Process Validation Engineer Cell Therapy

MindCapture; Belgique; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Expense allowance

Company car with charging card

Résumé du poste

MindCapture is seeking a Process Validation Engineer for Cell Therapy to join a consultancy role, on site with a client in Antwerp. You will drive continued process verification and particle governance for cell therapy manufacturing, collaborating with quality, QA and manufacturing teams.

You will collect, structure and analyze manufacturing data, perform statistical trending and support cross-functional governance.

Qualifications

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences, pharmacy or a related discipline.
• Five to seven years of relevant professional experience.
• Experience within pharmaceutical, biotechnology, cell therapy or related regulated industry.
• Knowledge of GMP and manufacturing processes.
• Ability to perform statistical trending and interpret process data.
• Strong reporting and cross functional collaboration skills.
• Experience with cleanroom environments is a plus.

Responsabilités

• Support continued process verification activities with manufacturing science, technology transfer and quality stakeholders.
• Collect and structure manufacturing data and perform statistical trending.
• Contribute to continued process verification reporting and governance.
• Assess current particle monitoring processes and develop improved mitigation approaches.
• Document batch documentation and deviation information with cross functional teams.
• Develop and present data, trends, risk assessments and improvements.

Connaissances

GMP knowledge

Data analysis

Statistical trending

Cross-functional work

Project management

Cleanroom experience

Manufacturing knowledge

Communication skills

Independent work

Formation

Bachelor degree in engineering or life sciences

Description du poste

Jobs / Process Validation Engineer Cell Therapy

Process Validation Engineer Cell Therapy

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card


• Personal growth support with tailored training and clear career development


• A stable environment where your technical skills directly contribute to improved patient care


• The chance to work with high tech diagnostic systems at top tier healthcare institutions


• A warm and collaborative culture focused on trust, ownership and long term impact

As Process Validation Engineer, you will support continued process verification activities for our client, working closely with manufacturing science, technology transfer and quality stakeholders. You will collect and structure manufacturing data, perform statistical trending and contribute to continued process verification reporting. You will also support particle governance by assessing current processes, monitoring particulate trends, investigating deviations and developing improved monitoring and mitigation approaches.

Key responsibilities

• CPV reporting: Gather data, draft report sections and support preparation and approval of annual continued process verification reports


• Data management: Extract and structure manufacturing and analytical data from manufacturing, laboratory and enterprise systems


• Statistical trending: Analyse Critical Process Parameters and Critical Quality Attributes using statistical analysis software


• Process monitoring: Identify potential process drift, out of trend results and manufacturing variations for further investigation


• Cross functional coordination: Work with quality and technical specialists to obtain missing batch documentation and deviation information


• Process mapping: Document current particle monitoring processes including sampling points, inspection methods and data flows


• Particle trending: Monitor visible and subvisible particulate data, investigate deviations and contribute to root cause identification


• Governance design: Develop improved particle monitoring strategies, alert limits, action limits and handling approaches


• Technical governance: Present technical data, trends, risk assessments and proposed improvements to cross functional stakeholders

Required competences & skills

• Education: Bachelor degree or higher in engineering, biotechnology, biomedical sciences, pharmacy or a related discipline


• Experience: Five to seven years of relevant professional experience


• Industry background: Experience within pharmaceutical, biotechnology, cell therapy, plasma derived products or a related regulated industry


• Manufacturing knowledge: Experience introducing pharmaceutical products into manufacturing environments and knowledge of manufacturing unit operations


• GMP knowledge: Strong working knowledge of current Good Manufacturing Practices


• Data analysis: Ability to perform statistical trending and interpret manufacturing process data


• Project management: Ability to provide timely and accurate reporting on project activities to colleagues and leadership


• Collaboration: Ability to communicate effectively with stakeholders across different organisational levels


• Independence: Ability to prioritise tasks, manage time and make decisions while working independently under general direction


• Cleanroom experience: Experience working under aseptic conditions in a controlled cleanroom environment is a plus

Quality & Compliance Antwerp Medior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.

Explore other jobs in Quality & Compliance

• Support global change controls for manufacturing processes


• Coordinate stakeholders across quality and operations


• Enable tech transfers and continuous improvement


• Drive process verification within cell therapy manufacturing


• Analyse manufacturing data to identify trends


• Strengthen governance through monitoring and investigation


• Maintain compliant industrial IT systems within operations


• Coordinate validation, maintenance and investigations


• Bridge operational technology, IT, quality and business


• Review qualification documentation using risk based methods


• Support compliance, investigations, audits and CI


• Perform quality control within a regulated environment


• Analyse samples using analytical techniques


• Ensure accurate documentation while following GMP


• Take ownership of broad QA responsibilities in GMP


• Manage deviations, audits and compliance related activities


• Drive quality improvements through investigations


• Provide quality oversight for cleaning validation activities


• Ensure compliance across validation processes


• Guide stakeholders on risk based quality decisions effectively


• Lead quality assurance in a growing biopharma environment


• Strengthen compliant quality systems


• Guide audits and improvement initiatives


• Execute validation of GMP critical computerised systems


• Ensure compliance with FDA and EU regulatory standards


• Generate validation documentation and resolve issues


• Maintain and troubleshoot lab equipment in GMP setting


• Ensure compliance with cGMP standards and safety guidelines


• Support upgrades and continuous improvement initiatives


• Perform QC testing for cell therapy products


• Ensure compliance with GMP and regulatory standards


• Collaborate on tech transfer and quality documentation


• Drive quality strategy for global computerised systems


• Ensure validation in line with GMP requirements


• Lead audits, inspections and compliance risk assessments


• Build, implement and maintain Quality Management Systems


• Manage deviations, CAPAs and change control processes


• Prepare for and support audits and inspections