Remote Validation Engineer - Computerized Systems (Pharma)

Amaris Consulting; Geel; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a Validation Engineer – Computerized Systems to plan, execute and maintain validation activities for cGMP‑critical software in a regulated environment, ensuring systems stay validated and compliant.

You will work across QA, IT, engineering and business stakeholders, prepare validation documentation, and provide hands‑on validation execution and issue resolution. Strong English and Dutch skills are required.

Qualifications

• 3+ years of experience in the pharmaceutical sector and GMP environment.
• Solid knowledge of Computer Systems Validation and relevant quality/compliance regulations (e.g. GxP, data integrity, FDA/EU guidelines).
• Experience validating software packages and computerized systems from planning to execution and documentation.
• Strong troubleshooting skills for validation and system issues.
• Able to work independently, learn quickly and execute projects according to plan.
• Strong communication skills, able to interact with QA, IT, engineering and business stakeholders.
• Good command of English and Dutch (spoken and written).

Responsabilités

• Plan, execute and maintain validation activities for cGMP‑critical software in a GMP environment.
• Prepare validation documentation (protocols and reports) and support hands‑on execution.
• Ensure validation documents are reviewed, approved and implemented, maintaining validated state.
• Validate systems per industry standards in line with cGMP, cGLP and internal procedures.
• Ensure projects comply with Sanofi procedures and regulatory standards.
• Stay current on validation regulations and provide input on US FDA and EU requirements.
• Assess changes for impact on validated status and define validation needs.
• Investigate and troubleshoot validation issues and implement corrective actions.

Connaissances

GxP compliance

Validation experience

Software validation

Troubleshooting

Independent work

Stakeholder communication

English & Dutch

Description du poste

Amaris Consulting is seeking a Validation Engineer – Computerized Systems to plan, execute and maintain validation activities for cGMP‑critical software in a regulated environment, ensuring systems stay validated and compliant.

You will work across QA, IT, engineering and business stakeholders, prepare validation documentation, and provide hands‑on validation execution and issue resolution. Strong English and Dutch skills are required.