Validation Engineer, Hoofddorp, Noord-Holland

The Company A global pharmaceutical manufacturing organization focused on innovation, quality, and operational excellence. The company operates highly automated production facilities within a GMP regulated environment and invests heavily in advanced manufacturing technologies and continuous improvement initiatives. Role Description As an Automation Operator, you will be responsible for operating, monitoring, and optimizing automated production lines to ensure safe, efficient, and compliant manufacturing processes. This role combines technical troubleshooting, equipment operation, and GMP documentation while supporting process improvements and production performance. Responsibilities - Operate and monitor automated production equipment according to SOPs and GMP standards - Perform troubleshooting and root cause analysis on automated systems - Adjust machine parameters and settings to improve operational performance - Record and verify production data within SAP and MES systems - Monitor process performance and report deviations when required - Complete batch records, production logs, and GMP documentation accurately - Participate in cross functional problem solving and triage meetings - Execute equipment startup and shutdown procedures - Perform routine cleaning activities according to production schedules - Identify and support continuous improvement opportunities - Contribute to Lean Manufacturing initiatives - Ensure smooth shift handovers and effective communication - Maintain a safe and compliant production environment Requirements - Minimum 3 years of experience in a similar manufacturing or production role - Experience working within automated production environments - Fluent English communication skills - Experience following SOPs and GMP procedures - Knowledge of assembly and packaging processes - Experience using SAP and MES systems - Strong troubleshooting and analytical skills - Experience with Lean Manufacturing and Six Sigma principles - Technical understanding of mechatronics, pneumatics, and electronics - Ability to understand and explain the function of sensors, valves, bearings, and automation components - Willingness to work in rotating 3-shift or 5-shift schedules. - Technical education such as MBO, VAPRO B, or equivalent Other Information - Shift based work environment - Pharmaceutical manufacturing environment - GMP regulated facility - Strong focus on automation, quality, and continuous improvement

Company Our client is an international life sciences organisation operating in a highly regulated environment. They develop and manufacture innovative therapies and are committed to high standards in quality, compliance, and continuous improvement. The working environment is dynamic, fast-paced, and strongly focused on teamwork and operational excellence. Job Description For a manufacturing site in Hoofddorp, we are looking for a GMP Cell Therapy Production Specialist to support the production of clinical and commercial cell therapy products in a cleanroom setting. This role sits within either the production team or the production support team and is focused on safe, compliant execution of manufacturing activities, accurate documentation, and proactive support of process improvements. Responsibilities The GMP Cell Therapy Production Specialist will be responsible for: - Executing manufacturing and/or production support activities in a GMP-regulated cleanroom environment (including aseptic areas). - Following SOPs and cGMP requirements and completing batch records accurately and on time. - Performing activities such as material preparation, material decontamination, and transferring materials and documentation into cleanroom areas. - Supporting aseptic processing steps and ensuring consistent process execution to meet quality standards. - Performing visual inspection activities and supporting cryopreservation activities when required. - Handling sample submission and coordination with Quality Control / sample management. - Supporting deviation investigations and contributing to change management activities. - Troubleshooting basic processing and equipment issues and escalating where needed. - Identifying opportunities for continuous improvement and supporting implementation of efficiency and quality improvements. - Working closely with cross-functional teams such as Production Support, Material Management, QA, and QC. Requirements - Education at MBO/MLO/HBO level (Level 4+) in Life Sciences or a related discipline. - Proven experience working in a GMP-regulated pharmaceutical, biotechnology, or similar manufacturing environment. - Comfortable working in full gowning requirements in an aseptic cleanroom environment. - Strong attention to detail and confidence with documentation and batch record execution. - Good skills in Microsoft Word and Excel; comfortable working with data. - Strong communication skills in English (Dutch is not required). - A hands-on mindset, willingness to learn, and the ability to adapt in a changing environment. - Willingness to work in a shift schedule (including weekends). - Vapro A/B or LITOP A/B is a plus. Other Information This role requires working in a cleanroom environment and following strict procedures at all times. Because the work involves blood products, vaccination against Hepatitis B is strongly recommended (candidates should already be vaccinated or be willing to get vaccinated). If you are interested and want to apply, please submit your application via the apply button below and contact me.  

