Facility Maintenance Engineer, Leiden, Zuid-Holland

The Company A leading global biotechnology organization focused on developing and delivering innovative medicines for patients with serious illnesses. Its Breda operation brings together more than 1000 employees representing 38 nationalities across manufacturing, supply chain, commercial activities, and clinical research. About the Role The QA Batch Release Specialist provides Quality Assurance oversight for Investigational Medicinal Products throughout clinical supply chain activities. The position supports batch review for QP certification, clinical labeling, temperature excursion assessments, deviations, SOPs, and quality activities within clinical packaging and labeling operations. The role works closely with Clinical Supply Chain, Warehouse and Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs. Responsibilities - Perform batch review to support QP batch certification of Investigational Medicinal Products according to EU and international requirements - Review and approve clinical label artwork from a compliance perspective - Assess temperature excursions occurring during transportation and at clinical sites - Support resolution of compliance and quality issues associated with clinical product manufacturing and transportation - Review and approve minor deviations and ensure procedural requirements are met - Create and maintain operational SOPs and Work Instructions - Review SOPs against corporate, site, and regulatory requirements Prepare monthly quality metrics - Identify quality issues and collaborate cross functionally on solutions - Provide Quality Assurance support within clinical packaging and labeling operations - Perform packaging checks and batch record reviews - Support issue handling during manufacturing activities - Execute QA compliance checks on the production floor Requirements - Master of Science degree, preferably in Life Sciences or a related discipline - Typically at least 3 years of relevant Quality Assurance or pharmaceutical or medical device manufacturing experience - Experience with batch record review - Experience with investigations and analytical testing - Knowledge of Good Manufacturing Practice - Knowledge of Good Distribution Practice and or Good Clinical Practice - Strong understanding of compliance and quality requirements - Strong communication skills - Fluent English Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

About the Company An international biopharmaceutical organization with a modern manufacturing site in Breda, supplying medicines to patients worldwide. Role Description As Lead Technician Utilities, you will coordinate maintenance activities and support the reliable operation of critical utility systems across manufacturing, warehousing and office facilities. You will combine hands-on technical expertise with team coordination and coaching, while driving equipment reliability, safety and continuous improvement. Key Responsibilities Coordinate and prioritize maintenance across utility systems and facility infrastructure Provide technical guidance and coaching to technicians and contractors Troubleshoot complex utility and facility issues Coordinate with Engineering, Facilities, Operations and external service providers Drive equipment reliability and continuous improvement initiatives Support systems including HVAC, refrigeration, compressed air, chilled water, boilers and building automation Participate in the on-call rotation for critical utility systems Requirements Experience in utilities, facilities, maintenance or industrial installations Strong troubleshooting skills and a hands-on approach Experience coordinating maintenance, contractors, projects or technical teams Strong communication and coaching skills Good command of English Willingness to participate in an on-call rotation GMP experience and knowledge of SAP PM or another CMMS are a plus

Over het bedrijf Een internationale farmaceutische organisatie die innovatieve geneesmiddelen ontwikkelt binnen een sterk gereguleerde GMP-productieomgeving. Functieomschrijving Als Maintenance Engineer ondersteun je de Business System Owner bij het beheer van farmaceutische watersystemen, waaronder WFI/WDI, BMS en EMS. Je zorgt voor de betrouwbaarheid van installaties, GMP-compliance en operationele gereedheid en draagt bij aan onderhoudsstrategieën, investeringsplannen en technische projecten. Belangrijkste verantwoordelijkheden Beheren van clean utility-assets om betrouwbaarheid, beschikbaarheid, kwaliteit en kostenefficiëntie te waarborgen Ondersteunen van langetermijnonderhoudsstrategieën en CAPEX-investeringsplannen Beoordelen en beheren van wijzigingen (MoC) tijdens ontwerp, commissioning en kwalificatie Beoordelen van technische gegevens en de impact van voorgestelde wijzigingen Ondersteunen van engineeringprojecten en zorgen voor een goede overdracht en operationele gereedheid Bewaken van naleving van GMP-, EHS- en interne assetmanagementvereisten Identificeren en implementeren van verbeteringen aan clean utility-systemen Samenwerken met de Business System Owner en de Maintenance- en Engineeringteams Vereisten Minimaal 2 jaar ervaring binnen een farmaceutische/GMP-omgeving Praktische ervaring met WFI/WDI-clean utility-systemen — must-have Ervaring met assetmanagement en onderhoud van farmaceutische utilities Kennis van BMS en besturingssystemen voor clean utilities Kunnen lezen en aanpassen van P&ID's Kennis van GMP, Management of Change, commissioning en kwalificatie Goede communicatieve vaardigheden in het Engels & Nederlands Ervaring met SAP PM of andere CMMS-systemen is een pré Ervaring met CAPEX-planning en investeringsprojecten is een voordeel

