HR Operations Specialist, Oudkarspel, Noord-Holland

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 The client is a Dutch/Belgian food manufacturing company focused on frozen snacks, meal components, and private-label food products across Europe. Role Description The Interim Production Team Lead is responsible for leading, coaching, and developing a team of production employees while ensuring the efficient execution of the production plan. The role oversees daily operations to ensure production targets are achieved in line with established standards for safety, quality, productivity, hygiene, and compliance. This is a hands-on leadership position that combines people management, operational oversight, problem-solving, and continuous improvement within a manufacturing environment. Responsibilities Lead, motivate, and manage a team of production employees. Ensure compliance with safety, quality, hygiene, technical, and production standards across the department. Coordinate and monitor daily production activities to deliver planned output according to the production schedule. Manage workforce planning, shift schedules, operational meetings, and performance analysis to optimize production efficiency. Participate in and/or lead cross-functional projects and improvement initiatives. Identify and implement process improvement opportunities to enhance operational performance. Coordinate technical priorities and maintenance activities in collaboration with the Technical Services department and direct management. Investigate production deviations and customer complaints, identify root causes, and implement corrective and preventive actions. Train, coach, and develop team members to improve performance and capabilities. Support and execute company HR policies and procedures. Contribute to the development and maintenance of operational procedures, work instructions, and best practices. Monitor key performance indicators and drive continuous improvement in operational results. Requirements MBO+/HBO level of education or equivalent working and thinking level. Minimum of 3 years of experience in a production or logistics environment, preferably in a similar supervisory or team leadership role. Experience leading teams within a manufacturing setting. Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint. Knowledge of HACCP and food safety standards. Understanding of Food Defense principles. Familiarity with allergen management requirements. Knowledge of workplace safety regulations and procedures. Experience with internal audits is preferred. BHV (Emergency Response) certification or willingness to obtain. VOP NEN 3140 certification or willingness to obtain. Relevant on-the-job training and manufacturing compliance training. Strong leadership and coaching skills. Excellent planning and organizational abilities. Analytical and problem-solving mindset. Results-oriented with a focus on safety, quality, and operational excellence. Effective communication and stakeholder management skills. Continuous improvement mindset with the ability to drive change and engage teams. Other information   Apply to our vacancy for more information. Looking forward to getting in touch! 

