Jobsuche und Projektbörse für Fach- und Führungskräfte

Senior Expert Science & Technology – Functional Lead in Biologics – Global Drug Development (m/f/d)

Basel Stadt

Independently design, plan, organize and perform scientific experiments for the preparation and timely delivery of biologic drug products (DP), processes and procedures
Independently design, plan, organize and perform specific analytical tests related to the experiments as well as for related stability studies
Documentation of raw data from the scientific experiments including all conducted analytical tests as well as evaluation. interpretation and reporting of all results of the scientific experiments together with the project responsible (Functional Lead)
Interprets results including drawing relevant conclusions and delivers respective work packages to meet agreed objectives & timelines in the project team. Ensures and drives information exchange in DP sub-team
You will be a core member of the Drug Product development sub-team, representing the scientific and technical excellence and you might be a member of the CMC team ad-hoc if required
Based on the project status, participate in function-specific project sub team meetings and discussions
If required, support the compilation of scientific protocols / reports and lab procedures based on existing templates as well as contribute to compilation of SOPs
Take over responsibility for specific tools / equipment and utilize special tools / equipment or specialized facilities as an expert
Schedule and perform maintenance and qualification of tools / instruments / equipment as needed
Develop new methods or optimize existing laboratory methods/processes as well as contribute to development and implementation of new technologies

Online seit: Fri Aug 30 13:21:55 CEST 2024

Testmanager (m/f/d)

Freelance/Contracting project

North Rhine-Westphalia

Continuous improvement of software quality processes
Identification, documentation and reporting of quality defects
Promoting a proactive quality culture within the team
Participation in code reviews for early detection of quality issues
Develop effective testing strategies and perform manual and automated testing at various levels
Collaborate with various business teams to create relevant test cases
Executing test plans and scripts to validate software functionality
Understanding and familiarizing yourself with complex business processes and reducing process complexity
Supporting the team in the consideration of design and implementation decisions
Acting as a quality coach within the agile team
Analysis, troubleshooting and problem solving
Teamwork with developers
Use of collaboration and tracking tools (Azure, DevOps)

Online seit: Thu Aug 29 13:21:55 CEST 2024

Scientist Immunology and Cardiovascular/Metabolic Disease (LSW) - BS (m/f/d)

Freelance/temporary employment for a project

Basel Stadt

Carefully design, organize, and manage externally run studies in collaboration with internal scientists, procurement and contract research organizations in a timely manner
Act as an advisor for study design: Define scientific rationale, success metrics and monitor progress
Provide high quality analysis of conducted studies and summarize, present and discuss study results with project teams
Ensure excellent interaction with vendors and maintain overview on activities and capabilities of relevant CROs
Work on a flexible schedule to meet deadlines

Online seit: Tue Aug 27 11:29:41 CEST 2024

Senior Scientist Tech transfer (m/f/d)

Freelance/temporary employment for a project

Neuchatel

Responsible for supporting commercial manufacturing performance at the external manufacturing site
Represents MS&T external manufacturing team to provide technical support to the biological drug substance tech transfer process including deviation resolution, change management, delivery of yield targets and process optimization
Maintains strong working relationships with external and internal partner
Interface with internal functions such as MS&T, Quality, and Supply Chain
Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving
Tracks progress of routine manufacturing against schedule, provides routine updates and proactively identifies operational risks and remediation
Ensures timely escalation of potential technical, compliance or safety issues to the MS&T team and partners with internal MS&T resources to remediate
Ensures effective communication between technical transfer internal and external team
Support technology transfer activities as a primary duties
Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements

Online seit: Mon Aug 26 14:29:30 CEST 2024

QA Associate QMS (m/f/d)

