facilitate and perform Risk Assessments as required.
• Training of team members.
• Verification processes of the Depot operations.
• Oversight of the follow-up of the annual maintenance schedule and arrangements of the equipment maintenance with the maintenance providers.
• Performing investigations regarding area non-conformances and implementation of appropriate actions to prevent a recurrence.
• Participation in the improvement processes for the Depot operations, SOPs, and all related to the execution of activities in the depot.
• Implementation of area KPIs and continuous improvement initiatives.
• Take over responsibilities in creating and writing SOP´s Training material.
• Ensure performance maintenance and backup for the Central Monitoring system.
• Ensure compliance with the requirements of GMPs.
• Support client audits and regulatory audits.
• Generation of shipping documentation upon receipt of project requests including verification steps.
• Preparation of shipment export documentation including verification steps.
• Inspection of supplies picked for shipment by other associates.
• Create inventory pick lists within Depot Inventory Management System.
• Post shipment notification to clients.
• Stock control including periodic cycle counts.
• Perform CMS sensor challenges.
• Administration duties assigned by line manager.
• Perform CMS daily checks during weekends with on-call mobile.

Requirements:

• At least 5 years of experience directly related to the duties and responsibilities specified.
• Bachelor's degree in Microbiology, Biochemistry, or Genetics.
• Knowledge of current and emerging issues and trends in the area.
• Knowledge and understanding of biosafety principles, policies, and procedures.
• Extensive knowledge and understanding of regulations.
• Ability to use independent judgment and to manage and impart confidential information.
• Skill in examining and re-engineering operations and procedures, and formulating policy.
• Ability to develop and present educational programs and/or workshops.
• Program development and management skills.
• Investigative and problem solving skills.
• Good command of English.

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.

Moving Our World Forward by Delivering What Matters.