Senior Quality Systems Specialist, Hoofddorp, Noord-Holland

Duration: 6 months Location Hoofddorp    About our client Our client is a leading biopharmaceutical company focused on developing innovative treatments for cancer. The organisation operates a GMP-regulated manufacturing site in the Netherlands and works within a highly regulated quality environment. You will join a Quality Systems team that works across the site and collaborates with multiple departments to maintain and continuously improve the quality management system. About the position We are looking for a Senior Specialist I – Quality Systems for a 6-month assignment. In this role, you will support the management and continuous improvement of key Quality Systems, with a strong focus on Change Control, Deviations, CAPA, Material Review and quality metrics. You will work closely with different departments across the site, provide training on Quality Systems and support quality governance and compliance activities. Responsibilities Manage and maintain Change Control, Deviation and CAPA systems Support and act as backup chair for relevant quality review boards Manage the Material Review Board process Deliver and coordinate Quality Systems training Monitor site compliance with quality procedures and requirements Review and approve changes to systems and procedures Review and approve deviations and CAPAs Track and report quality metrics and management information Support Quality Management Reviews, audits and regulatory inspections Ensure proper maintenance of the Quality Management System and cGMP documentation Identify quality risks and opportunities for process improvement Work with cross-functional and cross-site stakeholders Support the team with day-to-day Quality Systems activities Requirements Bachelor’s or Master’s degree in a technical discipline such as Chemistry, Microbiology, Engineering or similar Minimum 5 years of Quality Assurance experience in a GMP environment Strong experience with Change Control, Deviations and CAPA Working knowledge of EU GMP and ICH Q10 Experience with Quality Systems and quality governance Strong knowledge of aseptic manufacturing processes Experience working with quality metrics and review boards Strong written and verbal communication skills Able to work independently with scientific and technical personnel Flexible, pragmatic and a strong team player Experience with ATMPs / cell and gene therapy is an advantage Experience with Power BI, Power Automate, Smartsheet or similar tools is an advantage  

About our client Our client is a global biotechnology company developing and manufacturing innovative medicines for patients worldwide. The Breda site is a large-scale manufacturing operation focused on the assembly, inspection, labeling and packaging of pharmaceutical products. The site operates in a highly regulated GMP environment, where reliable equipment, automation and data integrity are essential to maintaining safe, compliant and efficient production.   About the position We are looking for a Senior Automation Engineer to join the Equipment Engineering team in Breda. In this role, you will take ownership of the automation side of new and upgraded manufacturing equipment — from design and vendor testing through installation, qualification and operational handover. You will work closely with Engineering, Manufacturing, Maintenance, IT and external equipment suppliers to make sure automation systems are reliable, secure, compliant and ready for production. This is a hands-on role for someone who enjoys combining automation engineering, project execution and troubleshooting in a regulated manufacturing environment.   Responsibilities Lead the automation activities for new and upgraded manufacturing equipment. Review and develop automation design documentation, including URS, FDS, HDS and SDS. Support FAT, commissioning, testing and qualification activities. Work with PLC, HMI, SCADA, industrial PC and vision systems. Ensure equipment meets required automation, cybersecurity and data integrity standards. Support equipment integration with site systems, including the PI data historian. Develop and maintain backup/restore, parameter and audit-trail procedures. Support automation troubleshooting and provide on-floor hypercare during implementation. Assess preventive maintenance requirements and automation spare parts. Maintain equipment documentation and asset parameter lists. Train Maintenance, Engineering and relevant Operations teams. Report project progress and technical risks to project management. Support New Product Introduction (NPI) activities at the site.   Requirements Bachelor’s or Master’s degree in Automation Engineering, Industrial Automation, Industrial Information Systems or a related discipline. 5+ years of experience with automation/process control and information systems in pharmaceutical or biotechnology manufacturing. Proven experience with labeling and/or packaging equipment. Practical knowledge of PLC, HMI, SCADA, industrial PCs and vision systems such as Cognex. Experience working in a GMP/regulatory manufacturing environment. Experience delivering automation projects in cross-functional or international teams. Strong understanding of equipment implementation, testing and commissioning. Able to troubleshoot technical issues and translate them into practical solutions. Strong communication and stakeholder-management skills. Fluent English, written and spoken.

