Job Openings | KOMMLINk

TOC Analytics Consultant - June 2026 - Ingelheim Am Rein, Ingelheim Am Rein

Fri, 29 May 2026 05:14:05 GMT

For one of our clients in the pharmaceutical sector, we are looking for a freelance TOC Analytics for Cleaning Verification and Process Assurance Consultant.

1. Project Name
Qualification, Establishment, and Validation of TOC Analytics for Cleaning Verification and Process Assurance in Pharmaceutical Production and Launch Operations
2. Project Description
The service is requested within the framework of the project “Qualification, Establishment, and Validation of TOC Analytics for Cleaning Verification and Process Assurance in Pharmaceutical Production and Launch Operations.”
The objective of the project is to provide, by the end of the year, a fully qualified TOC analytical system, including an SOP framework and validated method, as a regulatory-compliant, robust, and reproducible analytical platform that meets regulatory requirements (e.g., EU GMP, USP <643>, Ph. Eur. 2.2.44).
The project involves the establishment and qualification of a TOC measurement system (Total Organic Carbon) to support the analytical assurance of cleaning verification during product launches and the commissioning of a new production process for our client.
The project includes the methodological establishment and validation of TOC analytics for the determination of organic residual contamination (including active ingredients, excipients, and cleaning agents) in rinse and swab samples.
The goal is to enable a secure, controlled, and audit-ready routine operation of TOC analytics following successful qualification and validation.
3. Detailed Scope of Services
The external contractor will receive from our client in advance all necessary system access, templates, contact lists, requirements, documents, and any other information required to perform the work.
The service includes the following tasks, which are to be carried out independently by the external contractor:

Preparation and/or revision of GMP-compliant SOPs for the operation and maintenance of the TOC instrument, execution of TOC analytics, data handling, result evaluation, and deviation management
Technical consultation regarding the implementation of SOPs into routine laboratory operations
Independent execution of the qualification of the TOC measurement system (Shimadzu TOC-L) in accordance with GMP requirements
Preparation, review, and maintenance of the associated qualification documentation
Execution of method validation/verification according to internal requirements and regulatory guidelines, including but not limited to:
- Accuracy
- Precision
- Linearity
- Limit of quantification and limit of detection
- Specificity (blank/interference assessment)
- Robustness
- Including project-specific sampling procedures
Documentation of results in validation reports
Establishment of the TOC method for operational cleaning verification processes

The objective upon completion of the service is the availability of a fully qualified TOC measurement system as well as the provision of a validated analytical method for routine operations for our client.
4. Requirements

extensive knowledge in the establishment of TOC analytics, with ideally 3–5 years of professional experience in analytical chemistry, including project experience in the establishment and/or transfer of analytical methods.
Experience in the pharmaceutical sector is required, particularly in the area of cleaning validation and analytical methods supporting cleaning validation.

The candidate should have experience with the following software applications:

Shimadzu LabSolution TOC DB
Microsoft Office
Veeva Vault

The candidate should be familiar with and able to apply relevant regulatory standards and guidelines, including:

GMP
USP <643> / <645>
Data integrity principles and guidelines (e.g., ALCOA+)
strong expertise in analytical chemistry and regulatory requirements is essential.

International experience within a corporate structure is not mandatory for the initial local implementation phase but may be considered an advantage for future collaboration with global functions.
The candidate should be able to work effectively across relevant interfaces and departments and, where applicable, collaborate with other sites to ensure efficient knowledge sharing and exchange.

Start Date: 15/06/2026
Duration: Until 31/12/2026
Location: 30% Remote / 70% On-Site in Ingelheim am Rhein, Germany
Capacity: Full-time
Languages: Fluent German and English

Project Manager within Clinical Development and Operations - June 2026 - remote, remote

Fri, 29 May 2026 04:32:58 GMT

For one of our customers, we are looking for a Project Manager within Clinical Development and Operations

Project name: Trial Patient; Site Engagement

Project description:
The service is requested as part of the Patient and Site Engagement project within Clinical Development and Operations. The project’s purpose is the systematic collection, evaluation, and structured processing of insights from patients, caregivers, and trial sites to optimize Trial Design Outlines (TDO) and Clinical Trial Protocols (CTP)

Tasks:

