A company is seeking an experienced engineering expert for sterile filling to support a challenging project in pharmaceutical production. The goal of the project is to optimize the efficiency and quality of filling processes and ensure compliance with all regulatory requirements. In this role, the expert will work closely with the internal team to develop technical solutions, analyze existing processes and implement improvements. Main Tasks: - Analysis and optimization of processes in sterile filling - Ensuring compliance with GMP and other regulatory requirements - Development and implementation of technical solutions for process improvement - Collaboration with interdisciplinary teams - Documentation and reporting of progress and results

For a large pharmaceutical company, an IMP (Investigational Medicinal Product) Quality Manager is sought to ensure GMP compliance and quality of investigational products. **Typical responsibilities in this role:** - Review and approval of manufacturing and batch protocols (Batch Records) for drug substance and drug product. - Execution of final quality release of investigational products for use in clinical trials. - Review and approval of GMP-relevant documents such as SOPs, validation reports, deviations and change control requests. - Creation and maintenance of product-specific quality agreements with internal and external partners. - Support for production and QC departments on all GMP-related questions and quality issues. - Planning and conducting internal audits and support during regulatory inspections and external audits. - Management and oversight of CAPA (Corrective and Preventive Actions) measures for sustainable problem resolution. **Relevant technologies, tools or methods:** - Quality management systems (QMS): Veeva Vault QMS, MasterControl, TrackWise, SAP QM. - Document Management Systems (DMS): Veeva Vault, OpenText Documentum. - ERP systems: SAP S/4HANA (especially QM module). - Laboratory Information Management Systems (LIMS). - Manufacturing Execution Systems (MES). - Methods: risk analysis (FMEA), root cause analysis (5 Whys, Ishikawa), statistical process control (SPC). **Typical KPIs or success metrics:** - Batch Release Time: average time from production completion to final release (target: < X days). - Right-First-Time Rate: percentage of batches released without deviations or rework (target: > 95%). - CAPA Effectiveness: reduction in recurrence rate of deviations after CAPA implementation (target: > 80%). - Audit Performance: number of critical/major findings in internal and external audits (target: 0). - Deviation Closure Rate: percentage of deviations closed within the defined timeframe (target: > 90%). **Key challenges, risks or specifics:** - High complexity and variability due to the development of new molecules and processes in the clinical phase. - Strict adherence to constantly evolving GMP regulations (e.g. EU Annex 1 for sterile products). - Ensuring product quality and patient safety under high time pressure (time-to-market). - Managing interfaces between development, manufacturing, QC, and regulatory affairs. - Risk of supply chain interruptions for critical raw materials or services. - Ensuring data integrity in all quality-relevant systems. **Concrete deliverables:** - Released batches of investigational products. - Approved master batch records and SOPs. - Completed and assessed deviation and change reports. - Audit and inspection reports with tracked action plans. - Valid quality agreements with all relevant partners. - Regular quality reports for management.

A company is looking for an Interim Head of Hr Country Services for Germany and Austria to cover a 13-month fixed-term contract while the current incumbent is on sabbatical leave. The role involves driving excellence in Hr service delivery, managing labour relations, overseeing local policies and compliance, and leading a team of Hr representatives and Health & Safety Officers. The position is based in Germany with flexible (hybrid) work arrangements and may require up to 15% domestic and international travel.- Drive labour relations strategy and manage relations with Works Council.- Set and deliver local reward strategy, including salary negotiations and benefits management.- Act as a mediator in employee-manager conflicts and recommend corrective actions.- Lead the HR Country Committee and advise leadership on employment matters.- Manage labour law issues, government audits, and represent the company in court if needed.- Ensure compliance with local regulations, privacy laws, and Group Policies.- Supervise HR Representatives and OHS Officers.-Support HR Business Partners in driving employee engagement actions.

Ein Unternehmen sucht einen erfahrenen Technischen Redakteur, der für die Erstellung und Verwaltung von Datenblättern, Produktbroschüren und Katalogen verantwortlich ist. Diese Dokumente sind entscheidend für den Vertrieb, rechtsverbindlich und Teil der internen Qualitätssicherung. Die Produktbroschüren präsentieren die wesentlichen Produktmerkmale und den Kundennutzen, während die Datenblätter detaillierte Spezifikationen enthalten. Die Rolle umfasst die eigenverantwortliche Steuerung und Überwachung sämtlicher Korrektur- und Abstimmprozesse bis zur finalen Freigabe sowie die Sicherstellung der definierten Qualitäts- und Freigabeprozesse gemäß den Unternehmensrichtlinien. Zudem ist die Ablage der finalen Daten in den entsprechenden Systemen wie Promo-Office-Datenbank, PDM und Internet-CMS erforderlich. - Erstellung von Datenblättern, Produktbroschüren und Katalogen gemäß den Vorgaben. - Aufbereitung der Daten für die Druckproduktion und ISO-konforme Ablage im Produktmanagement-System. - Steuerung der versionierten Dokumente für Druckproduktion und Veröffentlichung in Online-Medien. - Sicherstellung der definierten Qualitäts- und Freigabeprozesse. - Ablage der finalen Daten in den entsprechenden Systemen.

