Qualification & Validation Engineer (m/w/d)
View: 153
Update day: 29-03-2024
Location: Basel Basel-Stadt BS
Category: Pharmaceutical / Chemical / Biotech
Industry:
Job type: Temps plein, Durée indeterminée
Job content
Let me introduce you shortly Tech’Firm :
Tech’Firm is a Swiss engineering company with more than 20 years of experience and 300 dedicated engineers.
Our motto: Delivering with happiness!
We offer a friendly environment with trustworthy relationships. Our mission is to give meaning to the activities of everyone in the company.
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WE ARE LOOKING FOR Q&V ENGINEERS (m/w/d)
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Key responsibilities:
- Owns all quality related responsibilities for the commissioning and qualification
- GMP manufacturing of biologics & APIs.
- Representative of Quality in the CAPEX project organization in regards to qualification of facilities, utilities, equipment and systems (incl. computerized systems).
- Reviews and releases of qualification documents and SOPs.
- Be a Subject Matter Expert (SME) and provides guidance and recommendations to (C&Q)) activities of dedicated new facilities, equipment and utilities related to the internal or external customers
Key requirements:
- Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
- Strong background in cGMP
- Broad knowledge in qualification of equipment, facilities, utilities (biopharmaceuticals & APIs) and related Guidelines (e.g. ASTM, ISPE, GAMP)
- Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Excellent verbal, written and interpersonal communications skills o Fluency in English, German would be an advantage
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We are looking forward hearing from you !
Kind regards,
Your Techfirm Team
Job Types: Full-time, Permanent
Schedule:
- Monday to Friday
Work Remotely:
- No
Deadline: 13-05-2024
Click to apply for free candidate
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