ALK-Abelló A/S Spain

Project and Qualification Engineer


The position

The successful candidate will work in charge of different projects and qualifications related to production, utilities and facilities areas

He/She will be accountable of performing the assigned projects on time and cost, establishing the general automation requirements for the manufacturing, QA and QC equipment and ensuring the fulfilment of such requirements either with internal or external crew.

Fields of responsibility

·Lead the project & collaborate with all stakeholders in the scoping, design, sourcing, installing, commissioning, qualification & handover of equipment for the production areas.
·Define equipment requirements and specifications based on process requirements, safety requirements, quality requirements and customer needs.
·Evaluate or assist in evaluating technology necessary to support requirements.
·Assist in determining the budget to support requirements.
·Manage the efforts of the subcontractors and vendors to ensure that the correct job priorities and schedule are met.

·Define qualification strategy (Valdiation Plan) and execute the qualification of the equipment/GMP utilities and facilities (IQ,OQ,PQ)

· 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

·Degree on Science or Engineering
·Demonstrated capability of working with GMPs.
·Advanced level of English spoken, written and understood.
·Experience of at least three years in similar position.

·Experience on basic software handling (changes, back-ups, restoration, etc.).
·Knowledgeable in the understanding and execution of GAMP5 and CSV.
·Knowledgeable in Quality Systems and Validation standards, policies, procedures and methodologies

We offer

ALK provides a   uniquely dynamic and pleasant work environment, complete with inspiring and   challenging assignments. The results of your efforts will be significant   throughout the organization and you will be able to actively influence and   challenge the status quo. Our flat structures attract independent individuals   who like to feel the progress of the business and enjoy being close to the   decision-making process. You will be part of an engaged and informal global team   who values skill and knowledge creation. The job is very flexible and you   have very much influence on your daily work.The new position is being a part   of a global team, with team members in Spain and Denmark, the position will   be located in the Madrid office.

Please apply in English.


For further information on the position, please   contact


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Comunidad Autónoma:
Comunidad de Madrid
Plazo de solicitud:
Teléfono: +34 913276100
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