About the Company Join a leading biotechnology company at the forefront of immunotherapy and engineered T cell therapy, revolutionizing cancer treatment with individually tailored therapies. Located in Hoofddorp, our client offers a dynamic, fast-paced, and ever-evolving environment where groundbreaking discoveries are made daily. About the Position We are seeking a motivated QC Microbiology Analyst (Microbiologist I) to join a diverse and collaborative team. In this role, you will perform essential microbiological assays and environmental monitoring to support innovative cancer immunotherapies. You will report to one of the Team Leads QC Microbiology and work alongside a team of 20+ professionals. Responsibilities Conduct environmental monitoring of cleanrooms. Perform microbiological assays, including Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden, and Plate Reading. Enter, review, and trend assay results data. Maintain lab equipment and lab spaces. Support various department projects. Perform additional duties as required. Requirements Vocational Training (MLO level 4) or a bachelor's degree in Microbiology preferred. 0 to 4 years of experience in a Microbiology lab or Environmental Monitoring. Proficient in microbiological techniques like air monitoring, water testing, surface monitoring, and microbial identification. Experience with aseptic techniques and clean room operations. Ability to gown for clean room entry and lift approximately 12 kg. Knowledge of GMP, regulations, and quality control processes. Proficient in MS Word, Excel, and PowerPoint. Excellent interpersonal, verbal, and written communication skills in English (Dutch not required). Comfortable in a fast-paced environment and adaptable to changing priorities. Join us in our client's mission to transform cancer treatment and make a real difference in patients' lives. Apply now to be part of this exciting journey!

The Company A leading global biotechnology organization with a strong focus on innovative manufacturing, advanced automation, quality, and operational excellence. The organization operates in a highly regulated GMP environment and invests in reliable, secure, and sustainable manufacturing technologies. Role Description As a Senior Automation Engineer, you are responsible for the automation aspects of new and upgraded manufacturing equipment across Device Assembly, Inspection, Labeling, and Packaging. You will oversee automation throughout the equipment lifecycle, from design and installation through commissioning, qualification, and operational support, while ensuring reliability, compliance, security, and continuous improvement. Responsibilities - Lead and manage automation activities according to project timelines and requirements. -Support New Product Introduction (NPI) activities and equipment implementation. - Author and review automation design documents, including URS, FDS, HDS, and SDS. - Support FAT, commissioning, testing, and qualification activities at vendors and on-site. - Implement automation hardware, software, and security standards. - Ensure equipment complies with required cybersecurity and monitoring standards. - Participate in Data Integrity Assessments and Automation Preventive Maintenance activities. - Develop backup/restore procedures, work instructions, parameter lists, and audit trail review procedures. - Support PI data historian connections and equipment data integration. - Advise on automation spare parts and develop asset spare-parts lists. - Provide automation training to Maintenance, Engineering, and relevant Operations teams. - Provide on-floor hypercare and troubleshooting support when required. - Monitor project progress and provide updates to Project Management. - Maintain and update documentation required for long-term operational support. Requirements - Bachelor’s or Master’s degree in Automation Engineering, Industrial Information Systems, or a related field. - At least 5 years of automation and process control experience in pharmaceutical or biotechnology manufacturing. - Proven experience with labeling and packaging equipment. - Knowledge of PLC, HMI, SCADA, Industrial PCs, and vision systems such as Cognex. - Strong understanding of GMP and regulated manufacturing environments. - Excellent communication, project management, and problem-solving skills. - Fluent in English and flexible to work outside standard office hours when required. 