Company Our client is a fast-growing biopharmaceutical organization operating in a highly regulated environment. They develop innovative therapies and work with high standards for quality, safety, and compliance. The culture is collaborative and hands-on, with a strong focus on continuous improvement and delivering reliable results. Job Description For our client in Hoofddorp, we are looking for a QC Microbiologist. In this role, the analyst supports routine microbiology activities within a GMP environment, with a strong focus on cleanroom environmental monitoring, sterility-related activities, and accurate documentation. The QC Microbiology Analyst works within a larger QC team and contributes to reliable daily operations and department improvements. Responsibilities - Perform cleanroom environmental monitoring, including air and surface monitoring. - Execute routine microbiological activities such as sterility testing support and plate reading. - Ensure accurate data entry, review, and support trending of test results. - Maintain a clean and compliant laboratory environment, including routine equipment and workspace upkeep. - Support departmental projects and other QC microbiology tasks as required. - Work according to GMP procedures and follow safety and quality standards consistently. - Participate in the shift schedule as required (day and evening shifts). Requirements - MLO level 3 or a Bachelor’s degree (preferably in Microbiology). - Up to 4 years of microbiology laboratory experience, ideally including cleanroom environmental monitoring. - Practical experience with microbiological techniques such as air monitoring and surface monitoring. - Strong understanding of aseptic techniques and working in/around cleanroom environments. - Basic knowledge of GMP, regulations, and quality control processes. - Comfortable with routine documentation and using Microsoft Office (Word/Excel/PowerPoint). - Good communication skills in English. Other Information This position is based on-site in Hoofddorp and is performed in a regulated environment with a shift schedule. If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company A global biotechnology organization focused on developing innovative cell therapies and advanced treatments for patients with serious diseases. The company operates in a highly regulated manufacturing environment with a strong commitment to quality, scientific excellence, and patient care. Role description As a Microbiology Analyst, you will support microbiological quality control activities within a GMP regulated environment. The role focuses on environmental monitoring, microbiological testing, data review, and maintaining laboratory operations. This position offers the opportunity to work in a collaborative team supporting the production of life changing therapies. Responsibilities - Perform environmental monitoring activities in cleanroom environments - Conduct microbiological testing including sterility testing and plate reading - Enter, review, and trend microbiological data and assay results - Maintain laboratory equipment and laboratory workspaces - Support departmental improvement initiatives and projects - Follow GMP requirements and quality standards - Assist with additional quality control activities as required Requirements - MLO Level 3 qualification or Bachelor's degree in Microbiology preferred - 0 to 4 years of microbiology laboratory or environmental monitoring experience - Experience with air monitoring and surface monitoring techniques - Knowledge of aseptic techniques and cleanroom operations - Understanding of GMP regulations and quality control processes - Ability to work in controlled cleanroom environments - Ability to lift approximately 12 kg - Proficiency with Microsoft Word, Excel, PowerPoint, and related applications - Strong verbal and written English communication skills - Ability to work in a fast paced and changing environment - English language proficiency at B1 level or higher 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 global biopharmaceutical organization developing innovative cell therapies for cancer treatment. The QC Microbiology team works in a GMP environment supporting the quality and safety of advanced therapies. Role Description As a QC Microbiology Analyst, you will perform microbiological testing and environmental monitoring in a controlled GMP environment. You will work as part of a multidisciplinary team and contribute to reliable laboratory operations and quality control. Key Responsibilities Perform environmental monitoring of cleanrooms Perform microbiological assays, including sterility testing and plate reading Enter, review, and trend microbiological data Maintain laboratory equipment and work areas Follow GMP and quality control procedures Support QC Microbiology projects and improvement activities Requirements MLO level 3 or Bachelor's degree in Microbiology 1+ years of microbiology laboratory or environmental monitoring experience Experience with air and surface monitoring Experience with aseptic techniques and cleanroom operations Knowledge of GMP and quality control processes Good English communication skills; Dutch is not required Comfortable working in a fast-paced environment Willing and able to work an 18-week rotating shift schedule

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

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

Company A leading global organization in the life sciences sector is expanding its manufacturing operations in the Netherlands. The site works in a highly regulated environment, with a strong focus on quality, compliance, and continuous improvement. The organization is investing in new and upgraded production and packaging equipment and is strengthening its engineering capabilities to support long-term operational readiness. Job Description For a production site in Breda, we are looking for an Equipment Automation Engineer to support the automation scope of new and upgraded manufacturing equipment. The Equipment Automation Engineer (Packaging & Inspection) will take ownership of automation deliverables across the full equipment lifecycle—design, installation, commissioning, and ongoing support—working closely with engineering, manufacturing, quality, and external equipment suppliers. Responsibilities - Leading automation activities for equipment projects in Device Assembly, Inspection, Labelling, and Packaging areas - Writing and/or reviewing key automation and engineering documentation (e.g., URS, FDS, HDS, SDS) - Supporting installation, testing, commissioning, and qualification activities (including vendor testing phases where needed) - Ensuring systems align with site and network security requirements (e.g., domain settings, firewall considerations) - Implementing internal automation standards for both hardware and software - Installing required monitoring tools and supporting data integrity assessments - Performing or supporting automation preventive maintenance assessments - Advising on automation spare parts and contributing to asset spare parts lists - Creating, testing, and maintaining backup/restore procedures and work instructions for configurable components - Creating parameter management and audit trail review work instructions - Creating and updating Asset Parameter Lists (APLs) - Supporting integration to a PI data historian (or similar data platform) - Training maintenance/engineering teams and relevant operators on automation-related topics - Providing “hypercare” support on the shop floor after implementation as required - Providing progress updates and reporting to (project) management and key stakeholders Requirements - Bachelor’s or Master’s degree in Industrial Automation Engineering, Industrial Information Systems, or similar - At least 5 years’ experience delivering automation / process control / information systems support in a regulated manufacturing environment (biotech, pharma, or similar) - Proven experience running workstreams independently within cross-functional project teams - Experience with labelling and packaging equipment is essential - Working knowledge of industrial automation technologies such as PLC, HMI, SCADA, industrial - PCs, and vision systems (e.g., Cognex) - Strong understanding of working in regulated environments (e.g., GMP) - Fluent in English (written and spoken) - Willingness to occasionally work outside office hours when project activities require it Other Information This position is based on-site in Breda, the Netherlands, and offers the opportunity to contribute to high-impact equipment projects within a modern, regulated production environment.

