Senior Quality Engineering, Leiden, Zuid-Holland

Company We are looking for candidates for a site engineering team supporting pharmaceutical technical projects within a regulated GMP environment. Job Description This role is for a CQV Commissioning Qualification Validation Engineer (GMP). The engineer will support technical projects with minimal supervision and report to the Senior Manager Validation & Compliance. You will take a hands-on approach to commissioning and qualification activities, develop and execute test strategies, and drive the creation of system commissioning qualification and validation documentation. Responsibilities - Develop and update validation documentation, including system-level criticality assessments, validation and commissioning/qualification plans, risk assessments, test protocols, and requirement traceability matrices - Prepare and maintain commissioning, qualification, and validation summary reports - Lead commissioning, qualification, and validation activities for technical solutions - Provide technical guidance to project teams to ensure implemented solutions follow the validation plan and meet internal customer requirements - Support delivery in line with established site procedures (SOPs) - Carry out additional tasks or projects as requested by your supervisor Requirements - At least 3 years of experience executing commissioning, qualification, and validation within pharmaceutical manufacturing - Hands-on commissioning and qualification experience in secondary packaging operations - Experience with secondary packaging systems, including print and inspection systems (e.g. Systech, Cognex) - Experience in Computerized Systems Validation - Strong understanding of how single documents fit into the broader validation picture - Ability to work with internal and/or external reporting relationships 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 A leading global biotechnology organization focused on developing and manufacturing innovative medicines for patients worldwide. Operating in a highly regulated GMP environment, the company continuously invests in advanced manufacturing technologies, engineering projects, and operational excellence to support its growing product portfolio. Role Description We are looking for a CQV Engineer to support commissioning, qualification, and validation activities within a GMP manufacturing environment. In this role, you will be responsible for developing validation documentation, leading testing activities, and ensuring that new and modified systems are implemented in compliance with internal quality standards and regulatory requirements. The position requires a hands-on validation professional with experience in secondary packaging systems and computerized systems validation. Key Responsibilities Develop and maintain CQV documentation, including plans, protocols, risk assessments, and summary reports. Lead commissioning, qualification, and validation activities for manufacturing systems. Support the implementation of technical solutions in accordance with validation requirements. Perform system risk assessments and requirement traceability activities. Execute and document testing activities within GMP environments. Provide validation guidance to project teams and stakeholders. Ensure compliance with internal procedures and regulatory requirements. Support project delivery from implementation through validation and handover. Requirements Bachelor's degree in Engineering or a related technical discipline. Minimum 3 years of experience in Commissioning, Qualification, and Validation within the pharmaceutical industry. Hands-on experience with secondary packaging equipment and processes. Experience with print and inspection systems such as Systech and Cognex. Strong knowledge of Computerized Systems Validation (CSV). Experience working within GMP-regulated environments. Strong technical writing and documentation skills. Excellent communication, problem-solving, and stakeholder management abilities.

The Company The client is a French multinational that has an R&D-driven presence in the Netherlands, focusing on the research, development, and manufacturing of pharmaceutical products and vaccines, including treatments for oncology, cardiology, and rare diseases.  Role Description A global healthcare leader is seeking a Pharmacovigilance Associate to join its team in the Netherlands. This role focuses on ensuring patient safety through the effective management and evaluation of pharmacovigilance (PV) data. Operating within a diverse and cross-functional environment, you will contribute to safeguarding public health while gaining exposure to a broad product portfolio across multiple therapeutic areas. As part of the North Europe Multi-Country Organization, you will collaborate closely with regional and local teams, supporting pharmacovigilance activities in compliance with local regulations and internal policies. The position also plays a key role in maintaining strong relationships with stakeholders and promoting awareness of PV requirements across the business. Responsibilities Managing personal workload effectively, ensuring timely delivery of pharmacovigilance activities. Handling and process Individual Case Safety Reports in line with regulatory requirements and company procedures. Conducting case assessments and ensuring accurate data entry and reporting. Monitoring and managing PV inbox communications. Following up with reporters (patients, healthcare professionals, vendors) to obtain additional safety information. Identifying and escalating potential safety, quality, or regulatory concerns promptly. Supporting safety surveillance activities, including trend and signal detection (clusters, patterns, variances). Providing relevant safety information to health authorities, internal stakeholders, and external partners. Contributing to risk management activities, including product alerts and patient support programs. Maintaining and updating local and regional quality documentation. Ensuring compliance with pharmacovigilance regulations, corporate policies, and HSE standards. Supporting educational material management and PV-related compliance activities. Delivering pharmacovigilance training to internal teams and external stakeholders. Collaborating with third-party vendors and cross-functional teams within the organization. Requirements Bachelor’s or Master’s degree in Life Sciences (e.g., Pharmacy, Medicine, Biomedical Sciences or equivalent). Previous experience in the pharmaceutical industry, preferably in pharmacovigilance or related areas. Strong understanding of pharmacovigilance processes and regulatory requirements. Fluency in English (C1 level); knowledge of Dutch is an advantage. Strong organizational skills with the ability to prioritize and manage workload independently. High level of accuracy and attention to detail. Excellent communication skills, with the ability to interact with healthcare professionals, patients, and colleagues. Strong interpersonal skills and a collaborative, team-oriented mindset. Ability to handle sensitive information with discretion and confidentiality. Other Information Apply to our vacancy for more information. Looking forward to getting in touch! 

