
Semdor Pharma Group GmbH · Köln
DEINE AUFGABEN * Als Quality Manager suchst Du nach verantwortungsvollen Aufgaben und selbstständigen Arbeiten in einem offenen und ehrlichen Team. * Es m...
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WIR SUCHEN DICH Vulcan Energie Ressourcen GmbH ist ein innovatives, schnell wachsendes Unternehmen im Bereich nachhaltiger Lithiumgewinnung und erneuerbarer Energien. Mit unserer Lithiumanlage leisten wir einen entscheidenden Beitrag zur Dekarbonisierung der europäischen Industrie und zur Sicherung einer nachhaltigen Lithiumversorgung in Europa. Unterstütze unser engagiertes Team dabei, unsere Vision einer klimaneutralen Zukunft Wirklichkeit werden zu lassen. Für unser erfahrenes und strukturiertes HSEQ Team am Standort Karlsruhe suchen wir dich in Vollzeit (40 h) als Quality Manager Anlagenbau (m/w/d). DAS ERWARTET DICH BEI UNS * Du überwachst die Ausführungsqualität von unseren Kontraktoren und unterstützt die Bauleiter, Projektleiter sowie Bauteams bei der Qualitätssicherung in Landau und FFM-Höchst. * Du entwickelst und implementierst notwendige Dokumente wie Managementpläne, SOPs, Control-Pläne, usw., um Qualitätsmaßstäbe zu setzen. * Du erstellst, entwickelst und übermittelst Aufzeichnungen und Prüfergebnisse und veranlasst qualitätssichernde Maßnahmen. * Du arbeitest eng mit den internen Projektteams, dem Auftragnehmern und gegebenenfalls Nachunternehmern zusammen. DAS SOLLTEST DU MITBRINGEN * Du hast einen Abschluss oder eine vergleichbare Qualifikation im Bauingenieurwesen, Bauprojektmanagement, Qualitätsmanagement oder einem verwandten Bereich. * Du hast profunde Kenntnisse im Qualitätsmanagement (Fehlermanagement, Lieferantenmanagement, Qualitätssicherungsmethoden) idealerweise im Anlagenbau (Öl, Gas, Chemie, Pharma) oder Bau. * Du hast mehrere Jahre Erfahrung im Umgang mit großen Projekten, in der operativen Qualitätssicherung sowie als internen Qualitätsauditor. * Du hast Erfahrung in der Teamführung, arbeitest selbstständig und kommunizierst sehr gut. * Du hast gute Deutsch- und Englischkenntnisse (B2-Niveau oder höher). DAS BIETEN WIR DIR * 30 Tage Urlaub (auf Basis einer 5-Tage-Woche) sowie an Weihnachten und Silvester. * Onboarding-Programm „Vulcan Starter Days“. Unter anderem mit Kraftwerksbesuch und Führung durch unser Labor. * Sport- und Freizeitangebote - EGYM Wellpass mit 15,00€ inkl.USt. Eigenanteil im Monat, regelmäßige Firmenevents,Afterwork-Sportgruppen. * Betriebliche Altersvorsorge. * Corporate Benefits Plattform mit vielen attraktiven Rabattaktionen. * Mit mein EAP von INSITE erhältst du jederzeit vertrauliche und kostenfreie Unterstützung – für mehr Wohlbefinden im Job und im Alltag. WIR FREUEN UNS DICH KENNENZULERNEN! Neugierig geworden? Schicke uns einfach über das Bewerbungsformular deinen Lebenslauf und schreibe uns, warum du gerne Teil von Vulcan werden möchtest. Bei Fragen steht dir Carolin Martini (Talent Acquisition Specialist) unter cmartini@v-er.eu zur Verfügung.