Conceptual planning and methodological preparation of advisory board meetings to collect insights from patients, caregivers, and trial site staff for clinical trials in the planning stage.
Creation of formal recommendations based on gathered insights for the technical integration of learned solutions into Trial Design Outlines (TDO) and final Clinical Trial Protocols (CTP)
Methodological definition and structuring of technical requirements and frameworks to be used in structured interview projects/market research projects for external vendors to inform Trial Design
Outlines through gathering insights regarding the implementation of solutions into the TDO and CTP.
Independent consultation of trial teams regarding the definition of scope for these market research projects, the objectives, screeners, discussion guides including the technical review of vendor deliverables.
Preparation of structured summary decks regarding patient needs and preferences for delivery to the project responsibles.
Independent consultation of trial teams for the set up and implementation of Trial Patient and Site Engagement Plans for defined clinical trials
Quantitative and qualitative analysis of trial experience survey results across defined clinical trials for patients, caregivers, and sites, including the creation of final assessment reports.
The goal after completion of the service is the availability of the finalized insight documentation, compiled market research frameworks, draft Patient and Site Engagement Plans, and completed survey analysis reports.

Skills:

Seniority: minimum 2 years
Experience in pharma, in particular Clinical Development Operations is desired, but if they’ve worked for a vendor in this area that’s ok
It skills: Microsoft applications, Word, ppt. excel, Onenote, outlook
Bachelor’s Degree level necessary, Masters preferred
Experience in a corporate structure
Good English speaking and writing skills important

Location: remote
Start: ASAP
Duration: until 31.12.2026
Occupancy: 40 hours a week

Regulatory Analyst (REMIT II) - May 2026 - remote, remote

Mon, 04 May 2026 00:31:46 GMT

For one of our clients in the energy industry we are looking for a freelance Regulatory Analyst (REMIT II)

Project name: REMIT II implementation pre-study

Project description: the client, as a market participant in European commodity, gas and LNG trading, is subject to REMIT regulation and must prepare for upcoming REMIT II requirements. The current pre-study (May–June 2026) will assess the impact of EU implementation regulations and ACER guidance on our existing transactional reporting framework. This will be followed by implementation activities. The consultant (preferably a senior) advises the Regulatory Team on analyzing the impact of REMIT II, particularly regarding transactional reporting, and translates regulatory requirements into structured business and reporting requirements. Required

Tasks:

Technical analysis and interpretation of REMIT II requirements (EU regulation and ACER guidelines) regarding their impact on client’s current transactional reporting infrastructure
Creation of an impact assessment documentation on REMIT Transactional Reporting, specifically focusing on data fields, reporting logic, and interface compatibility within the existing trading and reporting processes
Identification of regulatory and technical overlaps with MAR, MiFID II and EMIR frameworks
Professional evaluation of regulatory developments and structured synopsis of relevant industry updates as a decision basis for the project team
Documentation of findings in a structured Bill of Requirements (BoR / BRD)
Provision of decision guidance to facilitate the alignment process between Legal, Trading, and IT stakeholders
Documentation of the pre-study results and handing over to client for final sign-off and further use

Required Skills:

Strong understanding of REMIT regulation (must-have)
Solid experience in transactional reporting (REMIT and/or EMIR strongly preferred)
Experience in regulatory reporting within energy or commodity trading environments
Good understanding of MAR, MiFID II, and EMIR (advantage)
Strong analytical and documentation skills Proven experience writing structured requirements (BoR/BRD)
Strong stakeholder management and communication skills across Legal, Trading, and IT.

Start: ASAP
Capacity: full-time, 40h/week
Duration: till 30.06.2026, after the pre-study, the consultant may also be able to continue in the next phase until mid-2027, provided all conditions are met.
Location: remote

Document Management Expert (SharePoint/Power Automate - 20 hours a week) - Epe, Epe

Wed, 29 Apr 2026 00:18:18 GMT

For one of our customers, we are looking for Document Management Expert (SharePoint/Power Automate - 20 hours a week)

Project Name: EPE Documentation Program

Project description: The documentation program at the Epe site serves the professional creation, maintenance and management of operating and plant documentation in accordance with the state of the art with the aim of permanently managing important technical documents and data as well as creating workflows and automations.

Service description:

Planning of documentation processes:

Professional planning and optimization of documentation processes and systems in the Epe plant on the basis of operating instructions and work processes of the company (provided in advance by the customer) with the aim of constructing these processes based on the work processes (maintenance schedule, commissioning of equipment).

Creation and maintenance of technical documentation:

Creation of new documents as well as updating of existing documents in the company's document repository with regard to the correctness and completeness of the information and the assigned metadata, as well as on the basis of the project requirements and technical requirements of the plant.