Company: A global food and nutrition organization with strong roots in dairy production, focused on delivering high-quality products through innovation, sustainability and operational excellence. The company operates across multiple international markets with complex supply chain networks. Job Description: This is a high-impact interim procurement role focused on capital expenditure projects across a regional European scope. The position requires taking full ownership of multiple sourcing initiatives, ensuring timely delivery, cost efficiency and adherence to quality standards. You will be driving tender processes, negotiations and supplier engagement while operating in a fast-paced, high-pressure environment. Responsibilities: - Lead and execute CapEx sourcing projects and supplier negotiations across multiple ongoing initiatives - Prepare and manage RFQ processes, evaluate proposals and finalize procurement contracts - Ensure project delivery within timelines, budget and quality requirements - Manage multiple stakeholders, suppliers and projects simultaneously while maintaining clear priorities - Drive compliance with procurement policies, processes and contract standards - Support and implement regional sourcing strategies and align with global category teams - Identify risks, cost-saving opportunities and potential bottlenecks in projects - Strengthen relationships with suppliers and internal stakeholders across functions - Maintain visibility of upcoming and ongoing CapEx project pipelines Requirements: - University degree in procurement, engineering, supply chain or business-related field - Minimum 10 years of procurement experience in an international or industrial environment - Proven expertise in CapEx procurement and project buying - Strong experience managing multiple high-value tenders and negotiations - Ability to quickly ramp up and deliver results with minimal onboarding - Strong analytical skills including business case evaluation and TCO analysis - Ability to prioritize and perform under pressure in a high workload environment - Highly organized, decisive and results-driven - Fluent in English, additional European languages preferred - Strong stakeholder management and communication skills in a matrix organization Other Information: Interim contract for 6 months starting 1 August Hybrid work setup with required presence in Amersfoort and site visits Experience in food or FMCG sector preferred, ideally within dairy If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company The client is one of the Netherlands’ biggest dairy products manufacturers who is also active globally.    Role Description We are seeking an O2C Customer Service Specialist to join a leading multinational in the dairy industry based in Amersfoort. In this role, you will act as a key point of contact for customers, ensuring the smooth execution of the entire order-to-cash cycle. You will work cross-functionally with internal stakeholders to deliver high-quality service, maintain strong client relationships, and support operational excellence within the commercial function. Responsibilities  Managing the end-to-end order-to-cash process, including order entry, order validation, and invoicing. Serving as the primary contact for customer inquiries related to orders, deliveries, and account status. Ensuring accurate and timely processing of customer orders in line with company policies. Collaborating with supply chain, logistics, and finance teams to resolve order or billing issues. Monitoring order fulfillment and proactively communicating delays or discrepancies to customers. Handling customer complaints professionally and driving timely resolution. Maintaining and updating customer data in internal systems to ensure accuracy. Supporting continuous improvement initiatives within the O2C process to optimize efficiency and service quality. Ensuring compliance with internal controls, procedures, and relevant regulations. Requirements Proven experience in a customer service or order-to-cash role, preferably within a multinational or FMCG environment. Strong understanding of end-to-end O2C processes (order management, billing, collections awareness). Excellent communication and stakeholder management skills. High attention to detail and accuracy in administrative tasks. Ability to work in a fast-paced, dynamic environment and manage multiple priorities. Proficiency in ERP systems (e.g., SAP) and Microsoft Office tools. Problem-solving mindset with a proactive approach to customer service. Fluency in English; additional European languages are a strong advantage. Other information Apply to our vacancy for more information. Looking forward to getting in touch!   