Freelance/temporary employment for a project

Basel Stadt

Receives incoming documents e.g. executed batch records, work orders, vendor labels, packaging instructions etc.
Performs documentation in respective tools. Prepares documentation needed for the batch record review e.g. Analysis Reports, Specifications for clinical development, country label approval etc.
Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products
Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels, Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility e.g. CoC's, BRR Checklists
Scan, file and archive documents owned by QA e.g. Certificate of Compliance, Batch Record Review Checklists
Write and review procedures and forms related to the QA Batch record Review Process
Contributes to Right First Time performance reports for release of IMPs
Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes
Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes

Online seit: Mon Aug 26 09:40:22 CEST 2024

Biotechnologist (m/f/d)

Freelance/temporary employment for a project

Visp, Valais, Switzerland

Executes manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
Provides front line technical and procedural support, working with the manufacturing team.
Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements
Responsible for establishing timely and with high quality the required production documentation (preparation, execution and review of batch records) or other relevant GMP documents for the assigned production area.
Supports process related investigations and assists in decision making?on production issues
Supports process changes and CAPAs related to processes within required timelines
Performs training activities of relevant areas as operator and supports others and new joiners.
Operating, setting up and cleaning production equipment and premises for the production of liquid and freeze-dried drug forms (e.g.:compounding, parts washing, autoclaving, filter integrity testing, visual inspection)

Online seit: Fri Aug 23 16:57:39 CEST 2024

AWS Cloud Platform & Fullstack Developer (m/f/d)

Freelance/Contracting project

Baden-Wurttemberg

Development in Micro-Service-Architecture and Cloud-Architecture
AWS Cloud Development and CI/CD, ECS / Fargate, Lambda, Redis, CloudFront, S3, Route53, Github Actions
Development with Infrastructure as code tools, especially Terraform
Work on / built-up infrastructure and applications running in the cloud
Implementing backend applications and APIs
Handle API Management with Apigee
Refine features
Develop technical solutions based on defined requirements and user stories
Consult product owner and other ART stakeholder in solution design/ concepts
Develop/ code solutions
Perform code reviews
Support test concept development, end-to-end integration tests
Develop automated test routines
Document solutions

Online seit: Thu Aug 22 14:19:36 CEST 2024

Client Operations Onboarding, Maintenance, Quality Control Analyst (m/f/d)

Freelance/temporary employment for a project

Geneva

Process new account opening requests in a timely and efficient manner, with the highest standards of quality and care. Ensure the business is compliant with all Bank policies and global regulatory / legal requirements
Perform documentation updates for existing clients within the agreed timeframes
Enter data into various databases and check to ensure the accuracy of the data inputted
Perform quality reviews of new account openings and KYC periodic reviews in a timely and efficient manner, with the highest standards of quality and care
Prepare client KYC analyses, interacting with the Bankers to obtain KYC and other compliance information and documentation
Perform remediation exercises as requested, including remediation of digital and physical records
Follow up on all outstanding issues / escalations with relevant partners in the Bank including
Risk / Controls team and ensure a good relationship with key stakeholders to ensure the best client experience

Online seit: Thu Aug 22 14:16:05 CEST 2024

Expert Science & Technology (Analytical Lab Technician) (m/f/d)

Freelance/temporary employment for a project

Basel City

We are looking for a highly motivated laboratory expert with the focus on development and optimization of analytical methods to control and monitor chemical manufacturing processes and products
Plan and perform development of analytical methods in a non-GMP environment
Utilize obtained analytical methods to generate data on development samples and prepare the method for transfer to a GMP lab. The focus of this position is on Mixed Modality technologies such as Radioligand Therapies, Antibody Drug Conjugates and Oligonucleotides
A key activity includes also the maintenance all relevant lab infrastructure and supports order and housekeeping of chemicals and reagents required

Online seit: Wed Aug 21 16:18:41 CEST 2024

Senior Scientist Validation (m/f/d)

Freelance/temporary employment for a project

Neuchatel

Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs
Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
Establish and maintain the Validation Master Plan for process validation. Ensure that all manufacturing processes are validated, overview on state of validation at site is maintained.
Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation
Author or reviewer for routine validation protocols and reports, associated change controls and supports the execution at the shop floor
Develop the strategy for continued process verification that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews plans for CPV
Lead and drive investigation for validation related matters and implement corrective and preventive actions
Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards
Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency

