Qualification Engineer (m/f/d)

Beschreibung

Qualification Engineer

location: Switzerland

start date: ASAP

Activities:

• Prepare CQ lifecycle documents acc. to the company standards
• Be the single point of contact and coordinate document reviews and approvals for one process step (Media Preparation, USP, REC or DSP)
• Based on progress report of the CQ manager, perform on a regular basis field spot check follow-up
• Communicate the day to day schedule to the technical lead, CQ manager and Operation leads.
• Ensure a good communication with other Specialists linked to its activity (Battery limits)
• Maintain his knowledge accuracy based on new technology. Keep up-to-date, report, escalate if necessary.

About your competencies and experience:

• 3+ year-experience in large scale EPCM (Engineering, Procurement and Construction Management) in the pharmaceutical industry
• Strong background within manufacturing process equipment (USP, REC, DSP, MP) and its functionalities.
• Comos knowledge preferable.
• Knowledge of electronic documents management system (Documentum D2) is a must.
• In-depth technical experience in a regulated environment with knowledge of biologicals, pharmaceutical and engineering operations
• Good understanding of EHS (Environment, Health and Safety) and Quality aspects
• Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
• Bachelor, Master diploma or equivalent in biotechnology engineering
• Profound knowledge of USP/ DSP/ small and lab equipment technologies
• English spoken and written mandatory
• Fluent German is advantageous
• Willingness to work in an international environment

Interested?

If you would like to apply for this pharmaceutical project as Qualification Engineer (m/f/d), please contact me via phone for more information. Or you can apply directly by clicking the Apply button.

We are looking forward to your application.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.