Manufacturing Process Technician

Fuldtid

Permanent

ID: 2219387

Indrykket for 154 dage siden

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 Manufacturing Process technician

In your role in the manufacturing area, you will have the opportunity to be involved in technology transfer and process validation projects and participate in the manufacturing of sterile products.

You will be working into the Production department and close to other departments such as, Engineering and qualifications, Regulatory Affairs, CMC R&D, QA, etc.

Fields of responsibility:

Define and document process and equipment requirements based on product requirements, quality requirements and customer needs.

Process transfer from R&D to the manufacturing site: implementation of new products on routine manufacturing.

Participate in the definition and supervise the execution of the process performance qualification.

Support Activities: Filter Validation, Leachables and Extractables, nitrosamines evaluation.

Support on project documentation and coordination.

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...)

Your qualifications

As a candidate for the role you have:

Required Education: Degree on Science or Engineering.

Experience in pharmaceutical manufacturing. Knowledgeable of the related normative (GMP and/or FDA)

Experience of at least three years in similar position: Process Validation or aseptic production supervisor.

Advanced level of English spoken, written and understood, French is a plus

Knowledgeable in Quality Systems and Validation standards, policies, procedures and methodologies.

ALK is located in the business area of Ciudad Lineal, close to the centre of Madrid. We have quick access to the Hermanos Garcia Noblejas and Ascao metro stations and we also have a wide bus connection. The manufacturing site is located at Calle Miguel Fleta 19 while the Business Support area is in an adjoining building located at the Avalon Business Park.

ALK, among other benefits, has a canteen where the employees can have breakfast and lunch every day and offers days of teleworking as part of its social benefits.

Husk at skrive i din ansøgning, at du så jobbet hos Ofir