Bioprocess Validation Engineer, Leiden, Zuid-Holland

Company: A global biotechnology company dedicated to improving patients' lives through innovative medicines. The Breda manufacturing site is a highly automated, GMP-regulated facility responsible for the production, labeling, assembly, and distribution of medicines to more than 75 countries worldwide. The company values innovation, operational excellence, continuous improvement, and collaboration while providing employees with excellent career development opportunities. Job Description: As a Technical Operator (GMP) – Automated Manufacturing, you'll play an important role in the day-to-day running of our manufacturing operation. Working within a GMP-regulated environment, you'll help ensure products are produced safely, efficiently, and to the highest quality standards. You'll work with advanced production equipment, support troubleshooting activities when issues arise, and help keep manufacturing processes running smoothly. Whether it's operating equipment, carrying out routine checks, recording production data, or identifying improvements, you'll be a key part of a team focused on delivering reliable results. This position is ideal for someone who enjoys a hands-on technical role, likes solving problems, and wants to contribute to a modern manufacturing environment where quality, safety, and continuous improvement are at the heart of everything we do. Responsibilities: Ensure production activities are completed according to GMP, quality, and safety standards. Operate automated equipment used for manufacturing, assembly, labeling, and packaging activities. Prepare production lines for new batches, including equipment set-up, changeovers, cleaning, and line clearance activities. Review and record manufacturing data using digital systems such as SAP and Manufacturing Execution Systems (MES). Investigate process deviations and support Root Cause Analysis (RCA / 5 Why) to prevent recurring issues. Identify opportunities to improve workflows, equipment performance, and operational efficiency through Lean Manufacturing and Continuous Improvement initiatives. Work closely with colleagues from Production, Engineering, Maintenance, and Quality teams to solve day-to-day operational challenges. Perform routine inspections, equipment adjustments, and basic first-line maintenance tasks. Monitor production performance and take appropriate action when abnormalities occur. Support a culture of teamwork, innovation, operational excellence, and continuous improvement. Requirements: This opportunity is ideal for someone who enjoys working in a technical environment, likes finding practical solutions, and takes pride in maintaining high standards of quality and compliance. We'd love to hear from you if you have: MBO-level technical qualification or equivalent experience. Experience working within manufacturing, production, processing, or other industrial operations. Experience operating or supporting automated machinery or technology-driven production environments. Strong problem-solving skills with a structured approach to troubleshooting. Previous experience within a GMP-regulated or other quality-controlled industry, such as pharmaceuticals, biotechnology, medical devices, food production, or chemicals. Knowledge of GMP requirements and quality-focused ways of working. Experience with production software or digital manufacturing systems such as SAP, MES, or similar platforms. A proactive attitude with a high level of ownership, accountability, and attention to detail. Good communication skills in English. Willingness to work a rotating 3-shift or 5-shift schedule. Other Information: This is an excellent opportunity to join a global biotechnology leader and work in a highly automated, GMP-regulated manufacturing environment. You'll benefit from competitive compensation, career development opportunities, and a collaborative, innovative workplace while contributing to the production of life-changing medicines for patients worldwide. If you are interested and would like to apply, please submit your application via the apply button below or contact me for more information

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. To support growing production activities, we are looking for several hands-on professionals who enjoy working with machinery, solving technical problems, and improving production processes.   Job Description As a Production Operations Technician, 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.  

About the Company Our client is a global biotechnology leader dedicated to improving patients' lives through innovative medicines. Operating advanced, highly automated manufacturing facilities, the company is committed to quality, safety, innovation, and continuous improvement while offering excellent opportunities for professional growth. Role Description As an Equipment Operator, you will operate and optimize automated production and packaging equipment, troubleshoot technical issues, perform minor maintenance, and support continuous improvement initiatives. Working in a GMP-regulated environment, you will help ensure safe, efficient, and reliable manufacturing while contributing to operational excellence and product quality. Responsibilities - Manage and oversee automated production and packaging lines, ensuring safe and efficient operations. - Perform equipment setup, product changeovers, line clearances, and routine cleaning activities. - Diagnose and resolve technical issues to minimize downtime and optimize equipment performance. - Carry out minor maintenance tasks and machine adjustments to support operational reliability. - Record production activities and performance data using SAP and MES. - Support deviation investigations, root cause analysis (RCA), and continuous improvement initiatives. - Ensure compliance with GMP, quality, safety, and operational standards. Requirements - Experience operating automated production, assembly, packaging, or process equipment in a manufacturing environment. - Strong technical troubleshooting, analytical, and problem-solving skills. - Experience with Root Cause Analysis (RCA), 5 Why, or other structured problem-solving methodologies. - Familiarity with GMP-regulated environments and manufacturing systems such as SAP and MES. - A proactive mindset with a strong focus on safety, quality, continuous improvement, and operational excellence. - Ability to work independently as well as collaboratively in a fast-paced production environment. - Good communication skills in English and willingness to work in rotating 3-shift or 5-shift schedules. Other Information If you are interested and would like to apply, please submit your application using the Apply button below or contact me for more information.

