Engineer MSAT Validation, Leiden, Zuid-Holland

The Company A global technology and innovation driven organization focused on advancing healthcare, digital solutions, and consumer products. The company operates across multiple international markets and brings together expertise in engineering, artificial intelligence, product development, and regulatory excellence to deliver impactful solutions. Role description The Senior Innovation Project Manager leads strategic and highly complex innovation programs from concept through market launch. This role drives the development of advanced medical devices, digital health platforms, AI enabled solutions, and consumer technologies while coordinating cross functional teams across multiple locations. The position combines strategic leadership with hands on program execution in a highly regulated environment. Responsibilities - Lead large scale innovation programs across multiple business units and functions - Drive end to end product realization from concept development through launch and lifecycle management - Define program scope, architecture, value creation strategies, timelines, budgets, and risk management plans - Coordinate teams across engineering, software, artificial intelligence, design, regulatory affairs, manufacturing, and supply chain - Ensure compliance with quality systems, product safety requirements, and global regulatory standards - Oversee program governance activities, executive reporting, and stakeholder alignment - Integrate AI and machine learning capabilities into products and development processes - Apply systems engineering principles across hardware, software, cloud, and connected technologies - Support cybersecurity, interoperability, and data governance requirements - Build relationships with external partners, universities, suppliers, and industry collaborators - Monitor market trends, emerging technologies, and competitive developments - Mentor multidisciplinary teams and contribute to organizational capability improvements Requirements - Master's degree in Engineering, Technology, Computer Science, Biomedical Engineering, Systems Engineering, or a related field - Minimum 10 years of experience managing complex multidisciplinary product development or innovation programs - Proven track record of bringing medical devices, digital health solutions, AI powered products, or consumer technologies to market - Experience working with development, supply chain, manufacturing, and regulatory teams - Strong understanding of medical device regulations and standards - Experience with AI and machine learning enabled products or AI driven project management practices - Expert project and program management skills - PMP, IPMA, SAFe, or equivalent certification - Strong stakeholder management and executive communication skills - Ability to lead global cross functional teams in complex environments Other Information Ready to lead breakthrough healthcare and AI innovations? Apply now and help shape the future of technology.

The Company Our client is a leading biotechnology company dedicated to serving patients worldwide. With a strong focus on innovation and quality, they operate a global network that ensures medicines are reliably produced, tested, and distributed. Their culture is built on values, continuous development, and empowering their teams to make a meaningful impact. Job Description We are recruiting for a Quality Assurance Specialist – Qualified Person to join their site in Breda. The role involves ensuring that medicinal products meet all regulatory standards before they are released, supporting the company's commitment to high-quality medicines, and contributing to continuous improvement initiatives within the QA team. Responsibilities - Certify batches of medicinal products and investigational medicinal products in compliance with EU and international regulations. - Collaborate with production, warehouse, distribution, and supply chain teams to ensure adherence to quality policies and procedures. - Act as the primary QA contact for deviations and CAPAs, ensuring investigations and resolutions meet regulatory standards. - Write, review, and approve quality procedures and job aids, ensuring they align with corporate and regulatory requirements. - Support and lead continuous improvement projects through cross-functional teamwork. - Review and sign off on Qualified Person declarations and regulatory documentation to support product filings. Requirements - Eligibility to act as a Qualified Person under EU directive 2001/83/EC article 49. - Master’s degree in Pharmacy, Life Sciences, Medicine, Veterinary Medicine, Chemistry, or related fields. - Minimum of 2 years' practical experience in Good Manufacturing Practice (GMP). - Strong analytical and risk-based decision-making skills. - Excellent communication skills, both written and verbal, with experience in technical writing and stakeholder engagement. