CSV Specialist (m/f/x) | Köln/Bonn area | PharmaceuticalsAs a CSV Specialist (m/f/x) for this global pharmaceutical company, you will be responsible for the validation of computer systems within the engineering department. You will be part of a collaborative, exciting work environment and implement your expertise. These tasks are waiting for you:Ensuring the validated state of all GxP-relevant computerized systems in different areas in accordance with GMP regulationsValidation of computerized systems for new acquisitions and existing installationsProject management for computer system-related topics in projectsRecording and management of validation-relevant computerized systemsCreation and review of validation documentation and SOPs in the field of CSVConducting risk analysis and change managementTechnical collaboration in the development, optimization, and implementation of processes and projectsCooperation with interdisciplinary teams to ensure system integrity This completes your profile:Completed degree in Computer Science, Business Informatics, or a comparable technical fieldSeveral years of practical experience in Computer System Validation (CSV), ideally in the chemical industry or other regulated sectorsExperience in the validation and implementation of complex IT systems and software solutionsKnowledge of regulatory requirements (e.g., GMP) and strong familiarity with the GAMP5 guidelinesExcellent knowledge of IT architecture and relevant technologiesFluent German and good English skills, both written and spokenIndependent, analytical, and structured working style with strong problem-solving skills This is what the position offers:Interesting tasks with great potential for growthFlexible working hours in a 37,5h work week with 30 days holidayHybrid working modelOther benefits such as bike leasing, group accident insurance, affordable meals in the cafeteria, free employee parking Information about our client:Our client is a global pharmaceutical company dedicated to providing access to high-quality, affordable medicines. The company focuses on improving global healthcare by ensuring the availability of essential treatments for cardiovascular diseases, infectious diseases, oncology, and more.

SciPro are continuing to partner with an exciting, fast-growing global organisation who are on a mission to revolutionize healthcare, addressing unmet patient and consumer needs. We are supporting their search for an experienced individual to lead global regulatory strategies for their assigned product. As Director - Global Regulatory Lead, you will be responsible for shaping and executing regulatory strategies and play a key role in ensuring regulatory approvals, optimizing product labeling, and engaging with global regulatory authorities.Key Responsibilities:Develop and implement global regulatory strategies to support product approvals and labeling optimization.Lead the preparation of regulatory submissions, including briefing documents, IND dossiers, and CTAs.Manage communications and meetings with global regulatory agencies.Provide strategic regulatory guidance to cross-functional teams, ensuring compliance with global regulations.Key Requirements:Advanced scientific degree with significant experience in regulatory affairs.Strong communication skills, with the ability to simplify complex regulatory topics.Proven success in negotiating with global health authorities.If you're looking for a role where you can make an impact in a fast-evolving healthcare landscape, we'd love to hear from you.

We are seeking an experienced Senior IT Project Manager (m/f/x) to lead and drive digital transformation initiatives. You will be responsible for overseeing company-wide technology projects, ensuring successful execution, and aligning IT strategies with business objectives. You will have the opportunity to thrive in a dynamic biotech environment, adapting to evolving industry needs and regulatory requirements. These tasks are waiting for you: Lead end-to-end project management for digital transformation initiatives, including planning, execution, monitoring, and deliveryDevelop and maintain detailed project plans, timelines, budgets, and risk management strategiesCollaborate with business leaders, IT teams, and external vendors to define project scope, objectives, and deliverablesWork closely with third-party vendors to ensure project deliverables meet quality and timeline expectationsManage stakeholder communication, providing regular updatesDrive initiatives that contribute to measurable business improvements and successful project outcomesDetails about the workplace:Type of contract: indefinite + full timeVacation: 30 days / yearWorking hours: 40 hours / weekAn opportunity to lead the digital transformationA collaborative and inclusive work environment with a diverse team of expertsThis completes your profile:University degree in information technology, business or a related field, or equivalent qualification5-7 years of extensive experience with IT Project Management and strong understanding of methodologiesIdeally experience of working in a regulated environment (e.g., Pharma, MedTech, etc.)Effective communicator with a strong hands-on mentalityFluent in English; intermediate German skills are preferred Information about our client: Our client is a global clinical-stage biopharmaceutical company that discovers and develops drugs. With their innovation-driven team, the company focuses on vaccines, innovative cancer immunotherapies and protein-based therapies. If you are passionate about leveraging technology to transform businesses and have a track record of delivering complex IT projects, we'd love to hear from you!