GMP Asset Engineer: Equipment Qualification & Commissioning

Mantu; Oost-Vlaanderen; Hybrid; EUR 70,000 - 90,000; 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 qualified specialist to lead equipment qualification activities in pharmaceutical/biotech settings. You will manage CQ documents and provide technical ownership across IQ/OQ/PQ, liaising with QA and cross-functional teams.

The role requires GMP knowledge, Dutch and English fluency, and experience coordinating qualification projects with a focus on continuous improvement and regulatory alignment.

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology or related technical field.
• Experience in equipment qualification and commissioning within the pharmaceutical or biotechnology industry.
• Fluent in Dutch and English.
• Good knowledge of GMP requirements and relevant regulatory guidelines.
• Experience with qualification documentation and testing activities, including IQ, OQ and PQ.
• Knowledge of quality management processes, including deviations, change control, investigations and corrective actions.
• Experience reviewing technical documentation and coordinating qualification activities across multidisciplinary teams.
• Familiarity with quality management systems and documentation tools such as TrackWise, is an asset.

Responsibilities

• Coordinate equipment and utilities qualification activities, ensuring compliance with applicable quality standards, regulatory requirements and project timelines.
• Manage the technical content of equipment qualification documentation, including URS, SRS, DQ, IQ, OQ, PQ, qualification plans, reports and related documentation.
• Act as a technical owner for assigned systems, providing technical support and addressing qualification-related questions and issues.
• Assess projects, changes, modifications, deviations, investigations and non-compliance issues to determine their impact on qualification activities.
• Review and approve qualification documentation and executed test records, ensuring accuracy, completeness and compliance.
• Collaborate with Quality Assurance and cross-functional teams to ensure qualification documentation is reviewed and approved.
• Monitor project progress, coordinate testing activities and ensure the availability of required resources and materials.
• Manage deviations, corrective actions and quality issues using relevant quality management systems.
• Maintain qualification processes, including periodic reviews, change evaluations and qualification lifecycle activities.
• Contribute to continuous improvement initiatives, internal and external inspections, and qualification training activities.
• Support team members through technical guidance, knowledge sharing and onboarding when required.
• Ensure all activities are performed in accordance with Good Manufacturing Practices (GMP) and applicable regulatory guidelines.

Skills

Analytical thinking

Problem solving

Communication

Team collaboration

Education

Degree in Engineering, Life Sciences, Biotechnology

Tools

TrackWise

Job description

Amaris Consulting is seeking a qualified specialist to lead equipment qualification activities in pharmaceutical/biotech settings. You will manage CQ documents and provide technical ownership across IQ/OQ/PQ, liaising with QA and cross-functional teams.

The role requires GMP knowledge, Dutch and English fluency, and experience coordinating qualification projects with a focus on continuous improvement and regulatory alignment.