CSV QC Engineer

Akkodis; Waver; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Permanent contract

Competitive salary package

International group environment

Résumé du poste

Akkodis België is op zoek naar een CSV QC Engineer om te zorgen voor de validatie en qualification van QC laboratoriumsystemen in een GMP/GxP omgeving.

Je ondersteunt validatie van laboratoriumsoftware (LIMS, CDS) en apparatuur, bereidt URS/FS/Risk Assessments en IQ/OQ/PQ-protocollen voor, voert tests uit volgens goedgekeurde protocollen en werkt nauw samen met QC, IT en Engineering.

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Computer Science, Automation or related field.
• Good knowledge of cGMP and/or GLP expectations.
• Advanced written and verbal communication skills.

Responsabilités

• Support CSV validation of QC laboratory systems in a GMP/GxP setting.
• Validate laboratory computerized systems and equipment (LIMS, CDS, instruments).
• Prepare and review URS, Functional Specs, Risk Assessments, Validation Plans, IQ/OQ/PQ, and Validation Reports.
• Execute validation tests per approved protocols.
• Ensure compliance with GMP/GxP, FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+.
• Collaborate with Quality Control, IT, Engineering and external vendors.

Connaissances

Communication skills

Pressure handling

Organization

Team collaboration

Formation

Bachelor’s or Master’s degree in Life Sciences / CS / Automation

Outils

LIMS

CDS

IQ/OQ/PQ testing

Description du poste

? Who we are

Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen.

In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.

Akkodis is part of the Adecco Group. You can find more information on our website : www.akkodis.com

CSV QC Engineer

Your responsibilities:

• Support the Computerized System Validation (CSV) of QC laboratory systems in a GxP-regulated environment.
• Validate and qualify laboratory computerized systems and equipment, such as LIMS, CDS, analytical instruments, and other QC applications.
• Prepare and review URS, Functional Specifications, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, and Validation Reports.
• Execute and document validation and qualification tests in accordance with approved protocols.
• Ensure compliance with GMP/GxP requirements, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity / ALCOA+ principles.
• Support the validation of analytical instruments and laboratory equipment used by QC teams.
• Manage deviations, CAPAs, Change Controls, and incidents related to validated QC systems.
• Perform risk assessments and impact assessments for computerized systems and laboratory equipment.
• Participate in periodic reviews and ensure the validated state of QC systems throughout their lifecycle.
• Collaborate closely with Quality Control, Quality Assurance, IT, Engineering, and external vendors.
• Ensure proper documentation, traceability, and data integrity of QC computerized systems.
• Support internal/external audits and regulatory inspections related to CSV and QC systems.

Your profile:

o You have a bachelor’s or master’s degree related to Life Sciences, Computer Science, Automation, Bioengineering or related study.

o You have good knowledge regarding cGMP and/or GLP expectations.

o You have advanced written and verbal communication skills.

o You are French fluent, and English is a plus.

o You know how to handle pressure situations.

o You are organized, proactive, solution-oriented, open-minded, and flexible.

o You enjoy meeting and speaking with people, presenting results by going straight to the point, and advising costumers.

What’s the offer you can’t refuse?

As an AKKODIS Team member, you will be:

o Onboarded in your position via a buddy process and supported in your career by your Business Manager.

o Actor of your training plan and your personal and professional development.

o Benefit from a full time permanent AKKODIS contract with competitive salary package including several extra-legal benefits.

o In a nice work environment & atmosphere within an international group.

o Invited to attractive events calendar including afterwork, life sciences meeting, and other professional gatherings.