Company  A leading organization within the manufacturing sector dedicated to delivering high-quality, innovative solutions. The company values technical excellence, teamwork, and continuous improvement to ensure operational success and sustainability. Job Description We are seeking a proactive and experienced Senior Automation Engineer to join our dynamic team in Breda. This role focuses on overseeing automation systems involved in the installation, commissioning, and lifecycle management of advanced manufacturing equipment, particularly in device assembly, inspection, labeling, and packaging areas. The ideal candidate will ensure equipment reliability, security, and optimal performance through expert automation practices. Responsibilities Manage automation aspects of new equipment installations and upgrades, ensuring alignment with project timelines. Support New Product Introduction (NPI) and coordinate test phases at equipment vendors and on-site. Oversee automation design, including review and creation of technical documents such as URS, FDS, HDS, and SDS. Support equipment installation, testing, commissioning, and validation, considering network security settings. Ensure equipment security using Amgen standards and support the connection to data historians like PI. Participate in FAT, commissioning, and qualification activities. Conduct automation preventive maintenance and data integrity assessments. Advise on spare parts and develop asset spare parts lists for automation equipment. Create backup and restore procedures, parameter review protocols, and audit trail review procedures. Support automation training for Maintenance, Engineering, and Operators. Provide operational hypercare support and update documentation to maintain operational effectiveness. Requirements Bachelor’s or master’s degree in Industrial Automation Engineering or related fields. Minimum of 5 years’ experience in process control and information systems support within biopharmaceutical or pharmaceutical manufacturing environments. Proven ability to execute independent projects in cross-functional, global teams. Hands-on experience with labelling and packaging equipment, including PLC, HMI, SCADA, Cognex vision systems, and industrial PCs. Familiar with regulated environments (GMP, OSHA, EPA). Strong knowledge of automation standards, network security, and data management. Excellent communication skills in English, both written and spoken. Ability to work outside regular hours when necessary. 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 public organization dedicated to ensuring the safety, accessibility, and sustainability of national infrastructure. They are involved in large-scale projects that contribute to maintaining and improving key transport connections and public assets across the Netherlands. Job Description We are seeking an experienced Senior Project Controls Coordinator to support the management of maintenance and renewal projects for bridges in Zeeland. This role involves establishing and maintaining effective project control processes, providing vital oversight, and ensuring projects are delivered on time, within scope, and within budget. The successful candidate will be instrumental in building the project controls framework from the ground up, contributing to the safe and efficient operation of bridge infrastructure. Responsibilities -Develop, implement, and oversee project control systems across multiple bridge maintenance and renewal projects. -Ensure accurate tracking and reporting of project scope, schedule, finances, risks, quality, and documentation. -Provide clear insights and highlight potential issues or blind spots within project controls. -Collaborate with project teams to establish aligned processes for planning, budgeting, risk management, and quality assurance. -Translate findings into actionable recommendations for decision-making. -Liaise with colleagues to maintain high standards of project control quality and timeliness. -Lead and motivate a team of professionals, fostering a culture of accountability and continuous improvement. -Build the project controls framework in a relatively new environment, setting up processes and workflows from scratch. -Monitor project performance, anticipate challenges, and implement corrective measures where needed. -Ensure all project control activities comply with applicable frameworks and organizational standards. Requirements -Minimum of 5 years’ experience in project control or management. -Relevant higher education qualification (HBO level) in finance, economics, or business administration. -Solid understanding of the IPM model and the role of project controls within infrastructure projects. -Proven ability to establish project control processes independently from the ground up. -Strong leadership skills and experience in managing project control teams. -Excellent analytical skills, with the ability to identify and address control gaps. -Effective communicator, capable of working across disciplines and levels of the organization. -Flexibility to work on-site in Middelburg every Tuesday and adapt to project needs. -Proficiency in Dutch language. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.