Senior Lab Equipment Qualification Lead

Anacura Group; Oost-Vlaanderen; À distance; EUR 65 000 - 90 000; Plein temps

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Anacura, a family-owned, growing center of excellence in healthcare with over 300 employees consists of 4 independent business units: Labo Nuytinck, active in medical analytics and Anabiotec, OHMX.bio and Discovery Studio, active in drug development. The labs have their main activities in a state-of-art building in a green surrounding near Ghent, Belgium.

Anabiotec provides analytical services for characterization, assay development and quality assessment of novel and established medicines, ranging from synthetic molecules and biologics, to cell & gene therapies. With more than 25 years of experience we contribute to these medicines of tomorrow by helping our customers to accelerate their drug development journey. We support startups, biotech as well as large pharma companies worldwide from pre-clinical drug development, through clinical phases I, II, III all the way to commercialised treatments. We take proud in our flexibility, diligence and science thereby operating as an extension of our clients with tailored solutions and pro-active, science driven advice. To achieve all this, Anabiotec is set-up as a workspace with open doors where all our employees are encouraged to continuously improve & grow and are welcomed to actively contribute to the goals of Anabiotec.

Role

• As a Subject Matter Expert (SME), you will delve into complex matters relating to equipment, maintenance and qualification. You will also act as the point of contact for this, both within the Engineering & Maintenance department and across the organisation.
• You will carry out and/or oversee (complex) preventive maintenance, calibrations, validations, troubleshooting and documentation, where necessary in collaboration with the supplier, in accordance with the applicable quality guidelines.
• In the event of unexpected equipment problems, you will carry out diagnostics, where necessary with the assistance of the supplier, and subsequently carry out and/or supervise the necessary repairs and calibration tests prior to release. You will also draw up and carry out the associated out-of-calibration or deviation investigations.
• You will be responsible for drafting validation protocols, and for carrying out and documenting the validation of new equipment/software based on all technical documentation, legislation, standards and GXP guidelines. You will also draft validation reports for laboratory equipment and application software.
• You will draw up and revise maintenance instructions. You will also provide input for the drafting of operating instructions for the equipment in use, and evaluate and implement USP/Ph. Eur. revisions and new chapters.
• You will (re)evaluate and prepare maintenance contracts with suppliers.
• For the Engineering & Maintenance department, you will also draw up the operational schedule, including the scheduling of external maintenance, calibrations and interventions, whilst taking into account the strategic planning for the implementation of new equipment.
• You will identify bottlenecks, critical issues or opportunities for improvement relating to equipment, software or the department’s operations, whilst contributing to or leading improvement projects.
• You will work at least 80 per cent of full-time hours and report to the Engineering & Maintenance Manager.

Your Profile

• You hold a degree in a scientific discipline and have around 5 years’ relevant experience in laboratory equipment maintenance and qualification, preferably in a GXP environment.
• You enjoy resolving unexpected situations, combining strong analytical skills with a pragmatic and solution-oriented approach.
• You are a skilled multitasker, cope well with changing schedules and priorities, and possess strong organisational skills.
• You enjoy working in a team, inspiring and coaching your colleagues, and seeing your projects through to a successful conclusion.
• Knowledge of software validation/qualification (GAMP5) and an affinity for project management are an advantage.
• You have an excellent command of Dutch and English.

Our Offer

• You will be part of the Anacura group, a family owned, long term focused and ambitious laboratory organization.
• You will join a dynamic team and have a position with autonomy and responsibility with opportunities to take initiatives to support further growth.
• You will be offered a competitive salary with fringe benefits, a green work environment and the possibility to join our bike lease program, flexible working hours, a healthy lunch and a pleasant fun club.
• You are stimulated in your personal growth; we build on your talents in accordance with our ambitions.

Interested?

Your application will be considered quickly and with the greatest confidentiality. For additional information please contact Britt Van de Velde: [e-mail] or [phone].