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 a well-established organization with multiple production locations in the Netherlands. They operate in a dynamic environment where accurate HR administration and strong employee support are essential to daily operations. Job Description: We are looking for a proactive and service-oriented HR Operations Specialist / HR Administrator to support the day-to-day delivery of HR operations. In this role, you will ensure accurate employee administration and support employees and managers in navigating HR processes and systems. You will work closely with HR colleagues and internal stakeholders and contribute to a smooth and professional HR service experience. This position requires you to work on-site at the production location in Oudkarspel and/or Katwijk. Responsibilities: Manage HR administration throughout the employee lifecycle (onboarding, contract changes, transfers, offboarding). Maintain accurate and complete employee data and documentation in HR systems (Workday experience is a strong advantage). Respond to employee and manager queries in a timely, professional, service-oriented manner. Investigate and resolve HR system-related questions and issues, escalating complex matters when required. Prepare employment documents, letters, and other HR correspondence. Support recurring HR operational activities and ensure tasks are completed accurately and on time. Collaborate with HR colleagues, Payroll, and other internal stakeholders to resolve operational matters. Help ensure HR processes and employee records comply with internal policies and applicable requirements. Identify opportunities to improve HR processes, documentation, and the employee experience. Create and maintain process documentation, guidelines, and employee-facing information. Support HR operational projects and system improvements as required. Assist with HR reporting, data checks, and audits. Requirements: 1–2 years of experience in HR Operations, HR Administration, or a similar HR support role. Experience working with an HR information system; Workday is a strong advantage. Good understanding of core employee lifecycle processes. Strong administrative skills and excellent attention to detail. Comfortable investigating problems and finding practical solutions. Able to handle employee information with discretion and confidentiality. Strong written and verbal communication skills in Dutch are required. Good written and verbal communication skills in English. Able to prioritize tasks and work effectively in a fast-paced environment. Comfortable working both independently and collaboratively. Willing and able to work on-site in Oudkarspel and/or Katwijk. 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 leading dairy cooperative with a global presence and a rich 150+ year history. They focus on producing high-quality nutritional ingredients and dairy solutions, and are strongly committed to innovation, sustainability and operational excellence within a highly automated and hygienic production environment. Job Description As an OT Support Engineer, you will support and improve complex automation systems within a highly automated production environment. You will troubleshoot software-related issues, implement corrective changes, coordinate improvement projects, and work closely with Operations, Maintenance, and OT engineers to optimise production and minimise downtime. Key Responsibilities Troubleshoot and resolve software-related issues within production automation systems. Implement corrective actions to fix system errors and improve overall performance. Work on continuous improvement projects to enhance manufacturing efficiency. Collaborate with experienced engineers to execute maintenance tasks and projects. Train and support colleagues in the maintenance team. Maintain standards and documentation related to automation systems. Communicate effectively with operational teams to prioritize and manage ongoing issues and projects. Take responsibility for planning, scheduling, and monitoring your workload and resources, including budget considerations. Requirements HBO level education in Industrial Automation or a related field. At least 1 years of experience in a technical, production environment (preferably process industry). Knowledge of automation systems such as Siemens PCS-7, Wonderware, Simatic IT, or FactoryLink/TI. Fluent in Dutch and English, both spoken and written. A proactive, energetic, and results-oriented mindset, with strong communication and problem-solving skills. Sociable and comfortable expressing opinions, with a mindset that embraces learning from mistakes. Well-organized and able to work structured, with capacity to handle multiple projects simultaneously. Willingness to work on-site with occasional remote work (max. 1 day per week). Other Information Apply to our vacancy for more information. We look forward to hearing from you!

