Beschreibung
Senior Manufacturing Specialist/ Process Expert II MTOOur client, a global BioTech company based in Solothurn, Switzerland is currently seeking for a Senior Manufacturing Specialist with extensive experience in manufacturing and technical processes.
Duration: Initial duration until
Location: Solothurn (Switzerland)
Workload: 100%
Tasks:
- You are responsible for the technical and scientific support to the manufacturing (MFG) shopfloor and will manage timely completion of the MFG activities (Compliance, TT, campaign preparation, troubleshooting etc.)
- Coaching of MAs regarding main area of expertise and side processes
- You are responsible for overseeing and managing intra, cross-site, and cross-functional projects related to process and productivity improvements
- Manage recipe-driven operations, process equipment, deviation management, changeover, tech transfer, projects (change control and CI) and direct process support as applicable
- Identify, troubleshoot, and resolve moderately complex technical and operational problems that arise
- Create projects as needed to establish new manufacturing techniques to resolve day-to-day issues with management guidance
- Proactively identify improvement opportunities, share knowledge cross-functionally, and drive site and / or global implementation
- Act as Subject Matter Expert on Manufacturing equipment and processes
- Collaborate with direct manager to assign appropriate resources to tech transfers, drive continuous improvement, and ensure the manufacturing instructions are clear, safe and compliant
- Initiate, own, and manage Manufacturing-focused Change controls, CAPAs and Planned Exceptions
- Perform root cause analyses in DEV/AA/RAR reports in TrackWise
Requirements:
- Strong manufacturing / technical process knowledge and / or strong knowledge of scientific principles as well as analytical skills to troubleshoot process issues and perform investigations
- Relevant Bachelor´s degree or higher preferred
- 6-8 years' experience working in a GMP environment
- Experience working in a cross-functional team
- Past experience in coaching and training a team on manufacturing-related activities
- High knowledge of Manufacturing Systems (DeltaV, Syncade, SIMCA, PI, Oracle, TrackWise etc.)
- Very good understanding of Quality Assurance and cGMP principles
- Very good level of technical writing skills
- Proficient in Microsoft Office
- Excellent communication and documentation skills
- Fluent in English (verbally and orally)
- EU passport or Swiss work permit
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV including your hourly rate expectation for immediate consideration.
You can reach me on or at f.miranda"at"realstaffing.com
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.