Company We are working with a leading industrial organization dedicated to advancing safety, environmental standards, and operational excellence. The company prioritizes sustainable development, innovation, and the well-being of its employees and stakeholders. Job Description We are recruiting for an experienced Industrial Project Manager who will play a key role in managing and delivering complex health, safety, and environmental projects. The successful candidate will oversee projects from inception through to implementation, ensuring alignment with strategic safety goals and legal requirements. This is a dynamic role that involves working closely with multiple teams and external partners to drive improvement initiatives across the organization. Responsibilities - Lead large-scale, multi-disciplinary HSE projects from initial planning to full integration. - Translate strategic safety objectives, legal obligations, and risk considerations into clear project plans and business cases. - Manage project scope, schedules, budgets, quality standards, risks, dependencies, and benefits. - Establish and maintain effective project governance, facilitating timely decision-making with sponsors, management, and steering groups. - Coordinate efforts among operational units, HSE specialists, support departments, and external stakeholders to meet shared goals. - Provide functional leadership to project teams, defining roles and responsibilities, and ensuring accountability. - Communicate progress, challenges, risks, and decisions effectively to all stakeholders. - Ensure that changes are formally handed over to operational teams and embedded into ongoing processes, systems, and management routines. Requirements - HBO or WO degree, preferably in engineering, business administration, safety management, or environmental sciences. - Significant experience in managing complex projects or programs within technical or industrial settings. - Proven track record in transformation, change management, and risk mitigation. - Strong stakeholder management and strategic project governance skills. - Fluent in Dutch and English, with excellent communication skills. - Valid VCA-VOL certification. - Relevant project management certifications are an advantage. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company overview: Our client is a leading pharmaceutical company committed to delivering high-quality products through innovative processes and rigorous standards. They focus on continuous improvement and patient safety, maintaining excellence across all facets of their operations. Job Description: We are seeking a dedicated Facilities Maintenance Specialist with strong expertise in clean utilities systems to ensure the reliable and compliant operation of pharmaceutical water systems (WFI and WDI). The role involves supporting maintenance and engineering efforts related to GMP-compliant utilities critical to the production process. Responsibilities: •    Support the Business System Owner (BSO) for GMP water systems, including WFI and WDI, ensuring optimal system availability and performance. •    Collaborate with maintenance and engineering teams on long-term investment plans and CAPEX projects. •    Present investment proposals during budget planning cycles, incorporating insights from the BSO. •    Assist in managing change processes during design, commissioning, and qualification phases, evaluating impacts and ensuring compliance with GMP standards. •    Support installation and upgrade activities, ensuring reliability, quality, and cost-effectiveness. •    Participate in engineering projects, including system handovers, to guarantee operational readiness and GMP compliance for BMS and EMS systems. •    Ensure adherence to all regulatory and policies regarding manufacturing asset management, EHS, and GMP. Requirements: •    HBO level education or equivalent, preferably with a technical background. •    Minimum of 2 years' experience in a regulated pharmaceutical or GMP environment. •    Proven expertise with GMP systems, WDI/WFI utilities, and control strategies (BMS). •    Skilled in reading and editing P&ID diagrams. •    Strong problem-solving skills and meticulous attention to detail. •    Good communication skills in English. •    Knowledge of SAP PM or similar systems is advantageous. 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 leading organization dedicated to operational and business excellence across highly regulated industries. They are committed to continuous improvement, innovation, and delivering the highest standards in their processes. Job Description: We are seeking an experienced Business Excellence Specialist to support and drive Lean Six Sigma initiatives within their operations. This role involves coaching teams, implementing process improvements, and contributing to the organization’s manufacturing and operational excellence strategies. Responsibilities: - Assist in executing projects and initiatives aimed at improving manufacturing and business processes. - Support the development and documentation of new and existing manufacturing procedures to maximize efficiency and cost-effectiveness. - Conduct simple trend analyses and contribute to continuous improvement efforts. - Collaborate with stakeholders to develop and establish key performance indicators (KPIs) and performance tracking systems. - Provide basic training on Lean principles and tools to team members. - Identify opportunities for process enhancements through observation and data analysis. - Support the implementation of lean tools such as standardized work, work charts, and training matrices. - Drive focused continuous improvement activities aligned with KPIs. - Foster cross-site collaboration to share best practices and ensure consistency. - Promote understanding of Johnson & Johnson’s Credo and Leadership Imperatives in daily activities. Requirements: - At least 3 years of experience in Business or Operational Excellence. - Lean Black Belt certification or equivalent hands-on experience in leading continuous improvement initiatives. - Strong knowledge of Lean Six Sigma tools and methodologies. - Relevant degree (HBO level or similar), with a focus on business or technical disciplines. - Proficiency in English (B2 level). - Intermediate MS Office skills; data analysis and business applications knowledge preferred. - Positive, proactive, and organized attitude. - Ability to work independently and as part of a team. - High attention to detail and a drive for quality. - Strong analytical thinking and problem-solving skills. - Ability to handle changing priorities and work under pressure. - Excellent stakeholder management and communication skills. 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 leading organisation in the life sciences sector, focused on developing innovative therapies and running high-quality clinical research. The team works in a highly regulated environment and partners closely with internal stakeholders and external vendors to deliver trials efficiently, safely, and in full compliance. Job Description We are looking for a Clinical Trial Manager to take ownership of the operational delivery of clinical trials. This person will lead a cross-functional trial team, manage external partners such as CROs, and ensure trials are delivered on time, within budget, and to the required quality and compliance standards. Responsibilities - Lead the trial-specific cross-functional Clinical Management Team, including oversight of CRO partners. - Drive trial delivery to meet agreed timelines, budget, and quality expectations. - Build strong collaboration with internal and external stakeholders to support smooth trial progress. - Support selection of CROs and contribute to defining scope of work and expectations. - Actively manage CRO performance throughout the trial and ensure clear communication and follow-up. - Ensure issues and risks are identified early and escalated appropriately to protect progress and quality. - Support audits and inspections and help drive timely responses when needed. - Maintain and manage trial budgets, including forecasting, accruals, and invoice coordination. - Lead risk management activities related to patient safety and data integrity. Requirements - Bachelor’s degree in a relevant field (Master’s degree preferred). - At least 5+ years of experience in Clinical Operations. - Proven experience leading and managing clinical trials. - Strong experience working with CROs and coordinating trial activities. - Solid understanding of regulated clinical trial delivery and quality expectations (e.g., ICH-GCP and internal SOPs). - Comfortable working with trial documentation and budget monitoring. - Temporary Full-Time Contract (6 Months) Other Information This is a great opportunity for an experienced clinical operations professional who enjoys owning trial delivery and working closely with a wide range of stakeholders. If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company An international life sciences organization focused on developing innovative healthcare solutions. The organization operates in a collaborative, global environment and values quality, inclusion, and the contribution of its people. Role description The Talent Acquisition Manager will support recruitment across European operations while collaborating with an international Talent Acquisition team. The role involves partnering with Hiring Managers and HR Business Partners to attract and recruit talent across multiple functions and seniority levels. This position is responsible for managing the full recruitment lifecycle, providing recruitment advice, and delivering a positive candidate and hiring manager experience. It also contributes to improvements in recruitment processes and broader Talent Acquisition initiatives. This is a temporary position for six months, with a hybrid working model combining office attendance and remote working. An extension is not currently anticipated; any continuation will depend on business needs. Responsibilities Manage the full recruitment lifecycle, including intake meetings, job postings, sourcing, screening, interviewing, offers, and recruitment system administration Partner with Hiring Managers and HR Business Partners to understand business needs and develop effective recruitment strategies Conduct role briefings to agree on candidate profiles, recruitment timelines, and hiring expectations Build and maintain diverse talent pipelines for current and future recruitment needs Proactively identify and engage suitable candidates through multiple sourcing channels Support recruitment for permanent and contract positions, working with external recruitment partners where appropriate Deliver a positive candidate experience through clear communication, timely updates, and effective relationship management Ensure recruitment activities comply with internal policies, applicable local employment regulations, and hiring best practices Provide market insights and recruitment trends to support informed hiring decisions Contribute to recruitment process improvements, employer branding activities, and Talent Acquisition projects Collaborate with international recruitment colleagues to share best practices and support changing hiring volumes Requirements Bachelor's degree Minimum of 2 years of experience in Talent Acquisition, Recruitment, or Human Resources with substantial recruitment responsibilities Recruitment experience within biotechnology, pharmaceuticals, life sciences, or healthcare strongly preferred Experience managing full-cycle recruitment across multiple functions and seniority levels Strong stakeholder management skills, with the ability to advise and influence Hiring Managers Excellent communication and interpersonal skills, with the ability to build trusted relationships in an international environment Strong organizational skills and the ability to manage multiple vacancies and competing priorities A proactive, solution-oriented approach and strong problem-solving abilities High standards of professionalism and discretion when handling confidential information Experience using an Applicant Tracking System; familiarity with enterprise HR systems is an advantage Proficiency with Microsoft 365

