Senior Specialist Quality Systems, Hoofddorp, Noord-Holland

The company A leading international biopharmaceutical organisation focused on developing innovative therapies and advanced treatments for serious diseases. The organisation operates in a highly regulated environment where quality, scientific excellence, and patient safety are at the centre of its operations. Role Description As a QC Microbiology Analyst, you will join a professional Quality Control Microbiology team supporting laboratory testing and environmental monitoring within a highly regulated GMP environment. You will be responsible for performing microbiological testing, environmental monitoring, laboratory activities, and accurate documentation of analytical results. You will also contribute to data trending, equipment and laboratory maintenance, and departmental improvement projects. This is an excellent opportunity for a motivated microbiology professional who enjoys working in a fast-paced environment and wants to develop their experience within a biopharmaceutical setting. Responsibilities - Perform environmental monitoring of cleanrooms in accordance with approved procedures. - Perform microbiological assays, including sterility testing and plate reading. - Perform air and surface monitoring activities. - Accurately enter, review, and trend microbiological assay results and laboratory data. - Maintain accurate laboratory documentation in accordance with GMP requirements. - Perform routine maintenance of laboratory equipment and laboratory areas. - Follow applicable SOPs, GMP requirements, safety procedures, and quality standards. - Support departmental projects and continuous improvement initiatives. - Work collaboratively with Analysts, Senior Analysts, Lead Analysts, and other QC teams. - Support additional laboratory and departmental activities as required. Requirement - MLO level 3 or Bachelor's degree in Microbiology or a related scientific discipline. - 0–4 years of experience in microbiology laboratory activities and/or environmental monitoring. - Practical experience with microbiological techniques such as air monitoring and surface monitoring. - Experience with aseptic techniques and cleanroom operations. - Knowledge of GMP, regulatory requirements, and Quality Control processes. - Comfortable working in cleanroom environments and following gowning procedures. - Physically able to work in cleanroom and supporting areas, including lifting approximately 12 kg. - Good working knowledge of MS Word, Excel, PowerPoint, and other relevant applications. - Strong interpersonal, verbal, and written communication skills in English. - Able to work effectively in a collaborative and fast-paced environment. - Flexible and able to adapt priorities according to changing operational requirements. Other information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Over het Bedrijf Deze internationale producent binnen de voedingsmiddelenindustrie beschikt over een belangrijke productielocatie in Nederland waar hoogwaardige zuivelproducten worden geproduceerd voor de wereldwijde markt. Veiligheid, duurzaamheid en continue verbetering staan centraal binnen de organisatie, waarbij de HSE-afdeling een essentiële bijdrage levert aan een veilige en gezonde werkomgeving. Rolomschrijving Als HSE Specialist ben je verantwoordelijk voor het verbeteren en waarborgen van de prestaties op het gebied van Health, Safety & Environment binnen de productielocatie. Je werkt nauw samen met productie, management en externe instanties om een sterke veiligheidscultuur te creëren, wet- en regelgeving na te leven en structurele verbeteringen door te voeren. Het is een zelfstandige functie waarbij je zowel zichtbaar bent op de werkvloer als verantwoordelijk bent voor beleidsmatige en administratieve werkzaamheden. Belangrijkste Verantwoordelijkheden Adviseren en ondersteunen van productie en management op het gebied van HSE Initiëren en begeleiden van veiligheids- en milieuverbeteringen Uitvoeren en begeleiden van risicoanalyses, incidentonderzoeken en opvolgacties Bewaken van naleving van HSE-wetgeving, vergunningen en managementsystemen Beheren van het bedrijfsnoodplan en coördineren van de BHV-organisatie Ondersteunen bij audits, inspecties en continuous improvement initiatieven Monitoren en rapporteren van HSE-KPI's en milieuprestaties Samenwerken met interne stakeholders en externe toezichthouders Coachen en motiveren van medewerkers op het gebied van veilig werken Vereisten HBO- of WO-opleiding met ruime ervaring binnen Health, Safety & Environment Aantoonbare ervaring met zowel Veiligheid als Milieu (beide zijn vereist) Kennis van HSE-managementsystemen, risicoanalyses en auditprincipes Ervaring binnen een productie-, food- of industriële omgeving Sterke communicatieve en stakeholdermanagementvaardigheden Zelfstandig kunnen werken in een complexe organisatie Analytisch, gestructureerd en kwaliteitsgericht Natuurlijk leiderschap en het vermogen anderen mee te nemen in veranderingen Vloeiend Nederlands; Engels is een pré

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.

