Carrières dans les sciences de la vie

• Participer aux activités de Commissioning & Qualification (IQ, OQ, PQ) des équipements, installations et utilités critiques (HVAC, WFI, autoclaves, etc.). 
• Rédiger et réviser la documentation de validation : protocoles, rapports, évaluations de risques, plans de validation. 
• Assurer le suivi des CAPA liés à la qualification. 
• Collaborer étroitement avec les équipes engineering, QA, production et maintenance. 
• Garantir la conformité aux exigences GMP, FDA, EMA et autres standards en vigueur. 
• Participer activement à l’amélioration des processus de validation et de la documentation associée. 
• Contribuer à la gestion de projets de mise en service ou de modification d’équipements/utilités. 

Sluit je aan bij een innovatief team waar jouw expertise bijdraagt aan baanbrekende projecten in de farmaceutische automatisatie. Wij zijn op zoek naar een gedreven professional die impact wil maken in een dynamische omgeving.

Als ideale kandidaat ben je een ervaren Senior CSV Engineer met een passie voor automatisatiesystemen. Je bent communicatief vaardig, proactief en altijd op zoek naar verbeteringen. Als jij detailgericht, technisch onderlegd en enthousiast over automatisatie bent, dan is deze rol misschien perfect voor jou.

• Je stelt, voert uit en documenteert Computer System Validation (CSV)-activiteiten conform GMP-richtlijnen.
• Je test, kwalificeert en valideert procesautomatiseringssystemen, inclusief DeltaV en PCS 7.
• Je analyseert wijzigingen in systemen en bepaalt de impact op validatie.
• Je coördineert validatieactiviteiten met interne en externe stakeholders.
• Je draagt actief bij aan de optimalisatie van automatiseringsprocessen.
• Je fungeert als technisch aanspreekpunt op de werkvloer.

• Ensure compliance with GxP
• Manage deviations and CAPAs
• Review and approve SOPs and protocols
• Support risk assessments and change control processes
• Collaborate with cross-functional teams on quality-related matters
• Oversee document control and quality systems management

Join a dynamic team dedicated to driving innovation in pharmaceutical projects. We are seeking a motivated professional committed to excellence and compliance in a fast-paced environment.

As the ideal candidate, you are an experienced Project Commissioning & Qualification Lead eager to leverage your technical expertise and leadership skills. This role focuses on project execution and involves collaborating across diverse functions, making it an exciting opportunity for a proven leader in the field.

• You act as the primary C&Q Project Lead on a small molecule site capacity expansion project.
• You lead and manage a team of approximately 20 C&Q Engineers to deliver the C&Q project scope including Facilities and Utilities and Process Equipment.
• You lead and participate in the development and execution of C&Q documentation in accordance with internal Quality Standards, cGMP requirements, and client procedures.
• You manage C&Q team safety during the project.
• You manage scope execution by effectively scheduling, coordinating, mentoring, and reviewing project activities with appropriate stakeholder groups.
• You interact effectively with project stakeholders to execute an efficient and compliant C&Q program.

Rejoignez une équipe dynamique où votre expertise fera la différence dans des projets innovants au sein de lindustrie pharmaceutique. Ce poste est une excellente opportunité pour les professionnels désireux de contribuer à des activités de contrôle qualité dans un environnement stimulant.

Nous recherchons un(e) technicien(ne) de laboratoire en chimie et microbiologie passionné(e) et méthodique. Vous avez une solide expérience dans des environnements réglementés et vous êtes motivé(e) à travailler avec précision dans l'analyse scientifique.

• Vous réalisez le prélèvement, l'identification et la libération des matières premières.
• Vous effectuez des analyses physico-chimiques sur les matières premières et les milieux de culture.
• Vous réalisez des dosages des endotoxines.
• Vous menez des analyses microbiologiques et identifiez les bactéries par différentes méthodes.
• Vous effectuez des tests de stérilité sur divers milieux de culture.
• Vous assurez le nettoyage et l'entretien du laboratoire ainsi que de ses équipements.
• Vous contribuez à la révision des procédures QC et à la gestion des déviations.

Explore an opportunity where your expertise will contribute to maintaining compliance in the highly regulated field of Computerized Systems Validation. In a challenging and dynamic environment, you will play a crucial role in supporting teams that ensure quality and adherence to regulatory standards.

As the ideal candidate, you are an experienced Analyst in Quality Assurance with a solid background in CSV and an understanding of both European and US regulations. Your strong problem-solving skills and ability to navigate complex situations will be essential in this position.

