Quality SME - Engineering & Equipment

Our client, a leading pharmaceutical organization, is looking for a Quality SME to support a significant capacity expansion project at one of their sites. This role ensures that engineering processes and equipment systems comply with regulatory standards from the design phase through to operational release.

• Ensure GMP requirements are integrated into the design of equipment and systems.
• Provide quality oversight throughout the construction, installation, and commissioning phases.
• Develop procedures for operation and maintenance while ensuring release approval prior to GMP use.
• Manage engineering quality processes, including procedure updates and the definition of training strategies.
• Lead working groups to integrate expansion phases with existing operational processes.
• Identify scope and team members to drive action plans while ensuring timelines and quality standards are met.

• You bring 5+ years of experience in GMP quality assurance within a pharmaceutical or biotech engineering environment.
• You possess expertise in quality oversight for commissioning, qualification, and equipment design.
• You have experience managing engineering quality processes and developing implementation strategies throughout a project lifecycle.
• You're able to lead cross-functional working groups and manage complex project portfolios.
• You're proactive and solution-oriented with strong communication and reporting skills.
• You are fluent in English.

Nice to Haves

• Prior experience with large-scale facility expansion projects.
• Participation in vendor selection processes for specialized pharmaceutical equipment.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.