Senior Validation Engineer
QLS are recruiting for a Senior Validation Engineer to join a Global Biopharmaceutical company based in Bern on a contract basis until the end of the year.
In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late Stage Development department. The Sr. Validation Engineer is primary responsible that validation studies are carried out conform to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
Job Responsibilities:
- Defining strategy, planning, coordinating and executing all phases for supporting validation activities such as (but not limited to) sterilization in place, autoclave load validation,washing machine cleaning validation, buffer hold time. Define strategy, plan, execute and coordinate sterility assurance relevant supporting validation activities such as (but not limited to) smoke studies in operations, CCIT, sterile hold time, vessel integrity and filter validation.
- Defining strategy, planning, executing and coordinating cleanrooms performance qualification and process equipment performance qualification.
- Ensuring the validation activities are properly planned and executed as per Lifecycle Process validation process and are reported back in the applicable site Supporting Validation Plans and Validation Master Plans Authoring, review and approve validation plans, protocols, reports
- Performing risk/criticality assessments, technical and GMP related documentation
- Bridging with multi-functional teams handling and ensuring facilities, equipment, and process readiness for GMP production. Works with greater autonomy for longer term activities independently interpreting data, identifying project needs, and proposing solutions
- Collaborating effectively with fellow project members following priorities, checkpoints, and timelines in support of objective
- Supporting engineering, quality, quality control and production in a campus-wide validation team. Coordination and oversight of external validation partners.
Candidate's Requirements:
- MSc degree (or BSc with increased level of experience: 5-7 years) in technical or life sciences
- A minimum of 3-5 years of working experience within pharma company in validation or equivalent position
- Experience working in project teams
- Experience in project management is a plus
- Profound know-how of Validation requirements according to cGMP regulations
- Basic Know-how of biotechnology processes
- Analytical thinking and problem-solving ability
- Fluency in German is a plus
Apply:
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56716 in all correspondence.
