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Labware/CSV Engineer (Freelance)
Eingestellt von Amoria Bond Ltd
Gesuchte Skills: Engineer, Engineering, Consultant
Projektbeschreibung
Labware/CSV engineer (Freelance)
KEY WORDS: Labware, CSV, Control system validation, validation process, Operational excellence, opex, lean six sigma, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, project, pharma, Blackbelt, Chemical, Chemisch, process industrie, BioAnalysis, IT project manager, IT, CSV, Labware, Bioscience, CSV documentation
Contract length:12 month + possible extension
Type:Freelance
Start date: ASAP
Market rate:Market Average
For a renowned pharmaceutical company in the Brussels region, Amoria Bond is currently looking for a Labware/CSV engineer.
This is a role with broad responsibilities in which you will take up the role of CSV engineer, IT project manager and Labware engineer/consultant and in which you will be closely together with business project leaders and other stakeholders (QA, sponsors, key users etc.). The Labware consultant/CSV engineer will report directly to the IT R&D manager.
The main responsibilities are:
*Lead projects within a pharmaceutical GxP environments
*Orchestrate the CSV documentation
*Collaborate with the Business project managers to set up validation plans
*Oversee and set out the schedules and manage the CSV deliverables
*Act as the point of communication for all involved stakeholders. These include the R&D, the Global Quality and the IT technical teams (Labware developers)
*Participate in functional and technical testing activities
*Coordinate and communicate project status to stakeholders and management
*Write test scripts that will be formally executed
*Write the GxP validation documentation in collaboration with IT Quality Riskbeing able to communicate with every stakeholder in the organization (from developers to management)
*Thorough knowledge in Pharmaceutical quality and R&D lab processes
*Knowledge of pharmaceutical regulatory GxP work environments
*Experience working with industry specific templates/modules such as BioAnalyses, Labware ELB,
*Multiple years provable experience working in roles such as Business analyst, lab process designer or IT project leader in GxP environment
*Thorough knowledge of IT CSV documentation
*University degree in Engineering, Bioscience, Business or other relevant area
If you are interested in this position, please send your CV to (see below) and I'll get in touch with you ASAP.
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
KEY WORDS: Labware, CSV, Control system validation, validation process, Operational excellence, opex, lean six sigma, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, project, pharma, Blackbelt, Chemical, Chemisch, process industrie, BioAnalysis, IT project manager, IT, CSV, Labware, Bioscience, CSV documentation
Contract length:12 month + possible extension
Type:Freelance
Start date: ASAP
Market rate:Market Average
For a renowned pharmaceutical company in the Brussels region, Amoria Bond is currently looking for a Labware/CSV engineer.
This is a role with broad responsibilities in which you will take up the role of CSV engineer, IT project manager and Labware engineer/consultant and in which you will be closely together with business project leaders and other stakeholders (QA, sponsors, key users etc.). The Labware consultant/CSV engineer will report directly to the IT R&D manager.
The main responsibilities are:
*Lead projects within a pharmaceutical GxP environments
*Orchestrate the CSV documentation
*Collaborate with the Business project managers to set up validation plans
*Oversee and set out the schedules and manage the CSV deliverables
*Act as the point of communication for all involved stakeholders. These include the R&D, the Global Quality and the IT technical teams (Labware developers)
*Participate in functional and technical testing activities
*Coordinate and communicate project status to stakeholders and management
*Write test scripts that will be formally executed
*Write the GxP validation documentation in collaboration with IT Quality Riskbeing able to communicate with every stakeholder in the organization (from developers to management)
*Thorough knowledge in Pharmaceutical quality and R&D lab processes
*Knowledge of pharmaceutical regulatory GxP work environments
*Experience working with industry specific templates/modules such as BioAnalyses, Labware ELB,
*Multiple years provable experience working in roles such as Business analyst, lab process designer or IT project leader in GxP environment
*Thorough knowledge of IT CSV documentation
*University degree in Engineering, Bioscience, Business or other relevant area
If you are interested in this position, please send your CV to (see below) and I'll get in touch with you ASAP.
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management