QC Engineer

Lonza Group; Bornem; Remote; EUR 53,000 - 74,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

AI/ML capability development

Leadership opportunities

Job summary

Lonza in Bornem, Belgium, is seeking a QC Engineer to drive QC validations, product release processes, and continuous improvement of control strategies. You will collaborate with manufacturing to ensure high product quality and on-time delivery, with a focus on validation, release, and CAPA initiatives.

The role offers an agile, inclusive workplace with opportunities to shape AI/ML capabilities within a global organization and leadership growth through mentoring and capability building.

Qualifications

• 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.
• Hands-on, pragmatic and problem-solving mindset with stakeholders.
• Analytical and proactive with solution-focused mindset.
• Fluent Dutch and English communication; French is an advantage.

Responsibilities

• Validates QC laboratory equipment and test methods.
• Pro-active scheduling of validation activities and analyses.
• Creates documented evidence of qualification test method and validation summaries.
• Follow-up on validation activities linked to business process and software applications.
• Participates in meetings to assure delivery and quality systems.
• Drives QC projects in lab systems/processes in line with standards.
• Installs test procedures per regulatory and internal standards.

Skills

GMP experience

Project management

Problem solving

Analytical skills

Dutch and English communication

Team collaboration

MS Office / ERP tools

Education

Master degree in engineering or related field (engineering/pharmacy/biotech)

Tools

MS Office

ERP systems

Statistical packages

Job description

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

For our site in Bornem we have an open position for a QC Engineer. In this role, you will drive QC validations, product release processes and support lean and efficient control strategies. You will initiate quality improvement projects which will enable us to keep our position as ‘leader in quality’ in the market. You will work closely with the manufacturing organization to safeguard high product quality levels and delivery service according to customer expectations.

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.

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 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.
• 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 skills, proactive, persistent, result driven
• Ability to interact, cooperate and motivate across departments and functions
• Ability to work independently while being a team player with collaborative skills
• Possesses a positive, can‑do attitude and creatively solves problems
• Good knowledge of IT-tools: MS Office / Statistic packages / ERP-tools and -processes.
• Fluent written and oral communication in Dutch and English,
• French is an advantage.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R80490

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.