Qualification Engineer

About the job

Position Overview

As a Qualification Engineer – Material Agent, your mission is to ensure all materials and services onboarded and maintained throughout their lifecycle comply with internal and external quality standards, while supporting business continuity, cost optimization, and operational improvements. Your impact is critical in qualifying materials, ensuring data compliance, and supporting the transfer, onboarding, and modification of materials and services in a dynamic pharmaceutical manufacturing environment.

Main Responsibilities:

Core business:

• Onboard new materials and services and maintain their lifecycle management.
• Conduct compliance checks for all supplier-initiated changes.

Compliance:

• Research, align, and harmonize local procedures with internal and external (e.g., GMP) standards.
• Identify process gaps and drive efficient compliance solutions, documenting and following up through change controls.

Business Continuity:

• Proactively manage production planning by ensuring viable alternatives are available in case of supply issues.
• Support the team in document migration to new templates, promoting new ways of working.

Cost Management:

• Analyse direct and indirect cost items and propose cost-reduction strategies that preserve quality and supply integrity.

Operational Excellence:

• Set up, optimize, and maintain processes and data systems, leveraging advanced Excel and Power BI tools.
• Support the team’s Continuous Improvement and Operational Excellence (OPEX) objectives.

Project Support:

• Participate in and support specific projects, such as Transfer Out initiatives.

Qualifications and Experience:

• Academic background in Materials Science, Chemistry, Mechanical Engineering, Pharmaceutical Sciences, or equivalent technical discipline.
• Demonstrated affinity and experience with the technical aspects of processes and material management in a pharmaceutical (or similarly regulated) production environment.
• Thorough understanding of GMP and quality systems; experience with compliance and audits is a plus.
• Strong analytical, problem-solving, and project management abilities.
• Intrinsically motivated to work on cross-departmental projects, with interfaces to R&D, MSAT, QC, Manufacturing, Supply Chain, and OPEX.
• Very comfortable working with data and digital systems, especially Excel and Power BI (must), and PowerPoint.
• Outgoing and confident personality, willing and able to engage stakeholders and steer discussions.
• Strong communication skills, confident in constructively challenging ideas and asking clarifying questions.