The Company An international food production company specializing in high-quality frozen snacks and convenience products for both retail and foodservice markets. With multiple production sites across Europe, the company focuses on innovation, sustainability, and delivering tasty products that meet the latest consumer trends and quality standards.   Role Description We are looking for a proactive and service-oriented HR Operations Specialist to support daily HR activities, maintain accurate employee records and assist employees and managers with HR processes and systems. You will collaborate with HR, Payroll and other stakeholders to ensure efficient administration and a positive employee experience.   Responsibilities Manage employee lifecycle administration, including onboarding, contract changes, transfers and offboarding. Maintain accurate employee data and documentation in Workday and other HR systems. Respond to employee and manager queries and resolve HR system issues. Prepare employment documents and HR correspondence. Collaborate with HR, Payroll and internal stakeholders to resolve operational matters. Ensure compliance with internal policies and identify opportunities to improve HR processes. Support HR reporting, audits, documentation and system improvement projects.   Requirements 1–2 years of experience in HR Operations, HR Administration or a similar role. Experience with HR information systems; Workday experience is an advantage. Good understanding of employee lifecycle processes. Strong administrative skills and attention to detail. Strong written and verbal Dutch skills and good English skills. Ability to handle confidential information professionally. Strong problem-solving, communication and organizational skills. Able to work independently and collaboratively in a fast-paced environment.   Other information Apply to our vacancy for more information. Looking forward to getting in touch!    

About the Company Our client is a global biopharmaceutical organization developing innovative cell therapies for cancer treatment. The QC Microbiology team works in a GMP environment supporting the quality and safety of advanced therapies. Role Description As a QC Microbiology Analyst, you will perform microbiological testing and environmental monitoring in a controlled GMP environment. You will work as part of a multidisciplinary team and contribute to reliable laboratory operations and quality control. Key Responsibilities Perform environmental monitoring of cleanrooms Perform microbiological assays, including sterility testing and plate reading Enter, review, and trend microbiological data Maintain laboratory equipment and work areas Follow GMP and quality control procedures Support QC Microbiology projects and improvement activities Requirements MLO level 3 or Bachelor's degree in Microbiology 1+ years of microbiology laboratory or environmental monitoring experience Experience with air and surface monitoring Experience with aseptic techniques and cleanroom operations Knowledge of GMP and quality control processes Good English communication skills; Dutch is not required Comfortable working in a fast-paced environment Willing and able to work an 18-week rotating shift schedule

Job Vacancy — Senior Automation Engineer | Breda   About our client Our client is a global biotechnology company developing and manufacturing innovative medicines for patients worldwide. The Breda site is a large-scale manufacturing operation focused on the assembly, inspection, labeling and packaging of pharmaceutical products. The site operates in a highly regulated GMP environment, where reliable equipment, automation and data integrity are essential to maintaining safe, compliant and efficient production.   About the position We are looking for a Senior Automation Engineer to join the Equipment Engineering team in Breda. In this role, you will take ownership of the automation side of new and upgraded manufacturing equipment — from design and vendor testing through installation, qualification and operational handover. You will work closely with Engineering, Manufacturing, Maintenance, IT and external equipment suppliers to make sure automation systems are reliable, secure, compliant and ready for production. This is a hands-on role for someone who enjoys combining automation engineering, project execution and troubleshooting in a regulated manufacturing environment.   Responsibilities Lead the automation activities for new and upgraded manufacturing equipment. Review and develop automation design documentation, including URS, FDS, HDS and SDS. Support FAT, commissioning, testing and qualification activities. Work with PLC, HMI, SCADA, industrial PC and vision systems. Ensure equipment meets required automation, cybersecurity and data integrity standards. Support equipment integration with site systems, including the PI data historian. Develop and maintain backup/restore, parameter and audit-trail procedures. Support automation troubleshooting and provide on-floor hypercare during implementation. Assess preventive maintenance requirements and automation spare parts. Maintain equipment documentation and asset parameter lists. Train Maintenance, Engineering and relevant Operations teams. Report project progress and technical risks to project management. Support New Product Introduction (NPI) activities at the site.   Requirements Bachelor’s or Master’s degree in Automation Engineering, Industrial Automation, Industrial Information Systems or a related discipline. 5+ years of experience with automation/process control and information systems in pharmaceutical or biotechnology manufacturing. Proven experience with labeling and/or packaging equipment. Practical knowledge of PLC, HMI, SCADA, industrial PCs and vision systems such as Cognex. Experience working in a GMP/regulatory manufacturing environment. Experience delivering automation projects in cross-functional or international teams. Strong understanding of equipment implementation, testing and commissioning. Able to troubleshoot technical issues and translate them into practical solutions. Strong communication and stakeholder-management skills. Fluent English, written and spoken.

