Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Preparation of Solutions and Media

Proactively implement all steps related to solution preparation, in alignment with established schedules.

Perform the following tasks: weighing, dissolving, pH measurement and adjustment, sterile filtration or autoclaving, aliquoting, labeling, and packaging.

Carry out depyrogenation and sterilization of production equipment.

Conduct routine microbiological and particulate monitoring of production areas.

Prepare consumables and solutions required for upcoming production steps.

Request and produce appropriate labels.

Coordinate the request and receipt of Collect & Go containers, and prepare pallets when necessary.

Operational Support

Participate in the theoretical and practical training of new team members.

Attend meetings essential to the role.

Apply the 5S methodology to maintain a clean and organized work environment.

Comply with and enforce current safety and biosafety regulations.

Ensure adherence to SOPs and GMP standards.

Provide regular updates on project progress as required.

Clean non-aseptic cleanrooms.

Take part in Line Clearance activities at the start, during, and end of campaigns.

Organizational Tasks

Independently manage day-to-day field logistics for production activities.

Handle temporary stock management (active components, consumables, raw materials) related to the project.

Oversee project-specific equipment setups.

Facilitate coordination with other platforms.

Ensure efficient management of local inventory.

Documentation Tasks

Ensure accurate data entry into management systems (e.g., SAP).

Maintain traceability of all operations through real-time completion of checklists and production documents, in accordance with good documentation practices.

Contribute to quality system management: review and draft SOPs and equipment setup sheets, implement CAPAs, manage deviations (in close collaboration with team and project leaders), complete logbooks and checklists, and review and compile batch records.