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.

Over het bedrijf Sluit je aan bij een toonaangevende internationale farmaceutische producent waar geneesmiddelen worden geëtiketteerd, geassembleerd, opgeslagen en wereldwijd gedistribueerd. Je werkt in een GMP-gereguleerde productieomgeving en draagt bij aan betrouwbare productieprocessen, een hoge productkwaliteit en continue verbetering. Functieomschrijving Als Technical Operator – Semi-geautomatiseerde Productielijnen ben je verantwoordelijk voor het bedienen en bewaken van semi-geautomatiseerde productieapparatuur. Je zorgt ervoor dat het productieproces veilig, efficiënt en volgens de geldende kwaliteits- en GMP-richtlijnen verloopt. Daarnaast voer je machine-instellingen uit, los je technische en procesmatige storingen op, houd je productiegegevens nauwkeurig bij en draag je bij aan verbeterinitiatieven binnen een gestructureerde productieomgeving. Verantwoordelijkheden Bedienen en bewaken van semi-geautomatiseerde productie- en verpakkingslijnen. Uitvoeren van machine-instellingen, omstellingen, line clearance-werkzaamheden en reinigingsactiviteiten. Oplossen van storingen aan apparatuur en productieprocessen en uitvoeren van kleine machineafstellingen. Vastleggen van productieactiviteiten en batchgegevens in SAP- en MES-systemen. Ondersteunen bij afwijkingsonderzoeken (deviation investigations) en productiegerelateerde triageactiviteiten. Actief bijdragen aan Lean- en Continuous Improvement-initiatieven. Waarborgen van naleving van GMP-, veiligheids- en kwaliteitsrichtlijnen. Werken volgens SOP's (Standard Operating Procedures) en werkinstructies om een efficiënt productieproces te waarborgen. Bijdragen aan optimale prestaties van de apparatuur en een betrouwbare productie. Functie-eisen Afgeronde MBO-opleiding in een technische richting of een vergelijkbaar opleidingsniveau. Ervaring met het bedienen van productie-, assemblage-, etiketteer- of verpakkingsapparatuur. Technisch inzicht in productieprocessen en productieapparatuur. Sterke analytische vaardigheden en ervaring met het oplossen van technische storingen. Ervaring met Root Cause Analysis (RCA), 5 Why of vergelijkbare probleemoplossingsmethodieken is een pré. Ervaring binnen een GMP-omgeving of een andere gereguleerde productieomgeving. Ervaring met SAP en/of MES-systemen. Kennis van Lean Manufacturing of Continuous Improvement is een pré. Proactieve, nauwkeurige en kwaliteitsgerichte werkhouding. Goede beheersing van de Engelse taal. Bereidheid om te werken in een 3-ploegendienst, met de mogelijkheid om in de toekomst over te gaan naar een 5-ploegendienst. Arbeidsvoorwaarden Fulltime functie. Marktconform salaris met aantrekkelijke ploegentoeslagen. Ruime opleidings- en doorgroeimogelijkheden. Moderne GMP-productieomgeving met veel aandacht voor veiligheid, kwaliteit en het welzijn van medewerkers.

