Beschreibung
Process Expert (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Provide front line expertise for all process-specific issues to production within one or more production steps and equipment, to ensure execution of processes on-time
- Continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs, SHE and applicable guidelines
- Manufacturing Processes: Own and provide expertise to the assigned manufacturing process and support the goal of executing each batch safely, in time, in compliance with the quality requirements
- Technical Transfers and Validation: Execute and support technical transfer and (re-)validation projects incl. all relevant documentation and implement and support scale-up activities of existing processes
- Technical improvements: Execute and support process improvement projects // Drive and support implementation of new technologies/equipment
- Investigations: Lead process related trouble shootings/investigations and deviation investigations // Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures
- Audit support: Maintain the assigned processes/equipment at Inspection readiness level and provide the necessary support in any internal or external audit
- Batch record: Perform review of batch records
Main qualifications
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree / equivalent experience. Desirable MSc. or equivalent experience
- Profound experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
- Proven process understanding with profound understanding of regulatory and cGMP requirements
- Lean Green Belt certification (preferred but not required)
- Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
- Familiarity with GMP requirements, quality procedures and SOP execution
- Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor
- Strong team orientation
- Structured and proactive working attitude
- Self-driven and result-oriented
- Proven IT knowledge, knowledge in SAP or MES is an asset
Main advantages:
- Continuous support during the assignment
- Dynamic and innovative market environment
- Modern, perfectly equipped workplace
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Marc-Sebastian Heftrich
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