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company A leading organization dedicated to maintaining high standards in food safety, quality, and sustainability. The company continuously strives to ensure that its products adhere to strict regulations while fostering a culture of ongoing improvement and excellence in food production. Job Description We are seeking a knowledgeable and proactive Food Safety and Quality Improvement Specialist to join our client's team. The successful candidate will oversee the adherence to food safety and quality standards, drive process improvements, and support certification compliance across production operations. Responsibilities -Ensure compliance with all relevant food safety, quality, and environmental regulations, as well as internal standards. -Maintain, monitor, and continuously enhance the Quality Management System (QMS) and related processes. -Lead and participate in internal and external audits, managing preparation, execution, and follow-up actions. -Oversee certification requirements such as IFS, HACCP, RSPO, and Beter Leven, ensuring timely renewal and compliance. -Serve as the primary point of contact and consultative partner for the QE Manager and production leadership on quality and process issues. -Initiate, coordinate, and support improvement projects aimed at elevating product quality and operational efficiency. -Perform root cause analyses for deviations, complaints, and production issues, implementing sustainable corrective actions. -Oversee the management of process bottlenecks and quality concerns within production, focusing on prevention and risk mitigation. -Collaborate with multidisciplinary teams to develop and implement continuous improvement initiatives. -Manage relationships with external suppliers, laboratories, certification bodies, and pest control services. -Translate data and inspection findings into practical advice and improvement strategies for management and production teams. -Prepare, interpret, and present KPI reports, trend analyses, and performance dashboards. -Facilitate internal training sessions and toolbox meetings on quality and food safety topics. -Promote knowledge sharing within the QE team and maintain an updated understanding of relevant regulations. Requirements -HBO degree in Food Technology, Food & Quality Management, or a related field. -Extensive knowledge of food safety and quality standards: IFS, HACCP, RSPO, Beter Leven. -Experience with audit planning, process control systems, and quality reporting. -Proficient in ERP and QA software tools. -Fluent in Dutch and English, both written and spoken. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

Job Description We are seeking a motivated Cell Therapy Technician to support the production of clinical and commercial cell therapy products in a GMP-regulated aseptic manufacturing environment. In this role, you will collaborate with cross-functional teams to ensure safe, compliant, and efficient manufacturing while maintaining the highest quality standards. Key Responsibilities -Perform manufacturing activities, including aseptic processing, batch documentation, and sample handling. -Prepare growth media in cleanroom environments and carry out material decontamination procedures. -Complete and review batch records to ensure GMP compliance and accurate documentation. -Transfer samples for quality control analysis and perform cryopreservation of excess cells and finished products. -Assist with troubleshooting manufacturing equipment and recommend process improvements. -Participate in continuous improvement and change control initiatives. -Maintain cleanroom standards and ensure manufacturing workstations remain organized and compliant. -Work a rotating shift schedule, including mornings, evenings, and weekends, based on production Requirements -MLO, MBO, or HBO qualification (MBO Level+ or higher) in Life Sciences or a related discipline. -Experience working in a cGMP-regulated pharmaceutical, biotechnology, or similar manufacturing environment. -Understanding of biopharmaceutical manufacturing processes. -Practical experience with aseptic techniques and handling blood-derived products. -Knowledge of Vapro A/B or LITOP A/B is considered an advantage. -Proficiency in Microsoft Office applications, particularly Word and Excel, with basic data analysis skills. -Ability to follow SOPs accurately, work independently, and perform effectively in a dynamic manufacturing environment. -Good verbal and written communication skills in English. Dutch language skills are not required. -Willingness to receive a Hepatitis B vaccination if not already vaccinated. Additional Information Interested in this opportunity? Click the Apply button to submit your application or contact me directly for more information.  

The Company A manufacturing company that produces high quality products using advanced automated production systems. The company works in a GMP regulated environment where safety, quality, and compliance are very important. About the Role As an Automated Production Operator, you will run and monitor automated production machines to ensure products are made safely, efficiently, and according to quality standards. You will help solve machine issues, record production information, and support improvements to production processes. Responsibilities -Manage and monitor automated production equipment -Troubleshoot machine issues and make necessary adjustments -Record and verify production data in SAP and MES systems -Complete GMP documentation and maintain accurate production records -Work with Quality, Engineering, and Production teams to resolve issues -Perform equipment cleaning, basic maintenance, and production line setup -Support process improvements and continuous improvement initiatives -Ensure safe working practices and effective shift handovers Requirements -Minimum 3 years of experience in a similar production or manufacturing role -Experience working with automated production equipment -Experience in assembly and packaging processes is preferred -Good English communication skills -Comfortable following strict procedures and GMP requirements -Willing to work shifts and travel to the work location -Ability to work closely with Quality, Engineering, and Production teams -Experience completing GMP documentation and records -Strong problem solving and troubleshooting skills Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.  

