15 beste vacatures voor de functie van data engineer in waterloo (nieuwe medewerkers gezocht)

Senior CSV Data Integrity Engineer
PM Group —Brussel
- Managementervaring
11 uur
ACPV Senior Data Engineer
Vector Synergy —Eigenbrakel
- Bachelor
Snel solliciteren
6 dagen
Provide Data Engineering Support Services to the NATO Cyber and Digital Transformation Division
Vector Synergy —Brussel
- API's
- Python
Snel solliciteren
Data Engineering Manager - Financial Services
EY —Diegem
- Deeltijds
- Computerwetenschappen
- Azure
- Informatica
MISP Senior Data Engineer
Vector Synergy —Brussel
- Scripting
- Python
Snel solliciteren
17 uur
Senior Power BI Developer
Thoughtlabs —Brussel
- Deeltijds
- SQL
Data Analytics Engineer
Elmos —Brussel
- Azure
- SQL
13 dagen
Data Engineer - GenAI
Artefact —Brussel
- Computerwetenschappen
- Azure
- Engels
Senior Data Integrator
Expleo —Brussel
- Computerwetenschappen
- Azure
- Informatica
Senior Java Developer (Data & GIS) voor Databank Ondergrond Vlaanderen (DOV)
Vlaanderen Connect. —Brussel
- € 4.840 - € 6.500 per maand
- Deeltijds
- Java
- SQL
- JavaScript
- Thuiswerkopties
- Pensioensparen
2 dagen
Ingénieur Travaux F/H – Data Centers
Technord —Feluy
- € 4.300 per maand
- Voltijds
- Chantier
- Engels
- Master
Snel solliciteren
1 dag
Senior Data Scientist – MMM Expert
Artefact —Brussel
- Computerwetenschappen
- Master
- SQL
Functional Data Engineer - HQ Brussel
BNP Paribas Fortis —Brussel
Microsoft Business Intelligence Expert - MS Fabric
Devoteam Belgium —Machelen
- Voltijds
- Hybride werken
- Azure
- Engels
- SQL
Snel solliciteren
Senior Data Scientist - GenAI
Artefact —Brussel
- Computerwetenschappen
- Management
- Doctoraat

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Senior CSV Data Integrity Engineer

PM Group -
Brussel

Nu solliciteren

Vacaturegegevens

11 uur geleden

Kwalificaties

Frans
DCS
Managementervaring

Volledige vacaturetekst

Due to large scale pharmaceutical project wins we now wish to recruit a Senior CSV Engineer to join our OTS-team based at a client site.

The candidate will join the client's project within the Commissioning, Qualification & Validation (CQV) environment. The mission is focused on Computer System Validation (CSV) and, most importantly, Data Integrity for GMP systems across multiple project areas including utilities, drug substance, drug product and analytical laboratories.

The primary focus of the role (approximately 80%) is Data Integrity, especially Data Integrity Risk Assessments (DIRA). The mission is planned to start as soon as possible and currently runs until the end of the year, with possible extension.

Team info:

The candidate will work within an integrated cross-functional team involving quality, IT specialists, process data owners, system owners and other project stakeholders. The candidate will collaborate with approximately 10 to 20 stakeholders across various project streams and will act as the key driver for Data Integrity activities while coordinating with multiple functions.

Day to day:

- Act as CSV & Data Integrity Subject Matter Expert and compliance lead.
- Lead CSV Commissioning & Qualification activities throughout the project lifecycle.
- Perform and drive Data Integrity Risk Assessments (DIRA) and gap analyses.
- Ensure compliance with 21 CFR Part 11 requirements.
- Review and assess:
  - Audit trails
  - Electronic records and electronic signatures
  - System security
  - Access management
  - Data import/export processes
  - Backup and disaster recovery processes
  - Reporting functionalities
- Coordinate with IT and compliance teams for implementation and testing activities.
- Support process automation validation activities for EMS, BMS, PCS/DCS and SCADA systems.
- Review automation design documentation, configuration verification and testing activities.
- Participate in interface testing, IO loop testing, alarm management, interlocks, control loops and trending verification.
- Support validation of PLC-controlled equipment including WFI generation, decontamination stations, lab water systems and filling lines.
- Draft, review and approve validation documentation, test protocols and final reports.
- Drive deviation investigations, troubleshooting and resolution of CSV-related issues.
- Review and manage change controls related to CSV and qualification activities.
- Ensure training compliance for personnel involved in C&Q activities.
- Coordinate stakeholders and actively drive deliverables to completion.

This is a senior expert role where the candidate is expected to act as a Subject Matter Expert, providing leadership, guidance and driving Data Integrity and CSV activities from design through execution and final approval.

Minimum 8-10 years of relevant experience preferred.
At least 5+ years of experience as CSV/Data Integrity Lead, SME or senior expert within international CAPEX projects.
Strong pharmaceutical or biotechnology industry experience is considered mandatory.
Proven experience delivering CSV Commissioning & Qualification activities in GMP-regulated environments.

Must have:

Expert-level knowledge of Data Integrity principles.
Strong hands-on experience with DIRA execution and gap analysis.
Deep knowledge of 21 CFR Part 11.
Extensive CSV Commissioning & Qualification experience.
Pharmaceutical and/or biotechnology industry experience.
Experience with GMP-regulated systems and environments.
Strong understanding of risk-based CSV approaches.
Knowledge of:
- GAMP 5
- ISPE best practices
- Annex 15 GMP EU
- Annex 1 GMP
- ASTM E2500
Experience reviewing audit trails, electronic records and electronic signatures.
Ability to lead stakeholders and drive activities independently.
Strong communication and leadership skills.
Ability to collaborate with senior stakeholders.
Hands-on mindset with the ability to hit the ground running.
Technical degree in Engineering or equivalent qualification.
Fluent professional English.

Nice to have:

Experience with process automation systems (EMS, BMS, DCS, SCADA).
Experience with PLC-controlled GMP equipment.
Exposure to inspections and presenting Data Integrity topics during audits.
Experience with sterile, biotech and single-use technologies.
French language skills. (not mandatory but an advantage)
Experience with electronic execution environments.

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data engineer vacatures in waterloo

Senior CSV Data Integrity Engineer

ACPV Senior Data Engineer

Provide Data Engineering Support Services to the NATO Cyber and Digital Transformation Division

Data Engineering Manager - Financial Services

MISP Senior Data Engineer

Senior Power BI Developer

Data Analytics Engineer

Data Engineer - GenAI

Senior Data Integrator

Senior Java Developer (Data & GIS) voor Databank Ondergrond Vlaanderen (DOV)

Ingénieur Travaux F/H – Data Centers

Senior Data Scientist – MMM Expert

Functional Data Engineer - HQ Brussel

Microsoft Business Intelligence Expert - MS Fabric

Senior Data Scientist - GenAI

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van data engineer in waterloo

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