QC Engineer

Lonza; Belgium; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Compensation programs

Global AI/ML scope

Leadership opportunities

Benefits package

Job summary

Lonza in Bornem, Belgium seeks a Dutch-speaking QC Engineer to validate QC laboratory equipment and methods, plan validation activities, and document qualification test evidence. The role involves process and software-related QC testing, ensuring alignment with business processes and SOPs.

The candidate will drive QA-aligned continuous improvement in QC projects, support audits, and assist with CAPA plans, changes, and deviations.

Qualifications

• Master's degree in engineering, pharmacy, biotechnology or equivalent.
• Minimum 2 years engineer experience within quality control environment.
• At least 2 years of relevant experience in a GMP production environment.
• Relevant experience with managing projects or validation.
• Hands-on, pragmatic and a positive problem-solving mindset, able to work in a complex environment with different stakeholders and with continuously evolving developments.
• Clear analytical and problem solving skil

Responsibilities

• Validation: validates QC laboratory equipment and test methods.
• Pro-active scheduling of validation activities and analyses.
• Creates documented evidence of qualification test method as well as validation summaries.
• Follow-up on validation activities linked to business process and software applications by determining or executing appropriate QC tests and SOPs.
• Continuous improvement: participates in department and site related meetings to assure delivery, adherence to quality systems, continuous improvement and customer satisfaction.
• Rolls out various QC projects specific to the laboratory systems or processes, in compliance with applicable standards.
• Drives as well as provides the necessary support to the QC team related to changes and deviations in accordance with internal references.
• Drives the qualification and evaluation process of new products and vendors in cooperation with the QA department.
• Supports customer and regulatory audits to increase customer confidence and satisfaction. Creates and executes CAPA plans.
• Drives training activities on QC related topics to maintain a sustainable quality culture with intrinsically motivated employees.

Education

Master's degree in engineering, pharmacy, biotechnology or equivalent

Job description

QC Engineer (Dutch speaking)

The actual location of this job is in Bornem, Belgium . Relocation assistance is available for eligible candidates and their families, if needed.

The full-time annual base pay for this position in Belgium is expected to range between 52.500,- EUR and 73.500,- EUR. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• The opportunity to shape and scale AI/ML and Data Science capabilities within a global organization.
• Leadership opportunities through mentoring, capability building, and strategic influence.
• A variety of benefits. The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

What you will do:

• Validation
• Validates QC laboratory equipment and test methods.
• Pro-active scheduling of validation activities and analyses
• Creates documented evidence of qualification test method as well as validation summaries.
• Follow-up on validation activities linked to business process and software applications by determining or executing appropriate QC tests and SOPs.

Continuous improvement

• Participates in department and site related meetings to assure delivery, adherence to quality systems, continuous improvement and customer satisfaction.
• Rolls out various QC projects specific to the laboratory systems or processes, in compliance with the applicable standards. Plans, executes and follows-up on project work to ensure on-time completion. Troubleshooting and resolving potential issues followed by communication to stakeholders.
• Installation of test procedures in accordance with regulatory and internal reference test standards (like pharmacopoeia/ food regulations/customer specifications/corporate procedures )
• Drives as well as provides the necessary support to the QC team related to changes and deviations in accordance with internal references.
• Drives the qualification and evaluation process of new products and vendors in cooperation with the QA department.
• Supports customer and regulatory audits to increase customer confidence and satisfaction. Creates and executes CAPA plans.
• Drives training activities on QC related topics to maintain a sustainable quality culture with intrinsically motivated employees.
• undefined

Raw material and batch release

• Combines and analyzes available data on raw material / in process checks / finished products to assure continuous availability of materials meeting the required specifications
• Provides timely correct information on requests from departments and customers related to release process, projects, special testing.
• Identifies trends during release process and material review and suggests corrective and preventive actions with the aim of continuous improvement.
• Drives on time delivery of finished good release and facilitates incoming control at customer.
• Follow-up on QC release activities and decide on fit for use and scrap.Manage, review, and approve OOS (Out of Specification) /deviation investigations, change controls and CAPA. Support the QA deviation coordinator with root cause investigation and determination of appropriate CAPA plans.
• Ensures correct documentation in available quality system as well as impact assessment performance towards product release.

New material release

• creation process by reviewing newly created materials
• Provides support to stakeholders with respect to the quality attribute value selection.
• Distinguishes customized from standard products and assures appropriate COFA installation.
• Key contact for QC related quality attributes issues or actions between different departments.
• Ensures update of QC related software systems when new quality attributes are created. Maintains the fit for use of the new material creation process for future business flows or customer requirements.

What we are looking for:

• Master degree in engineering, pharmacy, biotechnology or equivalent.
• Minimum 2 years engineer experience within quality control environment.
• At least 2 years of relevant experience in a GMP production environment.
• Relevant experience with managing projects or validation.
• Hands-on, pragmatic and a positive problem-solving mindset, able to work in a complex environment with different stakeholders and with continuously evolving developments.
• Clear analytical and problem solving skil