The Company A leading organization in the biotechnology and advanced cell therapy sector focused on developing and manufacturing innovative treatments. The company operates in a highly regulated GMP environment with a strong emphasis on quality, patient safety, process excellence, and continuous improvement. Role Description This position supports the manufacturing of clinical and commercial cell therapy products within a GMP regulated environment. Successful candidates will be assigned to either the Production Team or Production Support Team after completing initial training requirements. The role requires hands on manufacturing activities, strict adherence to SOPs and GMP standards, and close collaboration with multiple operational and quality functions. Responsibilities - Perform apheresis accession and transfer to manufacturing areas - Complete batch records according to SOPs and GMP requirements - Support batch documentation review for product release activities - Supply manufacturing suites with required materials and components - Transfer batch records and documentation into cleanroom environments - Conduct final product visual inspections - Perform cryopreservation of excess cells and final product - Submit manufacturing samples to Quality Control - Manufacture clinical and commercial products in Grade A and Grade B cleanroom environments - Complete manufacturing batch records accurately and compliantly - Draft and revise batch records, SOPs, and work instructions - Support deviation investigations and corrective actions - Participate in change management implementation - Troubleshoot processing and equipment related issues - Collaborate with Production Support, Product Sciences, Materials Management, Quality Assurance, and Quality Control teams Requirements - MLO, MBO, or HBO qualification with a Life Sciences background - Experience working within a pharmaceutical, biotechnology, or related manufacturing environment - Proven knowledge of biotechnology or pharmaceutical manufacturing processes - Strong understanding of cGMP regulations and compliance requirements - Experience working within controlled cleanroom environments - Ability to work aseptically and follow strict gowning procedures - Strong troubleshooting and problem solving abilities 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.   Job Description As a Manufacturing Operations Specialist, 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 leader in immunotherapy and engineered T cell therapy, driving innovation in cancer treatment. They are transforming the landscape with personalized, patient-specific therapies. Role Description As a QC Microbiology Analyst, you'll be part of a diverse team of 20+ Analysts, Senior Analysts, and Lead Analysts, reporting to one of the Team Leads in QC Microbiology. Your role involves performing various microbiological assays, environmental monitoring of cleanrooms, data entry and review, and supporting department projects in a fast-paced, collaborative work environment. Knowledge of GMP, aseptic techniques, and microbiological processes are essential for success. Responsibilities - Perform environmental monitoring of cleanrooms.  - Conduct microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden, and Plate Reading.  - Data entry, review, and trending of assay results.  - Perform routine maintenance of lab equipment and lab spaces.  - Support department projects.  Requirements - MLO level 4 (Vocational Training) or a Bachelor's degree in Microbiology preferred.  - 0 to 4 years of Microbiology lab/Environmental Monitoring experience.  - Experience with microbiological techniques such as air monitoring, water testing, surface monitoring, and genus/species identification of microorganisms.  - Knowledge of aseptic techniques and clean room operations.  - Ability to gown for clean room entry and lift approximately 12Kg.  - Familiarity with GMP regulations and quality control processes.  - Proficiency in MS Word, Excel, PowerPoint, and other applications.  Other Information Apply to our vacancy for more. Looking forward to chatting with you!  

