Manufacturing Process Validation Specialist
The site in Visp, Switzerland is growing and for our Bioconjugates organization, we are currently looking for a Manufacturing Process Validation Specialist. In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale and Product Quality Reviews (PQRs).
* Main Responsibilities:
o Prepare validation documents (study design / writing protocols and reports) according to procedure and in compliance with regulatory guidance.
o Own the process validation including communication with customers.
o Review and approve of process characterization documents.
o Responsible for the validation assessment on changes and deviations (approval of deviation and changes).
o Prepare and maintain a documented continued process verification plan.
o Author, assess, and approve of PQRs.
Key Requirements
* Education: Master or Ph.D in Chemistry, Biotechnology, Life Sciences or related field, or equivalent experience.
* Experience: Experience in project management, preferably in MSAT, Operation, Quality and Compliance.
* Skill Set: Ability to work on different tasks simultaneously and in a timely manner.
* Interaction Skills: Experience in interaction with different teams within an organization and with regulatory agencies would be an advantage.
About the Role
This is an exciting opportunity to join a dynamic team and contribute to the growth of our Bioconjugates organization. If you have a strong background in process validation and quality assurance, and enjoy working in a fast-paced environment, we encourage you to apply.
We are committed to providing our employees with opportunities for growth and development, as well as a comprehensive benefits package. Our goal is to attract and retain top talent who share our values and are passionate about making a difference in the life sciences industry.
If you are interested in this opportunity, please submit your application, along with your resume and a cover letter explaining why you are a strong fit for this role.