• You assure that all CSV related regulatory requirements are fulfilled throughout the complete life cycle of computerized systems.
• You review and approve CSV documents such as SOPs, user requirements, and Validation Plans to maintain compliance with regulations.
• You collaborate with IT and engineering teams, providing support and guidance for CSV activities.
• You address deviations during CSV activities and ensure thorough follow-up.
• You evaluate incidents related to Computerized Systems and propose corrective actions as necessary.
• You prepare periodic compliance reports on quality systems and assist in system audits and inspections.
• You stay current with international regulations regarding CSV and implement improvements as needed.

Join a leading organization at the forefront of biopharmaceutical production, where your expertise will drive the development of cutting-edge upstream processes. This dynamic role is ideal for a professional eager to excel in a fast-evolving environment focused on therapeutic innovations.

As an ideal candidate, you are an experienced Upstream Process Engineer who is passionate about optimizing processes in the production of biologics. If you possess a blend of technical knowledge and problem-solving abilities, this opportunity is designed for you.

• You act as a customer’s SPOC for the design of the required equipment package, developing and optimizing upstream processes involving cell culture and fermentation.
• You collaborate with cross-functional teams to test all process equipment at the vendor shop and on site, documenting all required testing in relevant protocols and reports.
• You identify and resolve process-related and technical issues to maintain optimal production performance.
• You prepare and maintain detailed documentation of process equipment, user requirements, and design qualification protocols and reports.
• You ensure all processes comply with regulatory requirements and cGMP industry standards.

Join a cutting-edge environment where your expertise will drive the development and optimization of crucial processes within the biologics production industry. We are looking for a dedicated professional who can navigate the complexities of process engineering to enhance production efficiency and quality.

The ideal candidate is a knowledgeable Downstream Process Engineer with a strong foundation in both engineering principles and biotechnological applications. If you have a passion for innovation, problem-solving, and ensuring compliance in high-stakes environments, this role may be your next career step.

• You serve as the customer's single point of contact for the design of equipment packages, optimizing downstream processes such as purification and buffer preparation.
• You collaborate with cross-functional teams to test all process equipment during FAT/SAT both on-site and at vendor shops.
• You identify and troubleshoot process-related issues to maintain optimal production performance.
• You prepare and maintain comprehensive documentation for process equipment and validation protocols.
• You ensure all processes adhere to relevant regulatory requirements and cGMP industry standards.
• You provide support in the design and qualification of new equipment to meet project goals.
• You actively participate in process optimization initiatives to improve production efficiency and product quality.

Join a vibrant and innovative team at the forefront of the Biotech/Pharma industry, where your expertise will play a critical role in ensuring cutting-edge clean piping systems that adhere to the highest standards of safety and efficacy.

Our client is on the lookout for a proficient Clean Piping Engineer who is adept at navigating the complexity of clean utility systems. If you are passionate about design, integrity, and compliance, this opportunity is tailored for your skillset.

• You validate designs and layouts for clean piping systems to ensure optimal functionality.
• You select materials that comply with industry and company standards, ensuring system integrity.
• You ensure all piping systems meet regulatory and safety standards, including GMP (Good Manufacturing Practices).
• You oversee the installation and maintenance of piping systems while minimizing downtime and ensuring optimal performance.
• You conduct tests and validations to verify the reliability and safety of piping systems.
• You prepare and maintain comprehensive documentation, including design specifications and maintenance records.
• You collaborate closely with project managers, architects, contractors, and other engineers to integrate piping systems into overall project plans.
• You identify and resolve issues related to piping systems, proposing effective solutions to maintain system integrity.

Join a leading team dedicated to navigating the regulatory landscape within the pharmaceutical industry. Engage in meaningful work that impacts the development and delivery of life-saving products while ensuring adherence to regulatory standards across various markets.

We are seeking a knowledgeable Regulatory Strategist Consultant who is keen on supporting product registration activities and collaborating with multiple departments to enhance operational efficiency. If you thrive in a compliance-focused environment and are passionate about regulatory strategies, this role may be for you.