Over het bedrijf Sluit je aan bij een toonaangevende internationale farmaceutische producent waar geneesmiddelen worden geëtiketteerd, geassembleerd, opgeslagen en wereldwijd gedistribueerd. Je werkt in een hoog geautomatiseerde GMP-productieomgeving en draagt bij aan een betrouwbare productie, continue verbetering en operationele excellentie. Functieomschrijving Als Technical Operator – Geautomatiseerde Productielijnen ben je verantwoordelijk voor het bedienen, bewaken en optimaliseren van volledig geautomatiseerde productielijnen. Je zorgt ervoor dat het productieproces veilig, efficiënt en volgens de geldende kwaliteits- en GMP-richtlijnen verloopt. Daarnaast speel je een belangrijke rol bij het oplossen van technische storingen, het verbeteren van de prestaties van de apparatuur en het waarborgen van een hoge productkwaliteit binnen een gereguleerde productieomgeving. Verantwoordelijkheden Bedienen en bewaken van volledig geautomatiseerde productie- en verpakkingslijnen. Uitvoeren van machine-instellingen, omstellingen, line clearance-werkzaamheden en reinigingsactiviteiten. Oplossen van storingen aan apparatuur en productieprocessen met behulp van gestructureerde probleemoplossingsmethodieken. Uitvoeren van klein technisch onderhoud en mechanische of parametertechnische afstellingen. Vastleggen van productieactiviteiten en batchgegevens in SAP- en MES-systemen. Ondersteunen bij afwijkingsonderzoeken (deviation investigations) en productiegerelateerde triageactiviteiten. Uitvoeren van Root Cause Analyses (RCA, 5 Why) en implementeren van corrigerende maatregelen. Actief bijdragen aan Lean- en Continuous Improvement-initiatieven. Waarborgen van naleving van GMP-, veiligheids- en kwaliteitsrichtlijnen. Bijdragen aan optimale prestaties van de productielijnen en een efficiënte productie. Functie-eisen Afgeronde MBO-opleiding in een technische richting of een vergelijkbaar opleidingsniveau. Ervaring met het bedienen van volledig geautomatiseerde productie-, assemblage-, etiketteer- of verpakkingslijnen. Sterke analytische vaardigheden en ervaring met het oplossen van technische storingen. Ervaring met Root Cause Analysis (RCA), 5 Why of vergelijkbare probleemoplossingsmethodieken. Ervaring binnen een gereguleerde productieomgeving; ervaring met GMP is een sterke pré. Ervaring met SAP en/of MES-systemen. Kennis van Lean Manufacturing of Continuous Improvement is een pré. Proactieve, kwaliteitsgerichte werkhouding en in staat om zelfstandig te werken. Goede beheersing van de Engelse taal. Bereidheid om te werken in een 3-ploegendienst, met de mogelijkheid om in de toekomst over te gaan naar een 5-ploegendienst. Arbeidsvoorwaarden Fulltime functie. Aantrekkelijke ploegentoeslagen en goede arbeidsvoorwaarden. Uitgebreide opleidings- en ontwikkelmogelijkheden. Moderne productieomgeving met veel aandacht voor veiligheid, kwaliteit en het welzijn van medewerkers.

Company Our client is an international manufacturing company known for operating within a highly regulated production environment. Using advanced automated manufacturing and packaging technologies, the organisation is committed to delivering high-quality products while maintaining the highest standards of safety, compliance, and operational excellence. Continuous improvement, teamwork, and innovation are key drivers of success across the site. Job Description We are currently seeking an Automated Production Line Technician (GMP) to join a dynamic production team. In this position, you will be responsible for ensuring automated production lines operate efficiently, safely, and in accordance with GMP guidelines. You will play an important role in maintaining equipment performance, resolving technical issues, and supporting production continuity through proactive problem-solving and process optimisation. Key Responsibilities - Work with automated production and packaging equipment in accordance with GMP requirements and standard operating procedures. - Prepare production lines for operation by carrying out equipment set-ups, product changeovers, cleaning activities, and line clearance procedures. - Investigate and resolve equipment faults and process disruptions to minimise production downtime. - Fine-tune machine settings and process parameters to improve productivity, efficiency, and product quality. - Register and verify production information using SAP, MES, and related manufacturing systems. - Complete production documentation accurately, including batch records, equipment logs, and operational documentation. - Assist with deviation investigations and support root cause analysis using structured troubleshooting methodologies. - Collaborate with Production, Maintenance, and Quality teams to resolve technical issues and restore production performance. - Drive continuous improvement initiatives by applying Lean principles and identifying opportunities to optimise manufacturing processes. - Promote a safe working environment while ensuring effective communication during shift handovers. Requirement - Technical education at MBO level or an equivalent qualification such as VAPRO B. - Previous experience within automated production, assembly, packaging, or process manufacturing. - Strong technical aptitude with proven troubleshooting and analytical problem-solving skills. - Familiarity with structured improvement methodologies including Root Cause Analysis (RCA), 5 Why, Lean, or Kaizen. - Experience working within GMP or another regulated manufacturing environment is highly desirable. - Knowledge of SAP, Manufacturing Execution Systems (MES), or comparable production software. - Good communication skills in English. - Flexible to work rotating 3-shift and 5-shift schedules. - Available for a temporary full-time assignment via SIRE Life Sciences. Why Apply? This opportunity is ideal for someone who enjoys working with advanced manufacturing technology and takes pride in improving production performance. You'll become part of an environment where technical expertise, teamwork, and continuous improvement are valued every day. If you're looking for your next challenge in automated manufacturing, we'd love to hear from you. Apply today by clicking the application button below or contact me directly for more information.