The Company Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety. Role Description As a Cell Therapy Specialist, you are responsible for supporting GMP manufacturing activities within an aseptic cleanroom environment. You will execute production and production-support operations, including material preparation, batch execution, documentation management, and product handling, while ensuring strict compliance with cGMP regulations, SOPs, and quality standards. Responsibilities - Perform daily operational tasks within the manufacturing process, including the transfer and handling of blood products and cell samples. - Support the preparation of growth media and other materials in cleanroom environments. - Assist in reviewing batch documentation to ensure accurate and timely product release. - Conduct material decontamination and supply manufacturing suites with required components. - Prepare, inspect, and cryopreserve final products and excess cells. - Transfer samples to QC for testing and manage sample documentation. - Collaborate with the Production Support Team to perform tasks such as apheresis accession and batch transfer. Requirements - Qualified in MLO, MBO, HBO (MBO level or higher) with a background in Life Sciences. - Experience working in GMP pharmaceutical or biotech manufacturing is essential. - Knowledge of pharmaceutical manufacturing processes for biotechnology products. - Familiar with cleaning and sterilization procedures such as Vapro A and B or LITOP A and B is a plus. - Skilled in Microsoft Word, Excel, and data analysis tools. - Comfortable working in full gowning aseptic environments and adhering to strict GMP protocols. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company Our client is an international pharmaceutical and biotechnology organization with a modern manufacturing facility in Breda. The site combines advanced production technology with strict GMP, quality, and safety standards. To support growing production activities, we are looking for several hands-on professionals who enjoy working with machinery, solving technical problems, and improving production processes.   Job Description As a Production Operations Technician, you will help ensure that manufacturing and packaging equipment performs reliably throughout the production process. You will prepare equipment for production, respond to operational issues, complete required documentation, and contribute to maintaining a safe and efficient manufacturing environment.   Responsibilities - Keep manufacturing and packaging equipment running efficiently throughout production. - Prepare machines for different production runs, including set-ups, changeovers, line clearance, and shutdown activities. - Identify equipment or process issues and carry out first-line troubleshooting. - Perform minor machine adjustments to restore or improve equipment performance. - Complete GMP and production documentation accurately and on time. - Carry out required equipment and production-area cleaning activities. - Follow established GMP, SOP, quality, and safety procedures. - Identify recurring production issues and contribute to reducing downtime and improving efficiency. - Escalate complex technical problems to the appropriate technical specialists. - Collaborate with production, quality, and technical teams to maintain smooth operations. Requirements - MBO-level education or equivalent technical/production experience. - Previous hands-on experience within manufacturing, production, packaging, or process operations. - Experience working with automated or semi-automated production equipment. - Knowledge of GMP, SOPs, or regulated manufacturing procedures. - Experience completing GMP or production documentation. - Familiarity with machine set-ups, changeovers, line clearance, and close-down activities. - Experience performing cleaning activities within a production environment. - Good technical troubleshooting skills and confidence making minor equipment adjustments. - Good communication skills in English. - Willingness to work within a rotating shift schedule. Interested? If you enjoy hands-on technical work, modern production technology, and problem-solving, we would like to hear from you.  