Company A global healthcare business focused on improving prevention, treatment, and patient outcomes through science and innovation. Job Description We are looking for a Pharmacovigilance Officer (Junior) to support patient safety within a cross-functional team in Amsterdam. This role focuses on accurate and timely handling of pharmacovigilance information, assisting with assessment of incoming safety data, and helping to identify any emerging safety, quality, or regulatory concerns. Responsibilities - Manage your own workload and ensure timely processing of incoming pharmacovigilance information - Handle inbox management and support case assessment and processing activities - Follow up with relevant reporters (including patients, healthcare professionals, and associated vendors) to obtain additional details needed for case assessment - Ensure potential safety, quality, and regulatory issues are identified quickly and escalated appropriately - Support compliance activities and maintain local pharmacovigilance quality documentation - Contribute to educational materials management - Participate in safety data review to spot trends, clusters, and pattern variances - Provide pharmacovigilance training to key stakeholders (both internally and externally) Requirements - Approx. 2 years of relevant experience in pharmacovigilance or a closely related safety role - Dutch required - Strong attention to detail and ability to manage workload independently - Experience handling safety cases and reviewing pharmacovigilance data - Ability to communicate professionally with multiple stakeholders to request additional case information 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 global biopharmaceutical organization focused on developing innovative treatments for rare diseases, neurology, immunology, and other specialized healthcare areas. Job Description We are looking for a Drug Safety Specialist to support the monitoring, assessment, and reporting of drug safety information. This role ensures that safety data is reviewed in line with regulatory requirements and internal procedures, helping maintain strong pharmacovigilance standards. Responsibilities -Collect, review, and evaluate adverse event and safety information from internal and external sources -Ensure timely and accurate regulatory reporting and documentation in accordance with applicable rules -Conduct data quality checks and follow up on missing or unclear safety information -Support signal detection activities and contribute to safety trend monitoring where required -Maintain up-to-date pharmacovigilance records and ensure audit readiness -Assist with preparation and review of safety documents, as needed -Collaborate with internal teams and external partners to ensure consistent safety processes Requirements -Experience in pharmacovigilance (or a strong safety/compliance background within pharma/healthcare) -Strong knowledge of pharmacovigilance reporting and regulatory expectations -Familiarity with case processing, safety databases, and document control -Excellent attention to detail and ability to manage priorities in a compliance-focused environment -Strong communication skills and the ability to work cross-functionally -Ability to work effectively in an international regulatory environment (Netherlands/European context) Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company: We are a trusted engineering solutions partner providing connectivity software and testing support across a wide range of products. Our teams specialise in delivering high-quality connectivity solutions, working from early proof-of-concept through to software release. Job Description: We are looking for a Senior Embedded Connectivity Software Engineer to support the development and release of new connectivity solutions. In this role, you will lead advanced embedded software proof-of-concept activities, collaborate on requirements and system design, and build testable, well-documented embedded C++ solutions for connectivity platforms—helping the team validate new chips and initial hardware quickly and effectively. Responsibilities: •    Perform proof-of-concept work, including evaluating new chipsets and supporting early hardware bring-up where needed •    Design and implement embedded C++ software for connectivity platforms •    Participate in the full engineering cycle: requirements definition, design, implementation, testing, and release •    Ensure software meets requested quality norms and participates in quality assurance activities •    Contribute to design and code reviews, including participation in FMEAs •    Build automated unit and integration tests using the chosen frameworks •    Estimate your work effort, provide input to planning, and maintain personal and team backlogs •    Create and follow structured schedules, reporting progress in a clear and consistent way •    Maintain proper documentation for PoC and software delivered to receiving teams •    Collaborate with electronics engineers during board bring-up and hardware validation •    Support PoC maturity by communicating acceptance criteria clearly to the teams that will take over Requirements: •    Bachelor’s or Master’s degree in software engineering or computer science •    Minimum 8 years of relevant experience in embedded software development •    Strong embedded software expertise in modern C++, object-oriented design, and SOLID principles •    Experience with connectivity technologies such as BLE, Wi Fi, and cellular product development •    Hands-on ability with hardware debugging and low-level integration (e.g., board-level debugging, reading datasheets, serial/inter-processor communication such as SPI/I2C) •    Comfortable working with microcontroller concepts (architecture, register sets, memory layout, interrupts) and vendor SDKs/HAL layers (including HAL layer development) •    Experience with development workflows and tooling such as Git, CMake, and test/build automation •    Knowledge of build and quality concepts, including CI/CD (and familiarity with containers/tools where applicable) is an advantage •    Familiarity with RTOS is an advantage •    Experience with software in medical-device contexts (e.g., ISO13485, IEC62304) is an advantage •    Ability to work independently as well as in a Scrum team, with strong communication skills—especially with external partners Other Information: The role is based in Eindhoven, Netherlands, with global collaboration across engineering teams. We are looking for enthusiastic, curious engineers who thrive in proof-of-concept and exploratory environments with evolving or unclear requirements, and who communicate clearly with both internal and external stakeholders. If you are interested and want to apply, please submit your application via the apply button below and contact me.  

