Senior/Lead Validation Engineer
QLS are recruiting for a Senior/Lead Validation Engineer to join a Global Biopharmaceutical Company based in Bern on a contract basis for 8-9 months initially but likely to be extended until 29.02.2024
Key Responsibilities:
- Define strategy,plan, coordinate and execute the core business phases of Lifecycle Process validation activities based on specific assigned role and responsibilities
- Ensure the validation activities are properly planned and executed as per Lifecycle Process validation process
- Ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans
- Authoring, review and approve validation plans, protocols, reports
- Perform risk/criticalityassessments, technical and GMP related documentation
- Bridging with multi-functional teams handling and ensuring facilities, equipment and process readiness for GMP production
- Proven experience with process validation related activities suchas (but not limited to): cleaning validation of product contact equipment, process performance qualification (PPQ), continued process validation (CPV), media fill (APS), sterility assurance relevant supporting validation activities such as (but not limited
Qualifications:
- MSc degree (or BSc with increased level of experience: 7-9 years) in technical or life sciences
- A minimum of 6 years of working experience within pharma company in validation or equivalent position
- Experienceworking in different project teams at the same time
- Experience in project management
- Fluency in English
- Fluency in German is a plus
- Excellent interpersonal skills
- Proficiency in Word, Excel, PowerPoint, Visio & MS Project
- Analytical thinking, teamwork, and problem-solving ability
- Able to manage multiple priorities simultaneously
- Ability to work with limited supervision
Apply:
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 job reference 55480 in all correspondence.