The Company Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety. Role Description As a Cell Therapy Specialist, you are responsible for supporting GMP manufacturing activities within an aseptic cleanroom environment. You will execute production and production-support operations, including material preparation, batch execution, documentation management, and product handling, while ensuring strict compliance with cGMP regulations, SOPs, and quality standards. Responsibilities - Perform daily operational tasks within the manufacturing process, including the transfer and handling of blood products and cell samples. - Support the preparation of growth media and other materials in cleanroom environments. - Assist in reviewing batch documentation to ensure accurate and timely product release. - Conduct material decontamination and supply manufacturing suites with required components. - Prepare, inspect, and cryopreserve final products and excess cells. - Transfer samples to QC for testing and manage sample documentation. - Collaborate with the Production Support Team to perform tasks such as apheresis accession and batch transfer. Requirements - Qualified in MLO, MBO, HBO (MBO level or higher) with a background in Life Sciences. - Experience working in GMP pharmaceutical or biotech manufacturing is essential. - Knowledge of pharmaceutical manufacturing processes for biotechnology products. - Familiar with cleaning and sterilization procedures such as Vapro A and B or LITOP A and B is a plus. - Skilled in Microsoft Word, Excel, and data analysis tools. - Comfortable working in full gowning aseptic environments and adhering to strict GMP protocols. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company Overview: A global leader in biopharmaceuticals that develops innovative products to enhance animal health and wellbeing. With a strong focus on biological R&D, the company operates across multiple locations and employs thousands of professionals dedicated to improving lives through science and technology. Job Description: We are seeking a skilled Transfer Specialist to join the Quality Control team within our Animal Health division. This vital role involves managing the transfer of biological and analytical tests from R&D or other sites to our QC laboratories, ensuring high standards and timely execution. The successful candidate will play a key part in maintaining product quality and supporting ongoing quality improvements. Responsibilities: •    Serve as the expert on various biological and analytical test techniques. •    Manage and ensure the successful transfer of tests according to established transfer methodologies, including new R&D methods and existing tests from other sites. •    Lead or support transfer projects, ensuring they are completed within set timelines. •    Facilitate proper transfer of tests to QC laboratories for commercial batch release. •    Participate in or lead transfer-related activities, including development, implementation, and post-transfer testing. •    Act as the primary contact for deviations, changes, audits, training, and documentation, ensuring compliance with GMP procedures. •    Use Lean Six Sigma tools for problem-solving, process improvements, and continuous quality enhancement. Requirements: •    HBO level education in (micro)biology, analytical chemistry, or similar field. •    Minimum of 5 years’ experience in a biological QC laboratory, preferably within GMP or GLP environments. •    Proven expertise in transfer processes, data analysis, and root cause investigation. •    Experience with change management and project leadership is advantageous. •    Familiarity with SAP, LIMS, and electronic QC data systems. •    Certified Yellow Belt or experienced with Lean/Six Sigma methodologies is a plus. •    Accurate, proactive, and solution-oriented with strong communication skills in English and Dutch. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company  Our Client is a fast-growing European food company specializing in innovative frozen snacks. With a strong focus on quality, sustainability, and consumer trends, GoodLife Foods develops market-leading products enjoyed by customers across Europe Role Description We are seeking a proactive and detail-oriented Production Planning Coordinator to oversee and optimize production schedules. This temporary role involves managing the weekly production plan, ensuring operational efficiency, and aligning production activities with business goals. Responsibilities -Develop and manage the weekly production schedule, working within an 8-week horizon, with the first two weeks locked (“frozen”). -Collaborate closely with production teams to ensure plans are realistic, feasible, and aligned with capacity and staffing levels. -Translate demand and supply guidelines into actionable production plans. Monitor production progress throughout the week and adjust schedules as needed to address delays, disruptions, or changing priorities. -Communicate changes clearly to all relevant stakeholders, including production, logistics, and management. -Document current processes, define planning parameters such as capacity and lead times, and ensure transparency and repeatability of the planning procedures. Requirements -HBO level education, preferably in logistics, supply chain, or production planning. -Experience in a manufacturing environment is a plus. -Strong organizational and analytical skills. -Proficiency with ERP and planning systems, advanced Excel skills. -Logical, structured thinking with a business-oriented mindset. -Independent, proactive, with a passion for optimization. -Excellent communication skills to present insights and recommendations to stakeholders at various levels. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.