Company Our client is a global leader in the pharmaceutical industry, operating in a highly regulated GMP environment. They run complex manufacturing and packaging operations and invest continuously in engineering projects that strengthen compliance, reliability, and quality across the site. Job Description Our client is looking for a GMP Validation Engineer to support engineering projects focused on secondary packaging equipment. The role will drive commissioning, qualification, and validation (CQV) activities and ensure solutions are implemented in line with site standards, documentation expectations, and GMP compliance. Responsibilities - Lead and execute commissioning, qualification, and validation activities for packaging-related systems. - Develop, update, and maintain CQV documentation, such as: system criticality assessments, commissioning/qualification/validation plans, risk assessments, test protocols, requirements traceability matrices, CQV summary reports - Define and report test strategies that meet internal customer requirements and standard CQV procedures. - Provide technical guidance to project teams to ensure the implemented solution follows the validation approach and meets required standards. - Coordinate priorities, identify risks, and escalate where needed to keep project phases on track (design, implementation, testing, commissioning, validation). - Support additional tasks or engineering/validation projects as assigned by the supervisor. Requirements - Background in CQV (Commissioning, Qualification, Validation) within pharmaceutical manufacturing (at least 3 years hands-on experience). - Experience with secondary packaging systems, ideally including print & inspection systems (e.g., Systech, Cognex). - Experience with Computerized Systems Validation (CSV). - Strong technical documentation skills and good English technical writing. - Able to work independently with clear communication and strong stakeholder management. - Comfortable working in a GMP environment with strong attention to quality and compliance. Other Information The role is based on-site in Breda, Netherlands, within an engineering organization focused on delivering compliant technical solutions in a structured project environment. If you are interested and want to apply, please submit your application via the apply button below and contact me. Company Our client is a global leader in the pharmaceutical industry, operating in a highly regulated GMP environment. They run complex manufacturing and packaging operations and invest continuously in engineering projects that strengthen compliance, reliability, and quality across the site. Job Description Our client is looking for a GMP Validation Engineer to support engineering projects focused on secondary packaging equipment. The role will drive commissioning, qualification, and validation (CQV) activities and ensure solutions are implemented in line with site standards, documentation expectations, and GMP compliance. Responsibilities - Lead and execute commissioning, qualification, and validation activities for packaging-related systems. - Develop, update, and maintain CQV documentation, such as: system criticality assessments, commissioning/qualification/validation plans, risk assessments, test protocols, requirements traceability matrices, CQV summary reports - Define and report test strategies that meet internal customer requirements and standard CQV procedures. - Provide technical guidance to project teams to ensure the implemented solution follows the validation approach and meets required standards. - Coordinate priorities, identify risks, and escalate where needed to keep project phases on track (design, implementation, testing, commissioning, validation). - Support additional tasks or engineering/validation projects as assigned by the supervisor. Requirements - Background in CQV (Commissioning, Qualification, Validation) within pharmaceutical manufacturing (at least 3 years hands-on experience). - Experience with secondary packaging systems, ideally including print & inspection systems (e.g., Systech, Cognex). - Experience with Computerized Systems Validation (CSV). - Strong technical documentation skills and good English technical writing. - Able to work independently with clear communication and strong stakeholder management. - Comfortable working in a GMP environment with strong attention to quality and compliance. Other Information The role is based on-site in Breda, Netherlands, within an engineering organization focused on delivering compliant technical solutions in a structured project environment. If you are interested and want to apply, please submit your application via the apply button below and contact me.