Compliance Engineer – Engineering & Maintenance

Pauwels Consulting; Geel; On-site; EUR 65,000 - 95,000; Full time

Job summary

Pauwels Consulting is seeking a Compliance Engineer to serve as the primary point of contact for quality and compliance in their technical operations. You will bridge engineering, maintenance and qualification, ensuring alignment with strict quality standards.

The role requires 5+ years in a compliance role within pharma, strong regulatory knowledge (Eudralex, Annex 1, ICH, ISPE), and excellent communication in English, with a pragmatic, proactive approach.

Qualifications

• 5+ years of experience in a compliance-oriented role within the pharmaceutical industry.
• Solid background in qualification and a strong technical affinity.
• Thorough knowledge of industry regulations (Eudralex, Annex 1, ICH, ISPE).
• Proactive, solution-oriented with a pragmatic approach to technical challenges.
• Excellent communication and ability to work independently in a multidisciplinary environment.
• Fluent in English.

Responsibilities

• Manage and follow up on actions within the departmental Quality Management System (QMS).
• Coordinate root cause investigations for deviations involving technical systems and maintenance processes.
• Develop and oversee change controls in collaboration with production, engineering, and quality stakeholders.
• Support the creation of CAPA plans and periodic review of departmental documentation.
• Provide technical and compliance-related guidance to engineering and maintenance teams.

Tools

Veeva or QMS (Quality Management System)

Job description

Our client is seeking a Compliance Engineer to serve as the primary point of contact for quality and compliance matters within their technical operations. This role bridges the gap between engineering, maintenance, and qualification by ensuring all processes align with rigorous quality standards.

Responsibilities

• Manage and follow up on actions within the departmental Quality Management System (QMS).
• Coordinate root cause investigations for deviations involving technical systems and maintenance processes.
• Develop and oversee change controls in collaboration with production, engineering, and quality stakeholders.
• Support the creation of CAPA plans and manage the periodic review of departmental documentation.
• Provide technical and compliance-related guidance to the engineering and maintenance teams.

Requirements

• You have 5+ years of relevant experience in a compliance-oriented role within the pharmaceutical industry.
• You bring a solid background in qualification and a strong technical affinity.
• You possess thorough knowledge of industry regulations, including Eudralex, Annex 1, ICH, and ISPE guidelines.
• You're a proactive, solution-oriented professional with a pragmatic and decisive approach to technical challenges.
• You have excellent communication skills and the ability to work independently in a multidisciplinary environment.
• You are fluent in English.

Nice to Haves

• Experience working with Veeva or similar Quality Management Systems.