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 leading automotive supplier is seeking an experienced quality expert for the inspection of weld seams on safety-critical body components. The project includes ensuring the highest quality standards through non-destructive testing methods. - Typical tasks: Independent planning, execution and evaluation of non-destructive tests (NDT), in particular visual testing (VT) and ultrasonic testing (UT). Creation and management of test plans and work instructions. Detailed documentation of test results in CAQ systems. Analysis of defect patterns and initiation of corrective actions in close coordination with welding shop and production planning. Calibration and maintenance of testing equipment. - Relevant technologies/tools: Ultrasonic testing devices, endoscopes, videoscopes, CAQ software (e.g. Babtec, QSYS), knowledge of standards DIN EN ISO 9712, ISO 5817, as well as relevant VDA volumes. - KPIs/success metrics: First Pass Yield (FPY) > 98%, reduction of internal defect rate (PPM), zero-defect tolerance on safety-critical seams (escape rate = 0), on-time completion of test orders. - Special challenges: Evaluating complex seam geometries under time pressure. Clear interpretation of test results and distinguishing between permissible irregularities and critical defects. Enforcing quality standards against production. - Deliverables: Completed test protocols, detailed defect analyses and reports, updated work and test instructions, contributions to FMEAs (Failure Mode and Effects Analysis). - Best practices: Regular team coordination (shopfloor management), continuous improvement of test processes (CIP), raising awareness and training of production staff.

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

## 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

We are seeking an experienced consultant for a process and project initiative in the area of Asset P&L (Profit and Loss) at a leading international financial services provider. - Typical areas of responsibility in this role:** - Analysis and documentation of existing end-to-end P&L processes for various asset classes (e.g., equities, fixed income, derivatives). - Identification of weaknesses, risks, and inefficiencies in data collection, processing, and reporting. - Design and conceptualization of optimized target processes for P&L calculation and attribution. - Development of functional specifications and business requirements for adapting or implementing IT systems (e.g., P&L engines, data warehouses). - Project management for the implementation of new processes and tools, including milestone planning, stakeholder management, and test coordination. - Development of control mechanisms to ensure data quality and consistency. - Creation of training materials and delivery of workshops for business units (trading, controlling, risk). - Relevant technologies, tools or methods:** - Advanced analytics: MS Excel (Pivot, Power Query, VBA), SQL. - Business intelligence: Tableau, Power BI, Qlik. - Project management: Jira, Confluence, MS Project. - ERP/finance systems: SAP FI/CO, Oracle Financials, or industry-specific asset management platforms. - Methods: Business Process Model and Notation (BPMN 2.0), agile project management (Scrum/Kanban). - Typical KPIs or success metrics:** - Reduction of P&L generation time (cycle time): target >25% efficiency gain. - Decrease in manual corrective postings: target >50% reduction through process automation. - Data quality index: increase of the "first-time-right" rate in data acquisition to >99%. - Efficiency ratio (cost-to-income): demonstrable positive impact on lowering the ratio. - User adoption rate: acceptance of new processes/tools by the business >80% after 3 months. - Key challenges, risks or specifics:** - Heterogeneous system landscapes and inconsistent data sources (data silos). - High complexity of financial products and valuation models. - Resistance to process changes in business units (change management). - Ensuring compliance with regulatory requirements (e.g., IFRS 9, BCBS 239). - Time- and budget-critical implementation during ongoing operations. - Concrete deliverables (“Deliverables”):** - Milestone 1: Completed as-is analysis and process documentation. - Deliverable 1: Detailed analysis report including assessment of weaknesses. - Milestone 2: Finalized target concept and Business Requirements Document. - Deliverable 2: Implementation roadmap and project plan. - Milestone 3: Successful User Acceptance Test (UAT) of the new process/tool. - Deliverable 3: Acceptance protocols, training materials, and project closure report.

A company is looking for an experienced Technical Project Manager in the field of district heating. The project objective is the planning and construction of district heating pipelines across all service phases of HOAI, as well as taking on complex project tasks. The Project Manager will play a key role in managing and coordinating projects, working closely with engineering firms, municipalities, authorities, and internal stakeholders. The role includes developing and optimizing planning options to maximize the efficiency and sustainability of projects. In addition, the Project Manager will continuously improve technical planning guidelines and processes, conduct technical-economic analyses, develop scenarios, and create concepts. Another focus is on budget planning for network investments in the heating sector, in close coordination with central controlling, as well as performing network calculations. - Planning and construction of district heating pipelines across all service phases of HOAI. - Management and coordination of projects in collaboration with engineering firms, municipalities, authorities, and internal stakeholders. - Development and optimization of planning options to increase efficiency and sustainability. - Support in improving technical planning guidelines and processes. - Conducting technical-economic analyses as well as developing scenarios and concepts. - Preparing budget planning for network investments in the heating sector. - Performing network calculations.