IHRE AUFGABEN Engineering Design, Systems Integration, and Development * Lead and coordinate the integrated development of mechanical systems, ensuring alignment between mechanical, structural, and electrical/control disciplines. * Define mechanical system concepts, requirements, and performance criteria, coordinating detailed design development through internal teams and external engineering partners. * Define mechanical interface requirements and coordinate with civil and structural engineers regarding loads, tolerances, deflections, connection details, and installation constraints. * Evaluate mechanical designs against performance, safety, maintainability, and constructability requirements. * Review, technically verify, and validate supplier and external partner designs, calculations, and shop drawings for compliance with project requirements, interfaces, and constructability. * Act as the mechanical lead within project teams, providing guidance and technical direction. * Coordinate mechanical activities across internal disciplines and external partners. * Support the gradual build-up of an internal mechanical engineering capability, subject to workload and project pipeline. * Contribute to defining future workflows, role profiles, and interface standards for mechanical engineering. External Engineering & Supplier Coordination * Define mechanical system scopes, interfaces, deliverables, and performance requirements for outsourced engineering partners and suppliers. * Identify, evaluate, and recommend suitable external engineering offices, manufacturers, and technology partners. * Technically steer and coordinate external partners to ensure timely, compliant, and integrated design delivery. * Review, challenge, and verify externally produced calculations, drawings, and specifications. * Ensure all externally developed mechanical content is fully coordinated with architectural, structural, and electrical documentation. Collaboration and Coordination * Coordinate closely with structural, electrical, and automation teams to ensure all systems function as one integrated solution. * Manage interfaces with electrical and control systems, including automation, sensors, limit switches, safety interlocks, power supply, and cabling routes. * Act as the main technical point of contact for mechanical system integration with internal teams, clients, and external stakeholders. * Coordinate with suppliers, vendors, and subcontractors, addressing technical queries (RFIs), design changes, and interface issues. * Act as the primary mechanical systems interface between internal disciplines and external engineering partners. Installation Supervision and Site Support * Provide technical oversight and coordination of mechanical installation and assembly activities, ensuring adherence to approved designs, method statements, and safety requirements. * Support preparation and review of lifting plans, installation sequences, and alignment and tolerance verification procedures. * Perform QA/QC inspections, monitor workmanship quality, and manage punch lists and corrective actions. * Coordinate contractors and site teams to ensure installation activities are completed safely, efficiently, and in accordance with project schedules. Commissioning, Testing, and Handover * Support commissioning activities, including functional testing, load testing (where applicable), and safety validation of movable systems in coordination with suppliers and specialist partners. * Ensure proper documentation of test results, approvals, and compliance checks. * Prepare and review handover documentation, including operation and maintenance manuals, as-built drawings, and training materials. * Support client and operator training during handover phases. Quality Assurance, Compliance, and Reporting * Ensure all mechanical systems comply with applicable standards, regulations, safety requirements, and client specifications. * Produce clear and structured technical documentation and reports for internal teams and clients. * Maintain traceability of design decisions, changes, and approvals throughout the project lifecycle. IHR PROFIL Required Skills and Experience * Solid mechanical engineering fundamentals with practical understanding of moving structures, drives, and electromechanical systems. * Proven ability to coordinate, integrate, and technically validate mechanical systems delivered by external specialists. * Proven site experience supervising installation and assembly works, including contractor coordination and quality control. * Ability to assess mechanical designs with respect to performance, safety, maintainability, and constructability. * Strong communication skills and ability to produce clear technical documentation and reports. * Confidence in reviewing, questioning, and verifying third-party engineering outputs without being the primary specialist designer. Preferred / Nice to Have * Experience with retractable roofs, movable bridges, large doors or gates, cranes and hoists, automated industrial systems, or similar heavy mechanical installations. * Knowledge of automation and control system integration, including PLC concepts, sensors, interlocks, and fail-safe design principles. * Familiarity with relevant engineering standards and safety practices, including machine safety, lifting and rigging coordination, and QA/QC processes. * Arabic and/or English proficiency, with the ability to work in international project environments and with global suppliers. Typical Professional Education / Certifications * BSc or MSc in Mechanical Engineering, Mechatronics, or Industrial Engineering with a strong mechanical focus. * Preferred: specialization or proven experience in machine design, mechatronics integration, heavy machinery, or structural–mechanical interfaces. Typical Additional Certifications (Optional but Valuable) * Project leadership or project management training (PM fundamentals; PMP or PRINCE2 beneficial for senior roles). * Machine safety or functional safety awareness (e.g., risk assessment, interlocks; TÜV or IEC-related exposure advantageous where applicable). * Site supervision or construction safety (HSE) certification. * Vendor or industry training related to drives, hydraulics, gearboxes, bearings, and automation systems.
