GMP Equipment Qualification Engineer

AMARIS GROUP SA; Oost-Vlaanderen; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a dedicated Equipment Qualification professional to drive qualification activities in GMP environments within pharma/biotech sectors. You will manage documentation, coordinate testing and collaborate with QA and cross‑functional teams to ensure quality and regulatory compliance.

You will act as the technical owner for assigned systems, oversee IQ/OQ/PQ activities, and address deviations and investigations while maintaining lifecycle processes and continuous

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology or a related technical field.
• Experience in equipment qualification and commissioning within pharma/biotech.
• Fluent in Dutch and English.

Responsibilities

• Coordinate equipment and utilities qualification activities to ensure compliance and timelines.
• Manage technical content of qualification documentation (URS, SRS, DQ, IQ, OQ, PQ).
• Act as technical owner for assigned systems and provide support for qualification questions.
• Assess projects, deviations, investigations and non‑compliance for impact on qualification.
• Review and approve qualification documentation and test records for accuracy and compliance.
• Collaborate with QA and cross‑functional teams to ensure documentation is reviewed and approved.
• Monitor progress, coordinate testing and ensure resources and materials are available.
• Manage deviations and quality issues using quality management systems.
• Maintain qualification processes and lifecycle activities.
• Contribute to continuous improvement and qualification training.

Skills

Equipment qualification

IQ/OQ/PQ

GMP knowledge

Documentation review

Cross-functional collaboration

Analytical thinking

Education

Engineering degree

Life Sciences/ Biotechnology background

Tools

TrackWise

Job description

Amaris Consulting is seeking a dedicated Equipment Qualification professional to drive qualification activities in GMP environments within pharma/biotech sectors. You will manage documentation, coordinate testing and collaborate with QA and cross‑functional teams to ensure quality and regulatory compliance.

You will act as the technical owner for assigned systems, oversee IQ/OQ/PQ activities, and address deviations and investigations while maintaining lifecycle processes and continuous