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 Senior Quality Systems Specialist, you are responsible for governing and improving key GMP Quality Systems, ensuring processes remain compliant, robust, and inspection-ready. You will work closely with Quality, Operations, and cross-functional stakeholders at site and cross-site level. Responsibilities - Manage and support Quality Systems including Change Control, Deviations, CAPA, and MRB. - Maintain and improve quality procedures and coordinate site training. - Monitor compliance, quality metrics, and management review inputs. - Identify and manage quality risks in line with EU GMP, ICH Q10, and internal policies. - Chair or support multidisciplinary quality boards and committees. - Support audits and regulatory inspections, including preparation and follow-up. - Review and approve quality documentation, changes, deviations, and CAPAs. - Drive continuous improvement of quality processes, reporting, and automation. - Provide backup support to the Quality Systems Lead/Manager when required. Requirements - 5+ years of Quality Assurance experience within a GMP environment. - Strong knowledge of GMP, EU GMP, and ICH Q10 requirements. - Proven experience with Change Control, Deviations, CAPA, and MRB processes. - Experience in Drug Substance and/or Drug Product environments. - Strong communication, stakeholder management, and organizational skills. - Pragmatic and structured approach to quality and compliance. - Knowledge of aseptic manufacturing and/or ATMP environments is an advantage. - ASQ, Lean Six Sigma, or similar certification is a plus. - Familiarity with Power BI, Power Automate, Smartsheet, and MS Office is desirable. 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.

Company: A leading organization dedicated to advancing healthcare through innovative and quality-driven solutions. Their mission is to support the development and manufacturing of life-saving therapies, focusing on improving patient outcomes worldwide. Job Description: The Quality Systems Specialist plays a vital role in supporting the deployment and management of the company’s quality systems. This position involves ensuring compliance, facilitating cross-site collaboration, and maintaining high standards in quality assurance activities related to regulated pharmaceutical processes. Responsibilities: -Oversee the maintenance, training, and continuous improvement of core quality systems such as Change Control, Deviations, CAPA management, and Material Review Board processes. -Support site and cross-site compliance with regulatory requirements and quality policies. -Facilitate training sessions and act as a backup chair for the EU Change Control Review Board, Deviations, and Material Review Board. -Assist in regulatory inspections and audits, ensuring proper documentation and adherence to cGMP standards. -Manage the review and approval of changes, deviations, CAPA records, and related documentation. -Track and report metrics to identify opportunities for process improvements and support management reviews. -Support multidisciplinary teams in startup activities and process improvements. -Maintain the company’s Quality Management System and ensure timely approval of documents. -Act as a backup support for the Senior Manager of Quality Systems and contribute to ongoing quality initiatives. -Perform other related duties as required to uphold quality standards. Requirements: -At least 5 years of GMP Quality Assurance experience in a pharmaceutical environment (Drug Substance or Drug Product). -Strong knowledge of GMP regulations, ICHQ10 standards, and relevant pharmaceutical law. -Hands-on experience with Change Control, CAPA, Deviations, Internal Audits, and Material Review Boards. -Knowledge of aseptic manufacturing processes. -Proficiency in MS Word, Excel, PowerPoint, Smartsheet, Power BI, Power Automate, and quality management systems. -A bachelor’s degree in technical fields such as Chemistry, Microbiology, Engineering, or similar. -Preferred: Certifications such as ASQ, Black Belt/Green Belt, and experience with ATMPs. 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!