Bioptimus is building the first universal AI foundation model for biology to fuel breakthrough discoveries and accelerate innovation in biomedicine. With more than $75M in funding, Bioptimus is a fast-growing start-up headquartered in Paris, incorporated in October 2023. Backed by leading international venture capitalists, our world-class team of scientists and engineers is redefining the frontiers of AI and life sciences. CLINICAL DATA MANAGER (SENIOR) Bioptimus’ mission is to accelerate biomedical innovation by building the reference foundation model of biology that will unlock AI superpowers for the biomedical ecosystem. As a well-funded and fast-growing start-up headquartered in Paris and incorporated in October 2023, we are growing a world-class team of scientists, engineers, and product leaders. This is a remote role. We’re headquartered in Paris, but the position can be performed remotely outside of Paris. ABOUT THE ROLE We are looking for a technical, execution-focused Clinical Data Manager to bridge the gap between unstructured, real-world data, and our frontier AI models. In this role, you will be the authority on clinical data structures, serving as the technical link during conversations with our global partners to standardise and harmonise data pipelines. Operating within our STELA program, you will structure our clinical datasets. You are a hands-on technical expert who writes reproducible code, enforces incoming data QC, and designs the data dictionaries and ontologies for our models. ABOUT THE STELA PROGRAM We recently launched the Spatial Tissue Embedding Learning Atlas (STELA)—a multinational spatial data generation initiative anchored by strategic partnerships with 10x Genomics and Broad Clinical Labs. STELA serves as the data backbone for M-Optimus, aiming to profile up to 100,000 patient specimens across three continents (US, Europe, and Asia). This will integrate high-resolution spatial transcriptomics, histopathology imaging, and longitudinal clinical records to bring forward the next era of biological AI and precision medicine. WHAT YOU'LL BE DOING ---------------------------------------------------------------------------------------------------------------------------------- As our Clinical Data Manager, you will operate at the intersection of data engineering, clinical science, and partner collaboration across two strategic domains: PARTNER DATA ENGINEERING & COLLABORATION * Technical Partner Interface: Participate directly in technical conversations with external partners (hospitals, research institutions, CROs/CMOs). Dive into the details of diverse clinical data structures to understand how data is captured, stored, and extracted. * Order from Uncertainty: Translate ambiguous source data into harmonized, AI-ready assets. * Ontology Integration: Map and align diverse clinical data to industry-standard biomedical ontologies (e.g., SNOMED, ICD, etc…) with an emphasis on clinical oncology and immunology data. DATA GOVERNANCE, QUALITY, AND AUTOMATION * Data Dictionary Architecture: Design, build, and maintain data dictionaries, schemas, and metadata models that align with STELA’s multimodal pipeline requirements, while ensuring integration with existing pipelines. * Enforcing Ingest Quality: Establish, automate, and enforce data quality control (QC) and validation frameworks to check incoming partner data for integrity, completeness, and programmatic consistency. * Reproducible Pipeline Code: Write production-grade Python code to automate data cleaning and harmonization tasks. CLINICAL REALITY & INTUITION * Clinical Reality: Practical understanding of how clinical data is generated in the real world (hospitals, trials, CROs). You understand the gaps between ideal protocols and messy clinical realities, and you know what red flags to look for in incoming data. * The Investigative Mindset: You know what questions to ask partners to get to the "ground truth" of their data structures. Actively audit data to find missing variables, anomalies, and hidden biases. * Oncology/Immunology Domain Knowledge: Familiarity with cancer progression metrics (e.g., RECIST criteria, TNM staging, longitudinal treatment lines like immunotherapy vs. chemotherapy) so you can recognize what data is important. WHAT YOU'LL BRING ---------------------------------------------------------------------------------------------------------------------------------- The successful candidate will have a ‘team-first’ attitude; be independent, curious, and detail-oriented; thrive in a dynamic, fast-paced environment; and be fun to work with. You possess the rare ability