Pharma Compliance Engineer - Quality & Regulatory Expert

MindCapture BV; Belgique; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Training and career development

Job summary

MindCapture in Antwerp is seeking a Medior Compliance Engineer to act as the central point for quality and compliance within engineering and maintenance. You will bridge quality processes with technical activities, supporting investigations and continuous improvement on-site at the client’s facility.

The role demands a versatile professional with strong qualification experience in pharma, knowledge of EudraLex and ICH guidelines, and the ability to drive pragmatic solutions in a regulated

Qualifications

• Approximately 5–10 years of relevant professional experience in engineering compliance, qualification or a comparable technical quality role.
• Solid background in qualification with strong technical affinity.
• Thorough knowledge of pharmaceutical regulations including EudraLex, Annex 1 and ICH guidelines.
• Good understanding of ISPE guidelines and their practical application in pharma engineering and maintenance.
• Experience with QMS processes within a compliance-focused environment is a plus.
• Ability to support technical investigations, root cause analysis, change controls and corrective actions.
• Excellent communication skills across quality, engineering, maintenance and qualification.

Responsibilities

• Quality Management System: Prepare, manage and follow up on quality actions within the departmental QMS to ensure compliance with procedures and regulatory requirements.
• Deviation Management: Coordinate root cause investigations related to technical systems and maintenance processes to identify issues and prevent recurrence.
• Change Control: Prepare and coordinate change controls with production, engineering, qualification and quality stakeholders.
• CAPA Management: Develop and implement effective corrective and preventive action plans.
• Documentation Compliance: Ensure timely periodic reviews of departmental documentation while maintaining compliance with quality standards.
• Technical Compliance Support: Provide guidance to engineering and maintenance on compliance requirements and quality processes.
• Stakeholder Collaboration: Act as central contact between quality, engineering, maintenance and qualification for alignment on compliance expectations.
• Continuous Improvement: Identify opportunities to strengthen quality processes and implement pragmatic solutions.

Skills

Qualification expertise

Pharmaceutical regulations

Deviation management

CAPA management

QMS processes

Autonomous working

Pragmatic approach

Job description

MindCapture in Antwerp is seeking a Medior Compliance Engineer to act as the central point for quality and compliance within engineering and maintenance. You will bridge quality processes with technical activities, supporting investigations and continuous improvement on-site at the client’s facility.

The role demands a versatile professional with strong qualification experience in pharma, knowledge of EudraLex and ICH guidelines, and the ability to drive pragmatic solutions in a regulated