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

An EPC consultant is seeking an experienced Construction Manager (Mechanical) for the execution of a biogas plant. The goal of the project is the construction supervision and ensuring mechanical works are carried out in accordance with project requirements. In this role, you take responsibility for construction supervision and coordinate the mechanical works on site. You work closely with other project stakeholders to ensure compliance with schedules, quality standards and safety regulations. - Supervision of mechanical construction works at the biogas plant - Ensuring adherence to schedules and quality standards - Coordination of subcontractors and suppliers - Conducting regular site inspections and reporting - Assisting in resolving technical challenges on site - Compliance with safety regulations and environmental standards

Steering a strategic digitalization project in a hospital network, e.g. the implementation of a new HIS or an electronic patient record (ePA) in accordance with the KHZG. - **Typical areas of responsibility:** - Overall responsibility for project planning, control and monitoring (time, budget, quality). - Management of the interdisciplinary project team. - Requirements, risk and stakeholder management. - Planning and management of change management and rollouts. - Ensuring compliance with regulatory requirements (KHZG, GDPR). - **Relevant technologies, tools & methods:** - HIS systems (Orbis, iMedOne), ePA solutions. - Standards: HL7, FHIR. - Methods: PRINCE2, PMI/PMBOK, agile/hybrid. - Tools: MS Project, Jira, Confluence. - **Typical KPIs & success metrics:** - KHZG compliance, user adoption rate (>85%), process efficiency, milestone adherence. - **Key challenges & risks:** - High process complexity, intensive stakeholder management, interoperability, data security. - **Deliverables:** - Project plan, status reports, requirements specification, change concept, cutover plan, project closure report.

Within the scope of a digitization initiative, software quality is to be ensured and improved through modern testing, analysis, and review procedures. The goal is to increase development quality and efficiency through strategic measures and coaching. - Definition, monitoring, and improvement of test coverage strategies for critical software components. - Organization and execution of code reviews in compliance with coding standards, architectural, and security requirements. - Setup, execution, and evaluation of SonarQube analyses, as well as coordination of the remediation of technical debt and security vulnerabilities. - Training and support of developers in Clean Code, TDD, and CI/CD practices. - Evaluation and continuous further development of QA processes, tools, and metrics.

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

A company is looking for an experienced project manager with a civil engineering background for the power plant or energy industry. The aim of the project is to lead the planning, coordination and implementation of construction projects in the energy and power plant sector. The role requires close collaboration with interdisciplinary teams to ensure that projects are completed on time and within budget. It is explicitly stated that construction supervisors are not being sought. Main responsibilities: - Management and oversight of construction projects in the power plant or energy industry - Coordination between various disciplines and external partners - Ensuring compliance with safety and quality standards - Development and monitoring of project schedules and budgets - Identification and resolution of technical challenges - Reporting to stakeholders and management

- Construction management for the installation of electrical systems in the context of a grid connection project - Ensuring compliance with budget, schedule and quality objectives as well as all relevant legal regulations - Reviewing technical documents such as construction plans, material lists and performance records - Coordination and communication with subcontractors, suppliers and project stakeholders - Interface management and ensuring a smooth project process

A company is looking for a specialist site manager for electrical engineering as well as a specialist site manager for control engineering (Siemens T3000) for a demanding project. The aim of the project is the technical monitoring and control of the control system interfaces of the existing plant during the integration of the new plant, as well as ensuring quality and contract compliance during the construction and commissioning phase. The role requires intensive coordination and monitoring of interfaces with construction planning due to the size of the project. The site manager will work closely with control engineers, planners, experts and contractors to ensure the successful implementation of the project. Key responsibilities: - Technical monitoring of the control system interfaces of the existing plant during the integration of the new plant - Technical management of control engineers, planners, experts and contractors - Preparation of technical and project phase–dependent documentation - Participation in project meetings and negotiations - Technical management of quality assurance and quality control during the construction and commissioning phase - Consulting on control system commissioning - Technical coordination with design engineers on quality monitoring tasks - Monitoring contract compliance and conducting quality inspections - Participation in safety meetings and implementation of measures to address identified deficiencies

Typical tasks: - Analyzing existing insurance processes and identifying digitalization potentials - Gathering and documenting business requirements together with the business units - Creating solution concepts for digital transformation (including process modeling and cost-benefit analyses) - Acting as liaison between business and IT: translating requirements into technical concepts and supporting implementation - Supporting project management in planning and deploying new digital solutions (agile methods such as Scrum/Kanban) Relevant tools & technologies: BPMN modeling tools (e.g. Visio, Signavio), requirements management (Jira, Confluence), knowledge of common insurance IT systems, MS Office KPIs & metrics: adherence to project milestones and budgets, reduction of process lead times, increase in customer satisfaction/user adoption, reduction of manual efforts through automation Challenges: coordinating multiple stakeholders in the insurance environment (business units, IT, regulatory), integrating new digital solutions into existing legacy systems, dealing with regulatory requirements and data protection, change management and user adoption Deliverables: comprehensive requirements documents and process models, developed business concepts and user stories for IT implementation, defined implementation roadmap, training materials for updated processes Lessons learned: early involvement of all stakeholders facilitates the implementation of digitalization projects; iterative, agile approaches enable flexible adjustments; in-depth industry knowledge (products, regulation) is crucial for designing viable digital solutions

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.