Company: A leading organization dedicated to manufacturing and production, committed to operational excellence and continuous improvement. The company values proactive professionals who thrive in a dynamic environment and are focused on optimizing supply chain processes. Job Description: We are seeking a skilled Senior Supply Chain Planner to join our client's team. In this role, you will be responsible for developing and maintaining reliable production schedules, ensuring optimal alignment between demand, capacity, and materials. You will play a key role in enhancing supply chain efficiency by leveraging your expertise in ERP systems and production planning to support the company's growth and operational targets. Responsibilities: - Develop and oversee short-, medium-, and long-term production schedules, balancing capacity, material availability, and customer demand. - Monitor and improve delivery reliability, service levels, and production efficiency. - Identify potential risks and bottlenecks, implementing corrective actions proactively. - Act as the main point of contact and key user for ERP and MRP systems, continuously optimizing these platforms for planning accuracy. - Lead improvements in ERP functionality, including data quality, master data, and planning parameters. - Manage safety stock levels, order quantities, lead times, and capacity settings. - Collaborate with cross-departmental teams to execute technical projects, system upgrades, and compliance initiatives. - Analyze supply chain and production data to identify performance gaps and drive continuous improvements. - Implement best practices in Sales & Operations Planning (S&OP), inventory management, and capacity planning. - Support operational excellence and lean initiatives by leading process improvements. - Prepare reports and KPIs to support management decision-making. Requirements: - Higher professional education (HBO level) in a relevant field. - At least 5 years of experience in production, supply chain, or operations planning. - Strong knowledge of ERP systems such as SAP, Microsoft Dynamics, Oracle, or similar platforms. - Experience with MRP systems and production processes. - Demonstrable experience with ERP implementations or system optimizations. - Strong analytical skills and data-driven mindset. - Knowledge of process improvement and change management. - Proactive, results-oriented approach. - Fluency in Dutch and English. - Certifications such as Lean Green Belt or APICS CPIM are advantageous. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company A leading food manufacturer specializing in frozen snacks and appetizers for customers across various markets. The organization focuses on delivering high-quality products while maintaining strict food safety standards, operational efficiency, and continuous improvement. It offers a dynamic production environment with opportunities for professional growth and collaboration across teams. Role Description As a Senior Production Planner, you are responsible for aligning production plans with customer demand, capacity, and material availability. You optimize ERP and MRP systems, improve planning processes, and drive operational efficiency through data analysis and continuous improvement. Working closely with Supply Chain, Production, Operations, and IT, you ensure reliable deliveries and optimal inventory levels. Responsibilities - Develop and monitor short-, medium-, and long-term production plans, ensuring alignment between demand, capacity, and material availability. - Optimize delivery performance, production efficiency, and inventory levels while identifying and resolving planning bottlenecks. - Act as the key user for ERP and MRP systems, improving system functionality, planning parameters, and master data accuracy. - Support ERP implementations, upgrades, and optimization projects, including training and guiding end users. - Analyze production and supply chain performance, develop KPI reports, and identify opportunities for process improvement. - Lead initiatives focused on Lean, Operational Excellence, capacity planning, and inventory management. - Collaborate with Supply Chain, Production, Operations, and IT to implement process improvements and support change management. Requirements - HBO-level education or equivalent. - Minimum of 5 years of experience in production planning, supply chain planning, or operations planning. - Demonstrable experience with ERP implementations, system optimization, or improvement projects. - Strong knowledge of MRP principles, production processes, and planning parameters. - Experience with ERP systems such as CSB, SAP, Microsoft Dynamics, Oracle, or similar platforms. - Strong analytical skills, data-driven decision-making capabilities, and experience with KPI reporting. - Experience in continuous improvement, process optimization, and change management. - Proactive, results-oriented, and capable of working effectively with cross-functional teams. - Good command of both Dutch and English. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.