Online seit: Wed Aug 21 16:05:05 CEST 2024

Laboratory Analyst / Lab Technician (m/f/d)

Freelance/temporary employment for a project

Neuchatel

Perform analytical chemistry testing that is required for release of drug products, stability samples and raw materials. Additional responsibilities may include support to analytical method transfers and validations, stability studies, revision of documents, handling of deviations and implementation of change controls
As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory
Performs analytical testing of solid oral drug products for release and stability testing, HPLC / UPLC, GC, UV/VIS, dissolution, etc.
Performs associated laboratory work preparation of solutions, waste disposal, etc.
Supports testing of raw materials according to pharmacopeia requirements
Performs peer review of analytical data
Respects EHS rules at all time
Respects 5S principles and proposes ideas for continuous improvement to lab processes
Can be assigned special tasks and project work

Online seit: Wed Aug 21 15:41:57 CEST 2024

SAP Consultant (m/f/d)

Freelance/temporary employment for a project

Winterthur

Verantwortung über SAP FICO 4 Hana-Module
Koordination von Tickets, Changes und Anfragen mit externen Partnern
Aufbau und Koordination der Infrastruktur für MM-/SD-Module
Dokumentation und Sicherstellung der Tracability von Changes
SAP-Optimierung in Zusammenarbeit mit externen Partnern
Erstellung von Reports und Analysen

Online seit: Wed Aug 21 11:24:42 CEST 2024

CQV Specialist (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

Involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others
Involved in the validation documentation including: URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ)
Prepare validation documents
Execution of IQ/OQ and PQ for equipment, systems and utilities
Write reports of completed validation activities. Work to identify efficiencies in the validation program approach
Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation
Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s
Write and/or revise procedures applicable to the Engineering activities
Support the Engineering group to prepare the validation, requalification, and maintenance program

Online seit: Fri Aug 16 17:00:18 CEST 2024

PT KM Expert Sinequa / Search specialist (m/f/d)

Freelance/temporary employment for a project

Basel Stadt

Indexing and Content Management: Collaborate with data source owners and application owners to ensure that all relevant content is properly indexed and searchable in the context of a specific use case. This involves understanding business requirements, setting up indexing rules, and ensuring accurate and efficient content retrieval
Issue Monitoring and Troubleshooting: Monitor the search platform for any issues or anomalies and provide timely resolutions. Troubleshoot and resolve search-related issues, working closely with cross-functional teams and vendors if needed
Documentation and Best Practices: Develop and maintain documentation and best practices for the search platform, including configuration settings, indexing guidelines, troubleshooting procedures, and performance optimization techniques
Maintenance and Optimization: Regularly maintain and optimize the Sinequa search platform, ensuring it is up-to-date and performing at its best. This includes monitoring system health, implementing necessary upgrades and patches, and configuring platform settings for optimal performance

Online seit: Wed Aug 14 11:21:03 CEST 2024

Electrical Lead Engineer (m/f/d)

Freelance/temporary employment for a project

Zurich

Requirements definition at electronics board level
Detailed design including trade-off, analysis, schematics capturing
Verification of electrical circuits by review, analysis and simulation
Coordination of Unit Interface Equipment (UIE) / EGSE definition and commissioning
Prototype and Flight electronics commissioning and testing
Assembly, Integration and Testing (AIT) support
Control and monitor the team mates in PCB/CCA domain
Ensure process adherence in the electronics development
Timely reporting/flagging to team leaders
Preliminary internal design reviews (schematics, layout, manufacturing files), checkpoint to release for project review teamEstablish and maintain engineering plans and activities schedules (e.g. in MS Project)
Coordination of a small team of development engineers

Online seit: Tue Aug 13 16:49:50 CEST 2024

EWM Consultant (m/f/d)