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.

A traditional, medium-sized branded goods company in northern Germany is seeking a freelance consultant and FM expert for 6 to 9 months to reorganize business activities in Corporate Real Estate Management (CREM) and Facility Management (FM). - Typical tasks in this role:** - Analysis of existing FM and CREM structures, processes, and service contracts as part of the corporate reorganization. - Development of a forward-looking strategy for corporate real estate and facility management to support the new business objectives. - Optimization of space management (space efficiency, workplace concepts, repurposing) in line with "Future of Work" strategies. - Realignment of operational facility management: ensuring operational readiness of equipment and buildings, managing maintenance activities. - Consolidation and tendering of FM services; negotiation and management of service level agreements (SLAs). - Leading the internal FM team and managing external service providers. - Budget planning, control, and reporting to senior management. - Relevant technologies, tools or methods:** - CAFM / IWMS: Planon, ARCHIBUS, Spacewell, SAP RE-FX, PMWeb. - ERP systems: SAP S/4HANA, Oracle. - Project management: MS Project, Asana. - Office suite: MS Office / Google Workspace. - Methods: Benchmarking, SLA management, Life Cycle Cost Analysis (LCC). - Typical KPIs or success metrics:** - Reduction of operational FM costs per m² by >10% through process optimization and consolidation. - Increase in Planned Maintenance Percentage (PMP) to >80% to reduce reactive failures. - Improvement of SLA compliance by external service providers to >95%. - Reduction of asset downtime for critical infrastructure by >20%. - Successful achievement of defined reorganization milestones within time and budget. - Key challenges, risks or specifics:** - High resistance to change within the existing organization (change management). - Lack of transparency due to fragmented data and missing digital processes. - Complexity in renegotiating or terminating long-standing service provider contracts. - Ensuring operational continuity during restructuring. - Balancing cost reduction pressures with maintaining service quality and employee satisfaction. - Concrete deliverables:** - Milestone 1: Completion of the as-is analysis and presentation of results. - Deliverable 1: Detailed assessment report with SWOT analysis and benchmarking. - Milestone 2: Approval of the new FM/CREM strategy and target operating model. - Deliverable 2: Strategy paper, process map, and implementation roadmap. - Milestone 3: Successful completion of service provider tender(s). - Deliverable 3: Signed new service contracts and handover plan. - Final Deliverable: Handover documentation to subsequent line management.

A company is seeking support for carrying out the engineering for power generation and consumption facilities and their connection to the transmission and/or distribution grids of grid operators in Germany and abroad. The project includes both existing facilities and power plants, energy consumption and hybrid facilities under development, such as battery systems. The goal is to plan, coordinate and implement grid connections efficiently. Main tasks: - Managing approval processes for grid connections at the respective grid voltage level - Preparation of technical documents for grid connection requests - Creation of grid connection applications including technical documentation for grid operators - Technical engineering for grid connection concepts - Planning of high-voltage, medium-voltage switchgear and substations - Basic and detailed engineering including tender documents and specifications - Development of technical standards to implement quality requirements - Control and coordination tasks within project execution - Consulting and coordination of quality assurance measures - Project management considering technical regulations and project management strategies - Advice on contract management, e.g. grid connection agreements - Coordination of processes and execution of on-site construction supervision measures - Development of retrofit concepts for conventional power plants, hydropower plants and other facilities

Wir sind der Defense Tech Inkubator NRW – eine neue Initiative zur Förderung innovativer Startups im Bereich Verteidigungstechnologie. Unser Ziel: Die besten Köpfe und Technologien mit Industrie, öffentlichen Akteuren und Investoren vernetzen – und so nachhaltige Innovationen für sicherheitsrelevante Anwendungen ermöglichen. Zur Verstärkung unseres operativen Teams suchen wir eine erfahrene Persönlichkeit aus dem Bereich Verteidigung – idealerweise mit Erfahrung als Offizier der Bundeswehr oder durch langjährige Tätigkeit bei einem der führenden Systemhäuser (z. B. Rheinmetall, Hensoldt, MBDA etc.). 🛠 Deine Aufgaben: - Identifikation, Ansprache und Gewinnung potenzieller Partnerunternehmen (u. a. aus Industrie, Verteidigung und IT) - Aufbau und Pflege dieses Investorennetzwerks - Mitgestaltung unserer Finanzierungsstrategie für den Inkubator - Repräsentation des Inkubators auf Branchen-Events, Messen und in Netzwerken - Unterstützung beim Aufbau strategischer Allianzen auf Landes- und Bundesebene