• You support regulatory submissions (CTD, BLA, NDA) by informing site colleagues of regulatory requirements and authoring the necessary documentation.
• You liaise with regulatory colleagues to communicate and resolve potential issues that may arise during the submission process.
• You collaborate with cross-functional teams and stakeholders to ensure high-quality CMC submissions and compliance across Pfizer's portfolio.
• You manage timely responses to Board of Health requests related to lifecycle submissions in your areas of responsibility.
• You assess post-approval changes at the manufacturing site and prepare the impacted sections of the dossier for regulatory variations.
• You contribute to project completion, manage your time effectively, and develop plans to support operational goals within a team environment.
• You utilize your scientific knowledge and analytical skills to produce clear and concise regulatory documentation.

Join a forward-thinking organization where your contributions will significantly enhance the efficiency and effectiveness of clinical trials. Here, you will play a pivotal role in navigating the complexities of clinical operations, ensuring the successful execution of studies that can impact lives.

We are seeking a detail-oriented and strategic professional to fill the role of Clinical Operations Study Country Lead (COSCL). The ideal candidate will possess robust operational management skills and a proven track record in clinical trials, demonstrating the ability to lead projects to successful conclusions.

• You set up local study country strategy and lead country start-up activities.
• You manage the execution of clinical studies ensuring compliance with study plans and timelines.
• You own the study budget at country/cluster level and ensure proper financial management.
• You facilitate effective communication among all local parties involved in the study.
• You maintain quality and compliance in data collection and patient safety metrics.
• You proactively address performance discrepancies and propose mitigation strategies.
• You represent your Clinical Study Unit at Core Study Team meetings.

Join a fast-paced environment where your expertise will significantly contribute to vital validation projects in the healthcare manufacturing sector. Our client is looking for a dedicated professional who is excited about ensuring compliance and excellence in regulatory practices.

As an ideal candidate, you are a skilled Validation Specialist focused on delivering high-quality results and driving improvements in regulatory compliance. If you have a keen eye for detail and a passion for operational integrity, this role could be the right fit for you.

• You develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for small scale equipment, including related software.
• You perform qualification of systems while interpreting standards according to specific cases in alignment with cGMP, cGLP, and internal procedures.
• You ensure that the qualified status of systems remains compliant with cGMP at all times.
• You support projects by adhering to all required cGMP regulatory standards.
• You keep up-to-date on emerging validation regulations and testing practices to not only meet but exceed cGMP requirements.
• You are responsible for validation documentation throughout its approval and implementation phases.
• You provide input in reviewing and assessing changes to determine their impact on qualified status and validation documentation.

Join a dynamic pharmaceutical environment where your skills will contribute to ensuring the highest standards of safety and quality at a state-of-the-art manufacturing site. We seek a dedicated professional who is passionate about operations in the impactful field of pharmaceuticals.

As an ideal candidate, you are an experienced Cleaning Validation Specialist who thrives in a fast-paced environment and enjoys working collaboratively across teams. If you are detail-oriented, technically proficient, and motivated by challenges, this opportunity might be perfect for you.

• You participate in functional meetings essential for executing the scope of responsibilities.
• You prepare to work primarily during day shifts, with occasional early/late shifts as needed.
• You ensure consistent execution of the assignment despite absences due to holidays, training, or other reasons.
• You perform periodic reviews of cleaning processes in three production departments to maintain their validated state.
• You coordinate and execute annual re-qualification studies within designated IPTs.
• You support cleaning projects by developing and validating various cleaning methods.
• You handle deviations, conduct root cause analysis, and address audit gaps.

Join a forward-thinking organization committed to maintaining excellence in quality assurance within the dynamic landscape of the pharmaceutical industry. Our client seeks a dedicated professional eager to contribute significantly to system qualification processes and ensure compliance with rigorous regulations.

As an ideal candidate, you are a knowledgeable QA Engineer with a strong background in quality standards and an unwavering commitment to safety and compliance. If you are someone who thrives in detail-oriented environments and embraces opportunities for continuous improvement, this position could be your next career move.

• You integrate quality standards to mitigate failure mode risks during risk-based assessments in asset management design reviews.
• You ensure the compliance of qualification activities and review and approve qualification documents.
• You approve calibration and maintenance records and certification master data.
• You review change control records and quality issue investigations, ensuring all corrective actions are implemented.
• You maintain knowledge of international regulations and industry practices related to system qualification.
• You prepare for regulatory inspections and act as a spokesperson for QA qualification during audits.
• You collaborate with cross-functional teams to ensure timelines for system qualifications are met.

Join a vibrant team dedicated to enhancing efficiency in the highly regulated pharmaceutical industry. This role offers a variety of challenges and opportunities for professional growth in a supportive environment.