Freelance/Contracting project

Baden-Wurttemberg

Confirm outbound delivery (from EWM)
Communicate outbound delivery split (from EWM)
Post goods movement in ERP (from EWM)
Post goods movement with delivery reference in ERP (from EWM)

Online seit: Tue Aug 13 14:29:28 CEST 2024

Requirements & Test Engineer (m/f/d)

Freelance/temporary employment for a project

Geneva

You collaborate with the systems end users and other teams to understand business needs and functional specifications
You read and understand Functional System Requirements (FSRE) provided by the Business Analyst
You write, review, and update the Equipment Requirements (ERE) in collaboration with the Product Owner using Polarion and perform the traceability to the Functional System Requirements (FSRE)
You create and maintain the test cases to provide full coverage of Equipment Requirements (ERE) using Polarion
You write automatic test scripts for test automation environment. (Squish, Python)You execute manual and automatic tests in integrated validation environment as part of sprint work during the ild phase or as part of the SAT (Site Acceptance Test) during acceptance phase and report test results
You analyse and describe issues/bugs in the issues Database, and you participate in their classification
You act as point of contact to clarify identified defects or related Equipment Requirements (ERE)

Online seit: Mon Aug 12 18:44:32 CEST 2024

Adobe Solution Architect (m/f/d)

Freelance/Contracting project

Remote

Align requirements to Customers approved patterns and socialise these internally and with the requesting business units.
Solution Analysis and Change: Identify gaps in the existing patterns and provide options for meeting these through enhancements to the existing functionality supported
Support implementation teams with understanding solutions and troubleshooting any issues encountered in implementation.
Support PO / BA role in business Needs Identification: Engages with the business at an early stage to assess and define business needs. Drives reuse of existing capabilities over new / enhanced development.
Support BA / PO in creation of process flows, JIRA user stories, Tealium/ Veeva suggestion/ and tagging BRDs.
Creation and/or input into Standard Operating Procedures to ensure accuracy of documentation (Confluence).
Engagement with Global Commercial IT teams to deliver new capabilities and patterns to support evolving business requirements across AZ's application architecture.

Online seit: Fri Aug 09 11:35:05 CEST 2024

Data Link Expert (m/f/d)

Freelance/temporary employment for a project

Buchs

Identifying and configuring communication systems for unmanned aerial vehicles (UAV) to inspect oil pipelines
Obtaining necessary frequency licenses from authorities and ensuring uninterrupted communication between ground station and UAVs for longer distances
Modifying and testing communication and control systems based on market-available systems to fit specific needs
Conducting functional and operational tests on systems both domestically and internationally
Evaluating and analyzing collected data from inspections
Testing and root cause problem solving for hardware and software components
Hardware and software integration and specifcation of signal processing and automation in Areospace Avionics
Coordinate with network and data providers to ensure seamless operation of integrated systems
Plan and excute testing to validate system requirements and user experience
Collaborate with regulatory (e.g. FAA, EASA, ANAC) and industry organizations (e.g. ARINC, SITA) to stay informed and integrate new and advancing air-to-ground communication systems

Online seit: Thu Aug 08 12:10:56 CEST 2024

Senior Electronic and Firmware Development Engineer R&D (m/f/d)

Freelance/temporary employment for a project

Rotkreuz

Embedded software development for the modules (maintenance, bug fixing, implementing new features)
Electronic development from schematic design to system integration for new and existing instruments and technologies
Concept development of electronic modules (proactive proposals based on customer and service feedbacks)
Creation of technical specifications, design and verification documents according process from feasibility setup to the final unit
Perform and document feasibility studies and verification tests of instrument modules during development phase
Support of the product after launch during the whole life cycle of the instrument
Redesign of PCBs due to end of life and 2nd source topics
Migration of firmware code to new microcontroller platform
Code analysis of complex electronic modules and root cause analysis of field and production issues
Collaboration with experts of different disciplines, departments and external development partners as well as support less experienced developer

Online seit: Wed Jul 31 14:27:12 CEST 2024