In assignment for a renowned client in the life sciences sector, a freelance support is sought in the area of Clinical Data Management. The main task is taking responsibility for coordinating all data management activities in clinical trials. - Typical responsibilities in this role:** - Creation and review of the Data Management Plan (DMP) and the Data Validation Plan (DVP). - Design and implementation of electronic case report forms (eCRFs) in EDC systems (Electronic Data Capture). - Coordination of data collection, validation, and cleaning throughout the study lifecycle. - Development and execution of query processes to resolve data inconsistencies with investigative sites. - Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug). - Conducting SAE reconciliation (matching serious adverse events). - Preparation and execution of database locks after data collection is complete. - Preparation of status reports and communication with the study team (project management, monitoring, biostatistics). - Relevant technologies, tools, or methods:** - EDC Systems: Medidata Rave, Oracle Clinical, Viedoc, Zelta, OpenClinica. - Programming/analysis tools: SAS, R, Python, SQL. - Standards: CDISC (SDTM, ADaM), GCP (Good Clinical Practice), 21 CFR Part 11. - Collaboration tools: MS Teams, Jira, Confluence. - Data visualization: Tableau, Power BI. - Typical KPIs or success metrics:** - Data quality: Query rate (number of queries per 1,000 data points) < X; data entry error rate < 1%. - Time management: Time from last patient last visit (LPLV) to database lock (target: 4–6 weeks). - Efficiency: Average time to query resolution (target: < 10 business days for critical queries). - Compliance: 100% adherence to DMP-defined milestones and processes. - Protocol adherence: Rate of protocol deviations related to data management < 5%. - Key challenges, risks, or specifics:** - Managing increasing volumes and sources of data (e.g., wearables, ePROs). - Ensuring data integrity and security (cybersecurity, data protection/GDPR). - Complexity due to mid-study changes (protocol amendments) and their impact on the database. - Ensuring consistent data quality across multiple global investigative sites. - Shortage of qualified specialists and high demands for onboarding in study-specific systems. - Concrete deliverables:** - Finalized and approved Data Management Plan (DMP). - Live and validated study database (EDC system). - Regular data cleaning reports and status updates. - Clean, quality-assured, and analysis-ready database. - Final locked study database with complete audit trail. - Archived project documentation after study close-out.

Ein Unternehmen sucht eine freiberufliche Unterstützung im Bereich HSE-Management / Sicherheitsfachkraft für ein langfristiges Projekt. Ziel des Projekts ist die Sicherstellung und Koordination der sicherheitstechnischen Maßnahmen auf einer Baustelle in Wiesbaden gemäß gesetzlichen und vertraglichen Vorgaben. Die Rolle umfasst die Verantwortung für die Umsetzung und Überwachung von Arbeitsschutzmaßnahmen, die Durchführung von Schulungen und Audits sowie die Erstellung und Pflege von HSE-Berichtswesen. Der HSE-Manager wird eng mit Kunden, Konsorten und Kontraktoren zusammenarbeiten, um die Einhaltung der Sicherheitsstandards zu gewährleisten. Key responsibilities: - Koordination der sicherheitstechnischen Maßnahmen auf der Baustelle gemäß §4 Arbeitsschutzgesetz - Abstimmung und Koordination der Arbeitsschutzmaßnahmen mit den Kontraktoren - Pflege und Aktualisierung des HSE-Site Manuals - Durchführung von Toolbox-Meetings - Teilnahme an Koordinationsgesprächen - Erstellung und Durchführung gewerke-bezogener Gefährdungsbeurteilungen - Regelmäßige Baustellenbegehungen inkl. Berichterstattung und Fotodokumentation - Meldung und Nachverfolgung von Mängeln sowie Ableitung geeigneter Maßnahmen - Durchführung von Schulungen und Unterweisungen im Bereich HSE - Überwachung der Nutzung persönlicher Schutzausrüstung - Organisation und Durchführung von HSE-Audits - Erstellung und Pflege des HSE-Berichtswesens - Prüfung relevanter Lieferantenunterlagen - Analyse von Arbeits- und Beinaheunfällen inkl. Präventionsmaßnahmen - Weisungsbefugnis gegenüber Kontraktoren in HSE-relevanten Themen

