Cell and Gene Operations Engineer

☞ Marken

View: 157

Update day: 22-10-2024

Location: Kelsterbach Hesse

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Transportation Logistics Supply Chain Storage

Position: Entry level

Job type: Full-time

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Job content

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5,500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 58 locations worldwide, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2100 staff members manage 120,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

Main Duties And Responsibilities
  • Handling with LN₂ cryogenic freezer products including reception, storage and dispatch
  • Support in Set up new LN2 area in Frankfurt Depot
  • Generation and review of validation documents (URS, DQ, IQ, OQ, PQ).
  • 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 on the follow up of the annual maintenance schedule and arrangements of the equipment maintenances with the maintenance providers.
  • Performing investigations regarding area non-conformances and implementation of appropriate actions to prevent recurrence.
  • Participation on 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 of SOP´s Training material.
  • Ensure performance maintenance and back up for Central Monitoring system.
  • Ensure the compliance with the requirements of GMPs.
  • Support client audits and regulation 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.

General
  • To adhere to all company Policies at all times.
  • To undertake any other reasonable duties at the request of the Line Manager.

Qualifications & Skills
  • At least 5 years of experience directly related to the duties and responsibilities specified.
  • Bachelor’s degree in Microbiology, Biochemistry, 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 regulations.
  • Ability to use independent judgment and to manage and impart confidential information.
  • Skill in examining and re-engineering operations and procedures, 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.

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Deadline: 06-12-2024

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