The Company  A leading global biotechnology organization, dedicated to developing and delivering innovative medicines to improve patient outcomes. Operating worldwide, the company combines science, technology, and quality-driven processes to ensure safe and effective clinical products.   Role Description We are seeking a skilled Automated Production Systems Technician to support the operation and optimization of advanced, automated manufacturing lines. The role involves ensuring production runs smoothly, adhering to GMP standards, and contributing to process improvements within a regulated environment. Responsibilities -Operate and oversee automated production equipment following SOPs and GMP requirements. -Troubleshoot issues and conduct root cause analysis to resolve technical problems. -Adjust mechanical and process parameters to maximize machine performance. -Record, verify, and manage production data in SAP/MES systems accurately. -Monitor process performance, identify deviations, and escalate when necessary. -Prepare accurate GMP documentation, including batch records and logs. -Participate in problem solving sessions with QA, Engineering, and Production teams. -Carry out equipment setup and shutdown procedures. Requirements -Minimum of 3 years’ experience in a similar production or manufacturing role, ideally in assembly and packaging. -Proven experience working with automated production systems. Fluency in English. -Comfortable working in a structured environment with strict procedures. -Willingness to work in shifts and commute as required. -Ability to participate in triage and problem-solving sessions involving QA, Maintenance, and Production. -Capable of documenting activities following GMP standards. 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 global, innovation-driven organisation in the life sciences sector. They operate in a highly regulated environment and support international clinical programs by ensuring products are prepared, labelled, and packaged accurately and safely for use worldwide. Quality, compliance, and teamwork are central to how the teams work every day. Job Description For our client in Breda, we are looking for a Packaging Operator (GMP) to support clinical labelling and packaging activities. In this role, the Clinical Packaging Operator (GMP) works in a day-shift team and carries out manual labelling, packaging, and assembly activities according to standard operating procedures. The work requires strong attention to detail, clear communication, and a quality-first mindset. Responsibilities - Execute clinical labelling and packaging activities according to standard operating procedures (SOPs) - Perform manual packaging, labelling, and assembly activities accurately and efficiently - Take ownership of tasks and results within the assigned area of responsibility - Escalate deviations, issues, or unexpected situations when necessary - Complete all required training according to the training plan and deadlines - Support batch-related logistics processes linked to packaging activities - Contribute to improvements in working processes, quality, and efficiency - Work in both room temperature areas and, when needed, in cold-room conditions (2–8°C) Requirements - Experience in a manual packaging environment (preferably within a regulated setting such as GMP/GDP) - Comfortable working according to procedures in a strongly regulated environment - Strong attention to detail; accurate and quality-focused way of working - Team player with clear communication skills and a flexible attitude - Willing and able to work on-site in Breda and adapt to changing priorities - Experience with SAP and/or MES is a plus Other Information The Clinical Packaging Operator (GMP) will join a dedicated team supporting important clinical activities in an international environment. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company A leading organization in the pharmaceutical manufacturing sector, committed to producing high-quality, safe medicinal products in a regulated environment. They prioritize continuous improvement, technological innovation, and a collaborative team culture to serve patients effectively. Job Description We are seeking a proactive and detail-oriented Quality Assurance Specialist to join the Plant QA team. This role involves providing essential quality oversight during packaging and labeling operations, supporting compliance initiatives, and ensuring documentation accuracy to meet GMP standards. Responsibilities - Conduct final quality checks on labeling and packaging processes before product release. - Review batch records to verify data accuracy, completeness, and compliance with procedures. - Handle quality issues by investigating deviations, documenting findings, and following up on corrective actions. - Collaborate closely with Production, Maintenance, and QA colleagues, providing guidance and escalation when necessary to halt production if quality concerns arise. - Maintain clear deviation documentation and support corrective and preventive actions. - Participate in ongoing GMP compliance activities, including GMP training, incident investigations, and quality improvement projects. - Review and approve operational SOPs and work instructions as needed. - Prepare and analyze weekly and monthly QA metrics and maintain departmental performance boards. - Act as a key point of contact for production-related quality queries and support cross-departmental cooperation. Requirements - MBO or BSc degree in Pharmaceutical, Life Sciences, or a related field, or equivalent experience. - Approximately 3 years of QA or manufacturing experience within the pharmaceutical or medical device sectors, with a focus on batch record review and investigations. - Strong knowledge of GMP, GDP, and/or GCP regulations, and experience applying them in routine activities. - Excellent attention to detail and technical knowledge in manufacturing and quality processes. - Fluent in English, with good communication and collaboration skills. - Resilience under pressure and assertiveness to address quality concerns confidently. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me. This role involves working on a 3-shift schedule: early, late, and night shifts, with a fixed schedule for each week. 

