Project and Qualification Engineer

ALK-Abelló A/S

Fuldtidsjob
Udlandet (øvrige)

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.
Contact
For further information on the position, please contact LGJES@alk.net


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Fuldtidsjob
Udlandet (øvrige)
Maskin & Design
Produktion, Logistik & Transport
Teknik & Teknologi
Data & analyse
Produktion
Teknik



ALK-Abello - hurtigt overblik


ALK-Abello
ALK-Abello
ALK er en global forskningsbaseret medicinalvirksomhed med fokus på allergi og allergivaccination

Placering
Bøge Alle 6
2970 Hørsholm
Logo: ALK-Abello
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