On behalf of a leading medical technology company, an experienced technical drafter or product designer is being sought to create and maintain technical documentation and design drawings. - **Typical responsibilities:** - Creation of standards-compliant 2D manufacturing drawings and 3D models of parts and assemblies using CAD software. - Detailing and dimensioning of designs, considering geometric and positional tolerances. - Creation and management of bills of materials and technical documents in the PDM/PLM system (e.g., SAP ECTR). - Implementation of revision services on existing drawings and documentation. - Close collaboration with the development and production departments to ensure manufacturability. - **Relevant technologies, tools or methods:** - CAD systems: Siemens NX, SolidWorks, CATIA V5, Autodesk Inventor (depending on client system) - PDM/PLM systems: SAP ECTR, Teamcenter, Windchill - Standards: thorough knowledge of relevant ISO and DIN standards for technical drawings, especially in regulated environments. - ERP systems: SAP S/4HANA - **Typical KPIs or success metrics:** - On-time delivery of drawings and documents. - Error rate in technical documentation (number of required correction loops). - Compliance with internal and external design and documentation standards. - Efficiency in implementing changes (throughput time). - **Key challenges, risks or specifics:** - High demands on accuracy and completeness of documentation due to strict regulatory requirements in medical technology (MDR). - Seamless traceability of changes (versioning). - Complexity of parts to be designed (e.g., freeform surfaces, complex assemblies). - Close coordination with various stakeholders (development, purchasing, quality assurance, production). - **Concrete deliverables:** - Approval-ready 2D manufacturing drawings and 3D CAD models. - Complete and released bills of materials in the ERP system. - Updated technical product documentation. - Change logs. - **Lessons learned/best practices:** - A clear and standardized template management significantly accelerates the creation process. - Regular alignment meetings with production can prevent costly errors early. - Careful maintenance of master data in the PDM/PLM system is the foundation for efficient collaboration.

A company is seeking support for a project aimed at transparently mapping the overall ordering process in the Portals area. The goal is to combine relevant data sources from order to activation to enable a holistic view of the end-to-end process. This should facilitate the identification of process deviations and optimization potentials. Key project milestones include connecting the required data sources, building self-service reports, and implementing automated alerts for deviations in the process flow. The challenge lies in the technical and professional integration of heterogeneous systems and data flows to ensure consistent monitoring and control of the ordering process. - Analysis and documentation of requirements in the Omnichannel area using requirements management tools and structured collection methods - Professional and technical analysis of existing data sources and ETL processes using database tools - Recording and evaluation of existing interfaces between source and target systems based on technical documentation - Consulting on technical integration of defined data sources into the Celonis environment considering the tools used (Celonis EMS, Data Pool and Data Push API) - Creation of technical queries and representations for process visualization based on provided platform functions (Celonis PQL, Studio) - Use of system-side functions for visualization and analysis of existing business processes (via Celonis Process Explorer) - Professional consulting on technical interfaces, data provision and systemic requirements

Ein Unternehmen sucht einen erfahrenen SAP ISU Experten mit spezifischem Fokus auf EEG-Billing. Ziel des Projekts ist die Optimierung und Weiterentwicklung von Prozessen im Bereich der EEG-Abrechnung innerhalb des SAP ISU Systems. In dieser Rolle wird der Experte eng mit internen Teams zusammenarbeiten, um sicherzustellen, dass die EEG-Billing-Prozesse effizient und regelkonform ablaufen. - Analyse und Optimierung bestehender EEG-Billing-Prozesse - Implementierung neuer Funktionen und Anpassungen im SAP ISU - Zusammenarbeit mit internen Stakeholdern zur Sicherstellung der Einhaltung gesetzlicher Vorgaben - Unterstützung bei der Fehlerbehebung und Systempflege - Dokumentation und Schulung der relevanten Teams

- A company is seeking an experienced interim procurement professional to support its Amsterdam office due to a departing colleague. - The role will end once a permanent successor is found, with the possibility of extension depending on the recruitment process. - The professional will act as the sole representative of a group-wide procurement organization in the Amsterdam office, working closely with a team of nine spread across Europe. - The role involves managing end-to-end procurement processes for both existing and new suppliers, focusing on Marketing and Professional Services categories. - The professional will ensure adherence to procurement standards, negotiate prices, and compare offers in collaboration with business owners. - The onboarding will primarily be remote, with occasional in-person days in Amsterdam.