Development and implementation of documentation guidelines:

Develop standards for creating, structuring and managing documents, taking into account the information provided by the operational staff.
Professional summary of the results in a "documentation manual" as a technical guideline for suppliers and employees with the aim of a consistent and efficient documentation practice.

Organization and structuring of technical documents:

Technical implementation of systems and processes (operating and technical plant documents in the company's document repository) for the organization and structuring of documents with the aim of optimizing findability and accessibility on the basis of an independent analysis of user requirements.

Training and consulting:

Creation of a user manual and training material in the form of PowerPoint.
Conducting professional training of employees after the introduction of changes and new processes (face-to-face and online meetings) regarding documentation policies and processes, as well as professional and technical advice on documentation issues.

Optimization and customization:

Systematic evaluation of user feedback on the effectiveness of the documentation processes and optimization as well as the technical adaptation of the documentation processes (entry, numbering, versioning, automation).
Expert advice to the responsible departments of other companies and central functions for the harmonization of procedures, development and introduction of uniform standards and further development of document management.
Structured preparation of all results, guidelines and training documents for handover to customers for final approval and further use.

Must have:

Relevant training (e.g. technical administration, information services)
Additional training in the field of document management or information management is an advantage
Experience in a similar role, preferably in an industrial or technical environment
Good to very good MS Office skills
Very good knowledge of SharePoint
Fluent German

Nice to have:

English language skills
Meta-information: document management, information processes, technical data, optimization, management concepts, digitalization, innovation, project documentation
Knowledge of Power Automate is an advantage
Knowledge of AutoCad and/or E-plan is an advantage

Location: 95% on site (48599 Epe). Home office possible from time to time
Start: 01.06.2026
Duration: until 31.05.2028
Occupancy: 20 hours a week

Veeva Vault Specialist with a focus on Quality - June 2026 - remote, remote

Fri, 24 Apr 2026 08:46:45 GMT

For one of our clients in the pharma industry, we are looking for a freelance Veeva Vault Specialist with a focus on Quality

Overview:
The objective of this project is the digital transformation of the Quality Medicine landscape through the optimization and technical operation of a global Veeva Vault Quality environment. The goal is to establish and maintain stable, user-friendly, and GxP-compliant quality processes within an international, interdisciplinary framework. This initiative aims to bridge the gap between functional business requirements and technical system implementation, ensuring sustainable and compliant digital quality solutions that support global healthcare improvements.

Tasks:

Technical configuration of Veeva Vault Quality modules, specifically QMS, Training, and Quality Events, utilizing existing system standards to implement defined use cases.
Creation of Technical specifications derived from the independent assessment of business requirements provided by functional stakeholders via e-mail, and reviewing said technical parameters with defined architectural standards. The review will be documented in SharePoint
Technical Implementation of GxP compliance measures, including the independent preparation of validation documentation and the execution of technical change and release management steps in Veeva Vault.
Technical configuration of the Veeva Vault landscape, encompassing the deployment of new configurations, execution of data changes, and environment management within the Veeva platform.
Incident and problem management through the technical investigation and resolution of system errors. Issues will be raised via a Jira or Git Ticket-
Analysis of technical dependencies and cross-system impacts for configuration changes, based on a review of the existing system landscape and integration architecture to prevent technical regressions. Review will be documented in SharePoint.
Digital implementation of Quality Management System (QMS) processes for global application, translating process excellence goals into functional digital quality solutions within the Veeva environment.
Creation of documentation using Veeva Vault internal documentation tools and MS Office, using all system modifications and recording this according to GxP standards.
Handover of all documentation, results, reports and related deliverables to Boehringer for review, approval and for further usage.

Tasks:

Configure and maintain Veeva Vault Quality modules (e.g. QMS, Training, Quality Events),for clearly defined use cases following existing standards and guidance
Analyze business requirements from functional stakeholders and translate them into technical specifications in alignment with client standards
Contribute as a member of an agile product team (BUIZ AND IT), participating in refinement, sprint planning, testing and documentation
Ensure GxP and audit compliance, including support for validation documentation, change and release management
Support system lead activities, including deployment of new configurations, data changes, environment management, as well as incident and problem management

Requirements:

Bachelor’s or Master’s degree in Computer Science or a related or equivalent discipline
Handson experience with Veeva Vault or comparable platforms (e.g. Salesforcebased systems) combined with a good understanding of quality processes, such as deviations, CAPA, audits, supplier quality and training
Basic technical understanding of system landscapes, application roles and integration concepts including the ability to recognize and address technical dependencies and crosssystem impacts of configuration changes
Experience in the pharmaceutical industry or regulated environments (GxP including documentation and change/release processes) and agile ways of working is a plus.
Strong willingness to learn and grow beyond a single role, paired with excellent communication and teamwork skills in an international, interdisciplinary environment.