Company We are a healthcare-focused manufacturing organisation producing high-quality medicines in a highly regulated, GMP-controlled environment. Our success depends on skilled people who combine strong technical know-how with a clear quality mindset and a continuous improvement attitude. Job Description We are looking for a Manufacturing Process Technician (GMP) for Automated Production Lines to join our production team on a 3-shift schedule. In this role, candidates will operate and support (semi) automated manufacturing lines according to regulated processes, deliver planned performance, and help ensure product quality and full compliance. You will use process and equipment knowledge to monitor, troubleshoot, improve, and maintain stable, high-standard production outcomes. Responsibilities - Run a production line in line with regulated operating procedures and GMP expectations - Monitor process parameters and ensure production continuity using accurate reporting and documentation - Collect, document, and analyse process data at operator level - Execute change-overs and maintain correct process execution and setup accuracy - Perform administrative tasks in relevant ERP systems (e.g., SAP/MES) - Troubleshoot process issues and support problem-solving activities (e.g., RCA, 5 Whys, Kaizen) - Identify opportunities to eliminate waste and improve processes using Lean/continuous improvement methods - Escalate A-typical events appropriately and support escalation and resolution activities - Maintain effective communication with line leads, supervisors, and fellow operators - Complete thorough shift handovers, ensuring essential information is transferred - Participate in improvement and troubleshooting processes and support training compliance - Support related logistic processes as required to keep production running smoothly Requirements - Experience in a manufacturing environment as a process/technical operator in GMP/GDP or ISO-certified settings - Experience with Lean manufacturing and continuous improvement, including troubleshooting (e.g., 5 Whys, RCA, Kaizen, Poka Yoke, TPM, SMED, Fishbone) - Hold a Lean/Six Sigma Yellow or Green Belt (or equivalent) - Experience working with process/data systems (ERP/MES) such as SAP/MES - Strong working knowledge of Standard Operating Processes (SOPs) - Education: MBO (technical/process) and/or VAPRO A and VAPRO B; plus advanced Lean and/or Six Sigma training - Proficient in Office tools (Word/Excel/PowerPoint) - Structured, analytical, and quality-focused with ownership and accountability; able to work independently on improvements 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 Our client is a leading global biopharmaceutical organization focused on developing and manufacturing innovative therapies that improve and save lives. Operating in a highly regulated GMP environment, the company combines advanced science, engineering excellence, and continuous improvement initiatives to support large-scale manufacturing operations. To strengthen its Engineering, Validation, and Maintenance (EVM) organization, they are looking for a Senior Quality Engineer who will drive quality, compliance, and process excellence initiatives across a complex technical environment. Role Description As Senior Quality Engineer, you will be part of a multidisciplinary Engineering, Validation, and Maintenance organization and report directly to the Compliance Supervisor. You will act as the key quality representative for the department, ensuring maintenance, engineering, validation, and qualification activities are executed in compliance with GMP regulations and internal quality standards. In addition, you will play a leading role in driving process excellence initiatives, continuous improvement programs, and Lean methodologies to improve operational performance, quality systems, and organizational effectiveness. Key Responsibilities Act as the quality representative for the Engineering, Validation, and Maintenance organization. Ensure compliance of maintenance, engineering, validation, and qualification activities with GMP and regulatory requirements. Lead and support continuous improvement and process excellence initiatives across the department. Provide expert guidance on validation, qualification, deviations, CAPAs, events, and quality investigations. Support engineering and maintenance teams in applying Lean, Six Sigma, and process excellence methodologies. Develop and maintain performance metrics, dashboards, and quality indicators to monitor departmental performance. Lead and support internal audits, quality assessments, and compliance improvement activities. Perform risk assessments and provide guidance on GMP, Annex 11, validation, and qualification requirements. Collaborate with cross-functional stakeholders to improve processes, communication, and operational effectiveness. Drive sustainable improvements in quality systems, compliance processes, and organizational performance. Requirements Bachelor's degree in Mechanical Engineering, Electrical Engineering, Process Engineering, Installation Technology, or a related technical discipline. 5+ years of experience in a Quality Engineering, Compliance, Validation, or Process Excellence role. Strong experience within a GMP-regulated pharmaceutical, biotechnology, life sciences, or process industry environment. Solid understanding of validation, qualification, GMP compliance, Annex 11, CAPA management, deviations, and risk assessments. Experience with Process Excellence, Lean, Six Sigma, or continuous improvement methodologies. Green Belt and/or Yellow Belt certification is highly preferred. Knowledge of pharmaceutical regulations and industry standards such as FDA, GMP, ICH, ASTM, and ISPE.