Are you an expert on sterile production and process design and validation?
World leader in allergy
ALK's aspiration is to become the world leader in allergy by helping as many people with allergy to a better life by providing options of prevention, diagnosis, and treatment of allergy.
Your role as Process Technician
In your role in the Validation and Process Improvement area, you will have the opportunity to design new manufacturing process for sterile products, be part of process validation and participate in the manufacturing site projects related with sterile and no sterile production.
You will be working into the Production department and close to the other departments such as, regulatory affairs, CMC R&D department, QA, etc … for new process registration or variation.
The successful candidate will work in different projects and qualifications related to production for current or new products.
You will be in a department for:
Define process requirements and specifications based on product requirements, quality requirements and customer needs.
Legacy products Process Validation, process parameter review and definition, Process control Strategies
Process transfer from R&D to the manufacturing site, development batches: manage of process materials and requirements.
Support Activities: Filter Validation, Leachables and Extractables, Single use design…
Project Documentation: development and transfer documentation, timelines, validation plan, protocol and report, etc…
Take accountability of the quality and compliance aspects of the referred activities performing the required actions (risk analysis, documentation, inspections participation, observations responses, SOP'S, etc...)
As a candidate for the role you have:
Required Education: Degree on Science or Engineering
Process Validation Experiences, 2-3 years.
Sterile Manufacturing knowledge accountable
Advanced level of English spoken, written, and understood.
Contact and application
If you need further information about the position, please contact HR area, Leticia Garcia on email@example.com
We look forward to hearing from you.