Location: 100% Remote
Start: 01.06.2026
Duration: till end of 2026
Capacity: 40 hours per week

OpenSearch Consultant - May 2026 - Remote, Remote

Tue, 21 Apr 2026 07:13:56 GMT

For one of our clients in the fashion industry, we are looking for a freelance OpenSearch Consultant – May 2026

Overview:

Creation of an in-house solution for on-site search along with a Merchandising UI.
The project aims to replace the current keyword-driven external solution for on-site search with an AI-driven solution featuring semantic understanding and personalization capabilities.
The services mentioned in point 3 will be delivered within the framework of the agile development method Scrum.

Background:
The company is developing a next-generation, AI-driven on-site search and PLP-ranking capability. Several critical elements require specialized expertise in:

OpenSearch relevance engineering
Multimodal product embeddings
Semantic search optimization
Personalization models
LLM-based query processing
Hybrid lexical/semantic retrieval
Multilingual search infrastructure

This expertise is not available internally. The contractor therefore provides a unique contribution with responsibilities significantly different from internal staff.

Tasks:

Technical consultation, configuration, and optimization of OpenSearch-based search relevance components, including analyzers, scoring parameters, hybrid retrieval structures, and vector-search integrations.
Development and refinement of retrieval and ranking models, including multi-stage ranking approaches, learning-to-rank concepts, and integration of relevance, behavioral, and business signals into ranking pipelines.
Creation of multilingual NLP components for various locales (LAM, EU, NAM), including tokenization, stemming, normalization, and locale-specific linguistic processing within OpenSearch and related pipelines.
Design and implementation of query understanding mechanisms, including synonym and concept extraction based on catalog and interaction data, query intent interpretation methods, and term/concept expansion techniques.
Development of LLM-enhanced search components, including prompt construction and incorporation of LLM-derived semantic signals into retrieval and ranking logic.
Creation of personalization logic for search and PLP ranking, including re-ranking frameworks balancing user affinity, semantic relevance, and commercial parameters.
Development and validation of autocomplete, spelling correction, and search suggestion components, ensuring robust multilingual handling and adherence to domain-specific terminology.
Definition and refinement of commercial relevance models, including recency-weighted popularity signals, interaction-based relevance indicators, and business-driven ranking adjustments.
Construction of evaluation and diagnostic frameworks for relevance quality using offline IR metrics and analytical assessment methods.
Modeling and integration of real-time or near-real-time data signals (e.g., stock levels, size availability) into filtering, faceting, and ranking components.
Technical implementation of data-science-driven backend logic for the Merchandising UI, including scoring routines, rule evaluation structures, configurable business logic, and interfaces for merchandising adjustments to search and ranking behavior

Location: 100% Remote
Start: 11.05.2026
Duration: till 31/12/2026
Capacity: ~36 hours per week

Scala/Java Developer - May 2026 - remote, remote

Thu, 16 Apr 2026 01:33:23 GMT

For one of our clients in the energy industry, we are looking for a freelance Scala/Java Developer

Project Name: PricingEngine Modernization

Project Description: The purpose of the project is to modernize the existing PricingEngine application in order to enable future operationality.

Tasks:

Technical implementation of the upgrade of the PricingEngine from Scala 2.12 to Scala 3.3.7 LTS and Java 8 to Java 21 LTS, including the independent architectural conversion of Maven to an SBT multi-project structure.
Technical evaluation and implementation of necessary version adjustments of existing Libraries and dependencies in the course of the Java/Scala upgrade, taking into account the project goals and requirements provided by client in advance.
Technical preparation of a technical documentation of the modernization measures carried out and handover to client for approval.
Technical code restructuring of the PricingEngine into independent, individually compilable modules based on the module structure defined in advance by the client
Independent conceptual design and Technical modernization of the Azure build pipelines (DevOps) to optimize the deployment processes and documentation of the results for handover to client
Technical analysis and technical implementation of security optimizations in the area of cyber security using the monitoring tools provided by client (DevSecOps via Snyk).
Professional presentation of the significant changes and technical improvements achieved in the course of weekly online meetings for approval by the client