As an ideal candidate, you are a proactive Material Life Cycle Management Specialist with a blend of technical knowledge and excellent communication skills, ready to take on diverse tasks while ensuring compliance and operational excellence.

• You onboard and maintain new materials and services effectively.
• You research and align local procedures to meet internal and external compliance standards.
• You ensure business continuity by maintaining timely availability of alternatives for production planning.
• You identify significant cost items and propose cost-reduction strategies without compromising quality or supply.
• You set up and optimize processes, data, and systems for operational excellence.
• You support various projects, including the Transfer Out initiative.

Join a forward-thinking team dedicated to revolutionizing biopharmaceutical manufacturing. This opportunity involves being at the forefront of analytical developments in the biotechnology sector, supporting the launch of new products and enhancing existing processes.

As the ideal candidate, you are a talented MSAT Scientist who is passionate about leveraging your analytical skills to drive innovation and support product quality in a collaborative environment.

• You develop, optimize, execute, and transfer liquid-chromatography coupled to mass spectrometry (LC-MS) methods.
• You act as an expert for analytical HPLC and mass spectrometry.
• You integrate characterization LC-MS data with process and product knowledge.
• You maintain end-to-end method responsibilities, from development to execution and documentation.
• You identify improvements for existing analytical methods to enhance technology, robustness, and efficiency.
• You provide investigational support for product and process development, including scientific/technical study generation and impact assessments.
• You support analytical activities related to product characterization and process improvements for late-stage development or commercial products.

Stap in een dynamische omgeving waar techniek en processen gecombineerd worden om uiterst betrouwbare resultaten te leveren. Deze rol biedt de kans om te werken met geavanceerde apparatuur en een belangrijke bijdrage te leveren aan operationele efficiëntie.

Als ideale kandidaat ben je een gedreven process technician die zowel mechanische als elektrische storingen kan oplossen en het onderhoud op zich neemt. Je hebt de kennis en ervaring om verbeteringen te identificeren en implementeren. Als je op zoek bent naar een rol waar je effect kunt hebben en jouw technische vaardigheden kunt toepassen, dan is deze functie iets voor jou.

• Je lost storingen zowel mechanisch als elektrisch zelfstandig op.
• Je voert preventieve en predictieve onderhoudswerkzaamheden uit.
• Je kalibreert meetinstrumenten volgens de gestelde procedures en methodes.
• Je zoekt actief naar en implementeert verbeteringen binnen de processen.
• Je past de procedures die tijdens het trainingsprogramma zijn geleerd toe in de praktijk.
• Je communiceert duidelijk met collega's binnen en buiten jouw afdeling.
• Je documenteert en rapporteert alle uitgevoerde werkzaamheden grondig.

Join a thriving environment focused on delivering high-impact projects within the pharmaceutical sector. We are seeking a dedicated professional ready to take on significant responsibilities in a rapidly growing team.

As an ideal candidate, you are a seasoned Project & Process Lead with extensive experience in process, utilities, and GMP standards. You have a strong commitment to excellence and possess the ability to manage complex projects efficiently.

• You lead project support from initiation through to handover, including engineering, tendering, construction, commissioning, and project control.
• You provide sub-lead support on larger projects by managing a subteam and/or a specific subscope.
• You conduct feasibility and engineering studies, ensuring alignment with contractors and internal engineers/SMEs.
• You facilitate communication and collaboration among team members to enhance project delivery.
• You ensure compliance with safety protocols and GMP standards throughout project lifecycle.
• You mentor junior team members, fostering their growth and understanding of project management best practices.
• You continuously evaluate project processes to identify and implement improvements.

Join an innovative biopharmaceutical manufacturing environment where your expertise will play a crucial role in enhancing treatment through therapeutic protein production. Our client is looking for a dedicated professional eager to be part of the digital transformation that will streamline laboratory operations.

As an ideal candidate, you are a skilled Consultant Process Engineer/Scientist who is passionate about integrating technology with scientific processes. If you thrive in laboratory settings and have a strong IT affinity, this role may be a perfect fit for you.

• You support the implementation of laboratory informatics and digital lab solutions.
• You utilize your knowledge in biotech process and analytical development to contribute to innovative solutions.
• You perform experiments involving mammalian cell growth in bioreactors and assist in protein purification.
• You collaborate with cross-functional teams to align on project goals and share findings.
• You actively engage in the digitalization initiatives by developing electronic notebook methods.
• You consistently analyze data to inform process improvements and efficiencies.
• You communicate effectively and build relationships across teams to achieve common objectives.