to confidently lead complex technical alignment meetings with partners while simultaneously being excited to roll up your sleeves and write code. TECHNICAL & PROFESSIONAL QUALIFICATIONS * Educational Background: Bachelor’s or Master’s degree in Life Sciences, Bioinformatics, Health Informatics, Computer Science, Statistics, or a related quantitative field. Equivalent practical industry experience is highly valued. * Industry Experience: A few years (typically 3–5+) of hands-on experience in clinical data management or clinical data engineering within a CRO, CMO, pharma, or biotech environment. Proven track record of taking messy partner data and building reproducible, production-grade workflows. * Hands-on Coding Skills: High proficiency in Python and standard data science libraries (e.g., Pandas, NumPy) for data manipulation, cleaning, and validation. * Software Best Practices: Demonstrated commitment to code reproducibility, including strong experience with Git version control and building reusable data pipelines. * Clinical Data Expertise: Familiarity with clinical data structures, electronic health records (EHR), case report forms (CRFs), and longitudinal clinical trial data. * Ontologies & Vocabularies: Knowledge of standard clinical and biological ontologies, specifically those tailored to cancer/oncology and/or immunology datasets. PARTNERSHIP & EXECUTION SKILLS * Communication & Alignment: Ability to align on data delivery formats with a partner clinical teams. * Start-up experience: Comfort working in a fast-paced startup environment where data schemas evolve and ingest requirements must be defined from scratch. HOW TO STAND OUT ---------------------------------------------------------------------------------------------------------------------------------- * Experience with cloud computing platforms (AWS, GCP, etc…) * Experience working directly with multimodal datasets (e.g., matching clinical records with omics or digital pathology imaging). * Understanding of CDISC standards (SDTM/ADaM) combined with a modern tech-stack approach (beyond legacy SAS programming). * Experience building or optimizing ETL pipelines for large-scale biobanks or multinational clinical consortia. THE CANDIDATE JOURNEY ---------------------------------------------------------------------------------------------------------------------------------- To be considered, please submit your CV in English. We believe in a transparent and collaborative interview process. Here is what you can expect after submitting your application: * Screening: A 30-minute introductory call with the Hiring Manager to discuss your background, motivations, and the position in more detail. * Interviews: Following a successful screening, you will be invited to a series of interviews: 1. Data Strategy Panel Presentation (45 min): You will present a short overview of a past data management challenge you overcame (e.g., designing a complex data dictionary or aligning messy CRO data), followed by Q&A. 2. Technical Deep Dive (30 min) - There will be 1 additional break out session to do a deep dive with 1-2 Bioptimus Engineers 3. Executive Interview (30 min): A discussion with member(s) of our Senior Leadership focusing on long-term vision, cultural fit, and mutual potential. * Offer: Following the completion of all interviews, our hiring team will make a final decision. Please note that an offer is contingent upon the successful completion of a reference check. * Onboarding: Welcome to the team! We will begin your onboarding to get you fully integrated at Bioptimus! WHY THIS IS A UNIQUE OPPORTUNITY ---------------------------------------------------------------------------------------------------------------------------------- * Join a mission-driven team redefining biology through AI. * Work in a collaborative, high-autonomy, high-impact environment. * Contribute to pioneering research, infrastructure, or strategy at the ground floor. * Competitive compensation, equity, and flexibility (remote options). * Help shape the scientific and technical culture of a category-defining company. ---------------------------------------------------------------------------------------------------------------------------------- We believe that the unique contributions of all Bioptimists create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, or disability status. Decisions related to hiring are made fairly, and we provide equal employment opportunities to all qualified candidates. We take responsibility for always striving to create an inclusive environment that makes every employee and candidate feel welcome.