Required skills:

English
Extensive Scala and Java knowledge

Nice to have:

SBT
Maven
Git
DevOps.
German

Location: remote, approx. 1- 2x a month project meeting on site (Dusseldorf)
Capacity: 32h/week
Start: 04.05.2026
Duration: till 30.09.2026 (extensions possible)

Comms Campaign Project Manager for pharma - March 2026 - remote/Ingelheim, remote/Ingelheim

Tue, 24 Feb 2026 04:22:46 GMT

For one of our customers we are looking for a freelance Comms Campaign Project Manager for pharma

Project name: ILD Care

Project description:
Strengthening the health literacy of patients with existing or potential pulmonary fibrosis through the implementation of regional awareness measures and structured patient counseling at 24 locations in Germany. This includes building partnerships with pulmonary fibrosis centres, patient organisations and regional stakeholders, leveraging existing contacts to promote sustainable patient education.

Tasks:

Creation of a detailed project plan using MS Project or Excel, including definition of project phases, time series and deliverables for all project phases.
Development and development of a risk assessment as well as a risk register in Excel for the identification and independent evaluation of project consequences.
Creation of a communication plan to define information flows.
Generate regular digital project status reports in PowerPoint to show the current level of progress.
Logging of project-relevant deadlines.
Preparation of a comprehensive project final report in Word or PDF after completion of the measures.

Implementation of mobile awareness and counselling missions

Detailed scheduling and content conception of the 12 site-specific consultation days.
Detailed planning of all organizational parameters such as location selection, schedules, material logistics and time management.
Operational implementation of the consultation days at the respective locations.
Documentation of the implementation and the results achieved per location in Word or Excel.
Definition of consulting formats (one-day face-to-face workshops or structured 1:1 on-site consulting appointments) based on the contractor's technical expertise.

Identification and involvement of external stakeholders

Identification of relevant regional ILD centres, rehabilitation facilities, patient organisations, medical experts and local self-help groups.
Initial approach of the identified stakeholders to present the project and determine their willingness to participate.
Documentation of feedback and contact details in an Excel database.
Creation of a recommendation list for strategic stakeholder involvement in PDF or PowerPoint.

Evaluation of ILD Patient Materials

Revision of the content and language of the materials, taking into account accessibility criteria.
Adaptation of existing information materials and creation of new ones using Adobe InDesign, Word or PDF.
Derivation of suitable communication channels for the materials produced.
Creation of a change log in Excel to track the adjustments made.

Planning regional online awareness campaigns

Definition of target groups and selection of suitable online channels (social media, specialist portals).
Development of a media plan including budget recommendations in Excel.
Creation of a content plan (formats, messages, schedule) in Word or PowerPoint.
Definition of campaign KPIs to measure campaign performance and digital success.
Provision of the final digital advertising material as well as preparation of interim and final reports on the course of the campaign.

KPI tracking and outcome reporting

Development of a standardized tracking system in Excel or Power BI for independent performance measurement.
Analysis of the results of all deployments and campaigns based on the defined KPIs.
Derivation of technical findings and recommendations for action.
Creation of regular outcome reports as well as an overall evaluation at the end of the project in PDF or PowerPoint format.

Required skills:

Professional experience: At least 2 years of relevant project experience.
Industry knowledge (pharmaceuticals): Experience in the pharmaceutical sector is strongly preferred. Ideally, candidates have at least 2 years of experience in one or more of the following areas:
- Medical Science Liaison (MSL)
- Patient engagement
- Sales / Key Account Management
- PR & Communications
Indications:
- Strongly preferred: Pneumology
- Also preferred: Specialty Care

Software & Qualifications:

A confident handling of MS Office (especially PowerPoint) is required.
Formal project management certifications (such as PMP/PPM) are not a must, but strong, field-proven project management skills are required.
A basic understanding of medicine (e.g. through a scientific degree or training as a pharmaceutical sales representative) is a clear advantage.

Language skills:

German: Fluent in negotiation (required).
English: Good knowledge (preferred).

General conditions:

International experience is a plus, but not a requirement. The candidates are fully integrated into the client IT structure (including external e-mail address). Budget responsibility from previous projects is not necessary.

Start: 16.03.2026
Workload: 25 hours a week (there is flexibility here, can be either increased or decreased)
Duration: until 31.12.2027
Location: 70% remote, 30% onsite (Ingelheim am Rhein)