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 – Validation and Process
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 charge of different projects and qualifications related to production for current or new products.
Fields of responsibility
- Define process requirements and specifications based on product requirements, quality requirements and customer needs.
- Process transfer from R&D to the manufacturing site, development batches: new product implementation support on the manufacturing site for sterile production
- Define qualification strategy and execute the Process Validation related to:
- o Manufacturing PPQ: Compounding, Sterile filtration, filling, inspection, packaging.
- o Cleaning validation
- o Aseptic Process Simulation (APS, Media Fill)
- Support Activities: Filter Validation, Leachables and Extractables, Single use design…
- Technical Support for the CMOs process (Sterile cartridges, tablets, medical device...)
- Project Documentation: development and transfer documentation, timelines, validation plan, protocol and report, etc…
- Process improvement and process standardization
- 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:
- Experience in pharmaceutical manufacturing and/or validation; Knowledgeable of the related normative (GMP and/or FDA)
- Required Education: Degree on Science or Engineering
- Knowledgeable in the understanding and execution of process validation
- Advanced level of English spoken, written and understood, French is a plus
- Experience of at least one year in similar position: Process Validation, Cleaning Validation and/or APS – media fill
- Demonstrated capability of working with GMPs. Knowledgeable in Quality Systems and Validation standards, policies, procedures and methodologies.
Contact and application
If you need further information about the position, please contact HR area, Leticia Garcia on email@example.com
Application deadline: asap
We look forward to hearing from you.