The Company Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions. Role Description As a Production Operator, you will be responsible for operating and maintaining semi-automated production and packaging lines within a GMP-regulated manufacturing environment. You will ensure production processes run safely, efficiently, and in compliance with quality standards while supporting continuous improvement initiatives and minimizing production downtime. Responsibilities Run and oversee production machines to keep operations running smoothly. Prepare equipment for new production batches and switch products when needed. Spot and fix minor machine issues to reduce downtime. Enter and update production records using the company's systems. Help investigate production issues and support practical solutions. Suggest ideas to improve efficiency, quality, and daily operations. Follow safety, quality, and company procedures at all times. Work closely with your team to achieve daily production goals. Requirements A technical background or hands-on experience in a production or manufacturing environment. Previous experience working with production machinery or automated equipment. Comfortable troubleshooting basic machine or process issues. Experience in industries such as pharmaceuticals, biotechnology, food, medical devices, or other regulated environments is a plus. Familiarity with production systems such as SAP or similar software is an advantage. A proactive mindset with a willingness to learn and improve processes. Good communication skills in English. Willingness to work rotating 3-shift or 5-shift schedules. Other Information This is an excellent opportunity to join a global, high-tech manufacturing environment where you'll work with advanced automation technologies while developing your technical skills and career. A competitive salary, shift allowances, bonus, 13th-month salary, holiday allowance, and excellent development opportunities are offered. Apply to our vacancy for more information. We look forward to hearing from you!

The Company Our client is a global food and beverage company committed to bringing health through food to as many people as possible. With leading brands across Dairy, Plant-Based, Waters, and Specialized Nutrition, the company combines innovation, sustainability, and science to create healthier products for consumers worldwide. Role Description As an Executive Assistant, you will provide high-level administrative support to senior leadership by managing complex calendars, coordinating international travel, organizing executive meetings and events, and handling confidential communications. You will act as a trusted partner, ensuring smooth day-to-day operations while collaborating with internal and external stakeholders in a fast-paced international environment. Responsibilities Manage complex calendars, schedules, and inboxes for senior executives, ensuring efficient time management and meeting coordination. Coordinate domestic and international travel arrangements, including flights, hotels, visas, and transportation. Organize leadership meetings, workshops, conferences, and events, including preparing agendas, presentations, meeting minutes, and tracking action items. Act as the primary point of contact for internal and external stakeholders, ensuring effective communication and administrative support. Handle purchase orders, expense reports, vendor coordination, and other day-to-day administrative activities. Support ad hoc projects, maintain organizational documents, contact lists, and reports, while creating presentations and performing basic Excel analysis. Requirements Proven experience as an Executive Assistant, Management Assistant, Personal Assistant, or in a similar executive support role. Experience supporting senior leaders such as Directors, VPs, SVPs, or C-level executives in a fast-paced corporate environment. Strong organizational and multitasking skills, with the ability to manage multiple priorities and confidential information. Proficiency in Microsoft Office Suite, particularly Outlook, PowerPoint, Excel, and Word. Excellent communication and stakeholder management skills, with the ability to collaborate across various business functions. Fluent in English; previous experience in multinational, FMCG, pharmaceutical, or corporate environments is highly preferred. Other Information This is a 3-month contract opportunity, offering a part-time schedule of 24 hours per week. Apply to our vacancy for more information. We look forward to hearing from you!

The Company A leading manufacturer within the food and dairy processing industry, operating large scale production facilities and investing significantly in modernization and operational excellence. The organization focuses on advanced processing technologies, product quality, and efficient production of food products for international markets. Role Description An experienced Commissioning & Start Up Manager is required to lead a major capital investment project involving a new UHT system, homogenizer, and aseptic storage tank. The role is focused on ensuring a successful transition from construction to commercial production while managing commissioning, qualification, validation, and stakeholder alignment. The successful candidate will provide structure, leadership, and objective planning to ensure realistic project timelines and successful customer acceptance. Responsibilities - Develop and execute the overall Commissioning and Start Up strategy and plan - Lead all commissioning and start up activities from mechanical completion through commercial production - Coordinate project teams, site operations, suppliers, quality teams, and customers - Manage stakeholder communication and alignment throughout the project lifecycle - Support qualification and validation activities in compliance with project requirements - Ensure customer requirements and product acceptance criteria are incorporated into start up plans - Review project schedules and challenge assumptions where necessary Identify project risks and develop mitigation plans - Create realistic milestones and commissioning schedules - Support customer discussions regarding project status and achievable delivery timelines - Drive documentation, compliance, and operational readiness activities Requirements - Proven experience as a Commissioning and Start Up Manager on large scale industrial projects - Strong experience with commissioning, qualification, validation, and operational readiness - Background in food, dairy, beverage, pharmaceutical, or process industries - Experience with customer facing projects and complex stakeholder management - Ability to review and challenge project plans constructively - Strong leadership and communication skills - Experience working with suppliers, project managers, and operational teams - Knowledge of GMP environments is highly desirable - VCA certification required, VCA Full preferred - Fluent Dutch and English language skills - Strong documentation and coordination expertise Other Information - Shift Work: Occasional participation in shift operations may be required during commissioning activities - Onsite Requirement: Primarily onsite with occasional remote working possibilities