Equipment Engineer Down Stream Processing
Equipment Engineer Down Stream Processing voor een biotechbedrijf in Leiden, Nederland; tijdelijke opdracht met focus op productieapparatuur.
Mogelijk warme-stoelsignaal. Oordeel onzeker; geen bewijs dat al een kandidaat is gekozen.
De combinatie van specifieke downstream-apparatuur (chromatografie, virusfiltratie, UFDF) en GMP-ervaring is typerend voor een niche-biofarmaceutische rol, maar betreft gangbare specialisatie binnen dit vakgebied en geen vereiste van eerdere ervaring bij dit specifieke bedrijf. Er is geen directe aanwijzing voor een warme stoel.
Onderbouwing uit de bron
- Affinity for production equipment (Chromatography systems, Virus Filtration Systems and UFDF and automation systems (e.g. MES, DeltaV))
- Experience with down steam processing equipment and processes
- Knowledge and/or experience with pharmaceutical production process and equipment lifecycle management
Bekijk bij SIRE Life Sciences B.V. (opent in een nieuw tabblad)
Eisen
- A good balance of theoretical and practical insights
- Knowledge and/or experience with pharmaceutical production process and equipment lifecycle management
- A proactive approach with adaptable problem-solving skills, consistently assuming responsibility and taking a leadership role
- Affinity for production equipment (Chromatography systems, Virus Filtration Systems and UFDF and automation systems (e.g. MES, DeltaV))
- Able to work in a high-quality environment (GMP)
- Experience with down steam processing equipment and processes
- Higher professional education (HBO) or university education (WO) in a relevant field
- A focus on excellence and a customer-centric approach
Wensen
- Experience with lean methodologies and project management
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Volledige omschrijving
The role is for an Equipment Engineer Down Stream Processing at a biotech company in Leiden, The Netherlands. As a Downstream Equipment Engineer, you’ll ensure production equipment meets the highest standards. You’ll be a key player in the team, performing project related tasks including new equipment and/or product introduction support, supporting test runs on software and/or equipment, performing operational documentation changes, writing engineering/technical memos, and working closely with related departments like Maintenance, Execution systems and Quality.
You will assist colleagues in routine tasks and tackle more complex challenges with support. Effective communication skills are needed as you interact with both internal and external customers. The impact you will have includes: implementing Operations unit objectives such as supporting new equipment introduction and maintaining existing systems; conducting analysis to identify root causes of equipment failures, downtime and inefficiencies and collaborating with cross-functional teams to develop strategies and implement improvements to minimize downtime; guiding management of routine data collection, analysis, and reporting to drive continuous process improvement; initiating, driving and leading equipment improvements in collaboration with stakeholders, and supporting formal escalation processes to highlight risks related to safety, product quality and regulatory compliance; being the go-to expert for sophisticated Change Control designs from initiation to completion.
Essential requirements: Higher professional education (HBO) or university education (WO) in a relevant field (e.g. pharmaceutical sciences, biotechnology, biochemistry, life sciences, biological engineering); knowledge and/or experience with pharmaceutical production process and equipment lifecycle management; affinity for production equipment (Chromatography systems, Virus Filtration Systems and UFDF and automation systems (e.g. MES, DeltaV); ability to work in a high-quality environment (GMP); a good balance of theoretical and practical insights; a proactive approach with adaptable problem-solving skills; a focus on excellence and a customer-centric approach.
Experience with lean methodologies and project management is a plus.
Bekijk bij SIRE Life Sciences B.V. (opent in een nieuw tabblad)
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