Quality Operational Readiness Engineer

Our client, a pharmaceutical organization, is seeking an experienced professional to ensure quality readiness and compliance for the startup of a new production facility. The role coordinates quality-related activities during the facility qualification phase to ensure a seamless transition from construction to operational status. This position maintains full regulatory compliance and GMP standards throughout the commissioning process.

• Conduct quality risk assessments for new processes and procedures during the facility startup.
• Review qualification documentation including DQ, IQ, OQ, and PQ protocols and reports.
• Manage quality event investigations including root cause analysis and CAPA implementation.
• Assess change control requests for quality impact and ensure proper documentation and approval.
• Support regulatory submission activities and preparation for pre-approval inspections (PAI).
• Maintain quality management system documentation and ensure adherence to local and international GMP requirements.
• Provide real-time quality support to project teams through routine GEMBA walks.

• Bachelor's degree in Life Sciences, Engineering, or Quality Management.
• You have 3+ years of experience in pharmaceutical or biotech Quality Assurance.
• You bring a solid understanding of pharmaceutical manufacturing processes and technologies.
• You possess strong analytical and problem-solving abilities with experience in stakeholder management.
• You are fluent in English.

Nice to Haves

• Understanding of risk management and change management principles and methodologies.
• Experience working with external contractors in a project-driven environment.

• 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.