Het Bedrijf Onze opdrachtgever is een toonaangevende internationale zuivelcoöperatie met meer dan 150 jaar ervaring. De organisatie richt zich op de productie van hoogwaardige zuivelproducten en voedingsingrediënten en zet sterk in op innovatie, duurzaamheid en operationele excellentie binnen een moderne, geautomatiseerde en hygiënische productieomgeving. Functieomschrijving Als Commercial Operations Specialist ben je verantwoordelijk voor het optimaliseren en automatiseren van commerciële processen op het gebied van pricing, masterdata en sales operations. Je werkt nauw samen met verschillende teams en maakt gebruik van SAP, Power BI, Power Query, Power Automate en andere Microsoft-tools om processen te verbeteren, de datakwaliteit te verhogen en continue verbeteringen te realiseren. Verantwoordelijkheden Analyseren, optimaliseren en automatiseren van commerciële processen binnen Pricing, Masterdata en Sales Operations. Ontwikkelen en implementeren van slimme automatiseringsoplossingen met SAP, Power BI, Power Query, Power Automate en andere Microsoft-tools. Verbeteren van de kwaliteit en betrouwbaarheid van prijsgegevens, masterdata en commerciële processen. Signaleren van knelpunten, uitvoeren van procesanalyses en realiseren van duurzame procesverbeteringen. Samenwerken met verschillende interne stakeholders om efficiëntere werkwijzen en datagedreven oplossingen te ontwikkelen. Documenteren en standaardiseren van processen om de continuïteit en kennisborging binnen de organisatie te versterken. Functie-eisen Afgeronde hbo- of wo-opleiding, bij voorkeur in Bedrijfskunde, Supply Chain, Data Analytics of een vergelijkbare richting. Minimaal 5 jaar ervaring binnen Commercial Operations, Sales Operations, Process Improvement of Continuous Improvement. Uitgebreide ervaring met SAP en sterke kennis van commerciële processen, pricing en masterdata. Gevorderde kennis van Excel, Power Query, Power BI, Power Automate en Microsoft Copilot; ervaring met Databricks is een pré. Analytisch, zelfstandig en hands-on, met het vermogen om processen snel te doorgronden en praktische verbeteringen te realiseren. Uitstekende beheersing van de Nederlandse taal; ervaring binnen een FMCG-omgeving is een sterke pré. Overige informatie Solliciteer vandaag nog voor meer informatie over deze vacature. We kijken uit naar je sollicitatie!

Company A leading player within the consumer dairy industry, the company is committed to enhancing its commercial operations through innovative process improvements and digital automation. Their focus is on delivering high-quality products and services by continuously refining their internal processes to stay competitive and efficient. Job Description We are seeking a highly skilled Commercial Process Improvement Specialist to join our client's team on a project basis. This role centers around analyzing, optimizing, and automating key commercial processes to increase efficiency, reduce manual work, and improve data quality. The successful candidate will be instrumental in implementing solutions that support the company's strategic commercial objectives. Responsibilities - Analyze current commercial operations to identify opportunities for process improvements and automation. - Develop and implement automation solutions using existing tools such as Microsoft Power BI, Power Automate, and Databricks. - Streamline pricing processes, including managing price lists, maintaining data accuracy, and automating updates and distribution. - Support master data management and ensure the quality of commercial data across various systems. - Collaborate with team members to create standardized, simplified workflows and document procedures. - Assist with claims, rebate, and commercial condition processes, ensuring data integrity. - Actively contribute to continuous improvement initiatives by implementing pragmatic solutions and automations. - Take a hands-on approach to problem-solving, working independently to deliver measurable results within the project timeline. Requirements - Minimum HBO level education, preferably with a completed Master’s degree. - 5+ years of professional experience in process improvement, automation, or related roles within FMCG or similar sectors. - Deep knowledge of SAP along with strong expertise in Excel, Power Query, Power Automate, and Microsoft Copilot. - Proven track record of automating commercial processes, especially pricing and master data management. - Excellent analytical skills, with the ability to quickly understand complex processes and systems. - Fluent in Dutch; English skills are a plus. - Capable of working independently and efficiently with minimal supervision. - Experience with Lean Six Sigma (Orange Belt) or Agile methodologies is a plus. Other Information This position is a 9-month project with potential for a 3-month extension. The role requires immediate availability, ideally starting as soon as possible, no later than 14-15 September, to ensure a smooth handover. The role involves 38 hours per week, with a hybrid working setup—primarily working from home, with some on-site collaboration at the office on Mondays and Thursdays. The role focuses on process optimization, automation, and continuous improvement rather than team management. The candidate should be a quick learner, proactive problem solver, and capable of independently building solutions that improve workflows and data handling. Two round of in-person interviews will be held, with some flexibility around scheduling. If you are interested and want to apply, please submit your application via the apply button below and contact me.