The ProMi Squad (Process Mining) project aims to transparently map the end-to-end order process in the portals area. Relevant data sources from ordering to activation are consolidated for this purpose. The holistic view of the end-to-end process enables the identification of process deviations and optimization potentials. Key milestones of the project are the integration of the required data sources, the development of self-service reports, and the implementation of automated alerts for deviations in the process flow. The challenge lies in the technical and functional integration of heterogeneous systems and data streams to ensure consistent monitoring and control of the order process. ⸻ Service description - Analysis and documentation of requirements in the omnichannel area using requirements management tools and structured elicitation methods - Functional and technical analysis of existing data sources and ETL processes using database tools - Recording and evaluation of existing interfaces between source and target systems based on technical documentation - Consulting on the technical integration of defined data sources into the Celonis environment, taking into account the tools used (Celonis EMS, Data Pool, and Data Push API) - Creation of technical queries and representations for process visualization based on the provided platform functions (Celonis PQL, Studio) - Use of system functions for visualization and analysis of existing business processes (via the Celonis Process Explorer) - Functional consulting on technical interfaces, data provisioning, and system prerequisites

- Collaborate in the software development process in the field of process automation and word processing - 3rd level support - Participate in the analysis of software requirements in an agile development environment

- Customizing / parametrization of the core banking system according to the requirements of the business division - Maintaining ongoing operations - Initial and further training of internal staff

- IT project manager activities - Interface / bridging function between business domain and technology, hence the required compelling subject matter expertise.

For an external assignment at an end customer in the public sector, we are looking for your expertise in Fortigate/Fortinet. The project takes place within an existing operational environment, in the context of renewing the firewall or updating the firewall systems and security landscapes. Tasks - Configuration and operation of Fortinet products, particularly Fortigate firewalls - Integration into existing systems with many firewalls - Processing and implementation of firewall requests - Communication with internal units in data centers - Participation in patch days (quarterly)

A company is urgently seeking qualified commissioning engineers for an ongoing project at the Salzgitter site. The project’s objective is the commissioning and optimization of HVAC systems, ideally in the cleanroom sector. The role involves on-site work, shift work (periodically) and a 5-day work week. Main tasks: - Commissioning and optimization of HVAC systems - On-site work, including tasks on ladders, scaffolding and platforms - Coordination and organization of workflows - Communication with various project stakeholders - Ensuring compliance with technical standards and safety regulations

## Service Description without Personal Reference - **IT Project Management**: Creation of software rollout and migration plans for the bi-monthly releases of the MDOI application based on Blueplanet, taking into account all relevant dependencies using JIRA and stakeholder management - **Design Management**: Planning and creation of all relevant designs as well as their review in the Multi Domain Orchestration and Inventory (MDOI) tool for the Transport Networks sub-area, serving as implementation documentation of requirements using JIRA and Confluence - **Stakeholder Management**: Development and execution of communication measures regarding software changes based on the created designs, verification that the requirements are fully covered by the designs, including the preparation of documentation for management using Microsoft Outlook, Microsoft Teams, and JIRA

A company is looking for a creative POS designer who develops and implements innovative ideas for gastronomy areas. The project's goal is to increase visibility and brand presence through creative POS solutions. The focus is on developing and visualizing new concepts that comply with CI/CD requirements and brand guidelines. The role requires close collaboration with a large field sales team as well as small agencies and workshops. - Development of new POS ideas for gastronomy areas (e.g., back counters, bar solutions, illuminated logos, displays) - Visualization and presentation of creative approaches - Close collaboration with the field team (80 people in sales) - Support in POS marketing with a strong focus on visibility and brand presence - Implementation in compliance with CI/CD requirements and brand guidelines - Collaboration with small agencies or workshops for implementation

- Execution and processing of switching processes (supplier change, new registration, move-in/move-out) - Independent handling of clarification cases with analysis of rejection reasons and follow-up processing - Support in market communication as well as adjacent areas (e.g., meter reading, billing) at least at 2nd-level - Ensuring smooth workflows within energy industry processes

A company is looking for an experienced construction manager who specializes in pipe works. The goal of the project is to manage and supervise construction activities, particularly in the area of pipes with a diameter of DN2000. The construction manager will be responsible for planning, coordinating and carrying out pipe segment cutting operations. The position is entirely on-site in Düsseldorf. - Managing and supervising construction projects in the field of pipe works - Planning and execution of pipe segment cutting operations - Ensuring compliance with safety and quality standards - Coordination of teams and resources - Documentation and reporting on project progress