Process Engineer
QLS are recruiting for a Process Engineer to join an important project with a Global Biopharmaceutical Company at their site based near Lucerne on a contract basis for one year with option of an extension.
Main responsibilities:
- Participate inTechnology Transfers from Development
- Author, Review and Approve Master Batch Sheets
- Review executed Batch Sheets
- Author, Review and Approve SOPs
- Coordinate all the preliminary activities for batch filling (material management, BatchSheet, machine recipe)
- Manufacturing on the Shopfloor in coordination with other members of the team (Setup, Filling)
- Coordination of visual inspection qualification program
- Participating in Process Simulation strategy and coordination of Shopfloor activities during Process Simulation/clinical batches
- Participating in product- and equipment- related deviations.
- Keep contact with supplier for complaints, improvements, service requests
- Design, Qualification, Validation andMaintenance of Equipment
- Inventory, Spare Parts, Manufacturing Capacity Planning
- Investigate and Purchase new technologies to bring efficiencies to the organization and make the area a leader of innovation within the global network.
- Worktogether with Validation and Quality Group on GMP documents such as Batch Sheets, Campaign Summaries, Validation Protocols, NOEs, Changes, Process Simulation Reports Minimal work direction needed, highly skilled and knowledgeable to the position.Candidate’s Requirements:
- Experience in GMP production
- Experience with changes/deviations/CAPA/operating procedure
- At least 1 year of work experience in the pharmaceutical or biotech industry
- Familiarity with Biotech GMP Manufacturingprocesses and working within an Aseptic Environment
- Good communication skills in English and German required
Entitlement to work in Switzerland is essential. For more information or to apply for this position, please contact Adrien on 0041 (0)800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference 52294 in all correspondence.
