Sökresultat för "Sterility Assurance"

SallyQ AB

We're looking for a passionate and driven Senior Manufacturing Scientist – Aseptic Processing to join our Manufacturing Science & Technology (MS&T) team in Uppsala and play a critical role in ensuring the robustness, compliance, and continuous improvement of our aseptic manufacturing processes. At Galderma, we're not just offering a job, we're inviting you to be part of something bigger. About the Role You serve as the site's subject matter expert for aseptic manufacturing and contamination control, providing scientific and technical leadership across critical aseptic operations. You work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement. A key part of the role is leading the site's media fill program and contamination control strategy, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements. Key Responsibilities Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes. Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance. Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices. Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes. Design and evaluate smoke studies to verify airflow performance and first-air protection. Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You're a curious, proactive, and scientifically minded professional who enjoys solving complex challenges and driving improvement in highly regulated manufacturing environments. You take ownership naturally, influence stakeholders with confidence, and navigate complexity while keeping compliance and continuous improvement front of mind. Qualifications Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment. Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations. Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing. Proven track record leading deviation investigations, root cause analyses, and CAPA implementation. Excellent analytical, problem-solving, and technical writing skills. Strong stakeholder management and collaboration across multiple functions. Ability to independently manage complex projects and drive continuous improvement initiatives. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ, the skin, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Our site in Uppsala is Galderma's Global Center of Excellence for Aesthetics, home to over 800 professionals working across R&D, manufacturing, clinical development, and commercial functions. Here, cutting-edge science meets world-class manufacturing, creating an environment where innovation moves rapidly from concept to patient impact. As a Senior Manufacturing Scientist – Aseptic Processing, you'll influence critical manufacturing processes, contribute to regulatory excellence, and play a direct role in delivering high-quality products to patients around the world, joining a collaborative and highly skilled team where your expertise is valued and your ideas are heard.

SallyQ AB

The role We call ourselves a 60-year-old startup. Decades of scientific heritage, paired with the speed, ambition and hands-on energy of a company being built from the ground up. Right now, we're scaling manufacturing fast, and that means the way we assure sterility needs to scale with it. We're looking for a Sterility Assurance Lead who wants to own that agenda from day one, not just maintain a system, but shape how sterility assurance grows alongside the site. You will own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Key Responsibilities Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards. Oversee environmental monitoring, cleanroom qualification, and aseptic practices. Review sterilization validations and lead media fill programs. Drive contamination risk assessments, investigations, and CAPAs. Act as SME during audits and inspections. Provide training and mentorship in sterility assurance best practices. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You're energized rather than unsettled by a fast-scaling environment, you bring a proactive, solution-oriented approach that lets you spot risks early, drive improvements, and push operational excellence forward even as priorities shift. You thrive in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You're confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance, and you see this growth phase as a chance to grow your own scope right along with it. Requirements Bachelor's or Master's degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline. 8–12 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry. Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits. Hands-on experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations. Skills Deep technical expertise in aseptic processing, sterilization technologies (moist heat, dry heat, filtration), and microbial contamination control. Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems. Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA, EMA, PIC/S). Experience performing risk assessments using tools such as FMEA, HACCP, or similar methodologies. Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives. Excellent documentation skills and a structured approach to problem-solving and investigations. Strong communication and collaboration skills with the ability to influence cross-functional teams. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

Carla AB

About Carla At Carla, we believe that more people should be able to drive electric vehicles. Therefore, we have set out to build the safest, most convenient and transparent way to sell, buy, or lease an electric car. Carla was founded in 2020 in Stockholm, with strong VC backing. We are now in an exciting growth phase and are looking for like minded people. That means being driven, humble, and excited about creating outstanding and effective experiences and smart solutions. Recruitment need We’re hiring a Tech Lead to drive both technical discovery and delivery of projects within an agile team context, and make sure we make long-term enhancements to our technology stack and team performance. We’re looking for a person who likes to both be hands-on in code as well as coach other engineers and engage with stakeholders to define key projects for the company’s success. You will manage four other engineers to lead technical discovery and delivery in one of two cross-functional product teams, as well as take a leading role in the evolution of our platform as a whole. Responsibilities include: Technical Leadership and Strategy Lead and manage a small team of developers (backend and frontend) within our business critical Commercial area that handles sourcing, valuation, sales, logistics and support, ensuring projects align with company objectives and deliver substantial results. Develop and execute clear, effective technical strategies to enhance team efficiency and project output. Hands-On Technical Involvement Participate hands-on in coding, debugging, and integrating systems to ensure quality outcomes. Work closely with your product manager, designer, engineers, and other departments to deliver solutions that meet both technical and business needs. Use modern development tools, including AI-assisted workflows, to raise your own and the team's speed, quality and impact. Resource Management and System Optimization Oversee resource allocation to maximize team productivity and meet deadlines. Regularly evaluate and improve system performance and architecture to ensure scalability and reliability. System Development and Quality Assurance Guide the development and deployment of robust systems across the full tech team, using GoLang and TypeScript. Implement quality assurance processes to maintain high standards for system stability, performance, and security. Integration and Technical Debt Management Manage integrations with external systems and APIs to improve platform functionality. Proactively identify and address technical debt to enhance code maintainability and system scalability. Data Engineering Support initiatives to utilize company data through tools like BigQuery, Looker Studio, and AI. Qualifications Strong background in software development and leadership, with a record of implementing practical, effective technical solution. Proficient in Go and TypeScript, and deep understanding of software design principles. Experienced, hands-on user of AI-assisted development tools, with strong judgment about when and how to apply them for efficiency without sacrificing quality. Excellent communication skills and the ability to lead and collaborate effectively with diverse teams. Experienced in cloud-based architectures and familiar with various development methodologies and project management practices. Fluent in Swedish and located in Stockholm If you are looking to lead a capable team and directly impact both commercial business efficiency, product quality and team effectiveness, Carla might be the right place for you.

SallyQ AB

Immedica Pharma has experienced remarkable growth in recent years and is now strengthening their Manufacturing/CMC organization with an experienced analytical expert. The Manufacturing/CMC team is responsible for overseeing all aspects of the production of Immedicas’s products, all of which are manufactured externally. This includes defining CMC strategy, ensuring regulatory compliance, and coordinating activities with CLOs and CMOs. As Senior Scientist Analytical Technology, you will play a key role in securing the quality, compliance, and lifecycle performance of analytical methods across Immedicas’s product portfolio. You will take the lead on analytical method transfers, validation activities, and continuous improvement initiatives, ensuring that our methods remain robust, efficient, and fit for purpose. This is a new role created to gather all ASAT activities; hence it gives an exceptional opportunity for someone who wants to take lead and grow with the role. You will collaborate cross‑functionally and act as a central analytical resource supporting product quality, life cycle management projects such as manufacturing tech transfers, regulatory submissions, and ongoing development needs. Since all laboratory work is conducted externally at CMOs and partner laboratories, success in this role requires strong collaboration skills, excellent communication, and the ability to build productive relationships with external partners. Main responsibilities: Act as analytical subject matter expert (SME) for Immedica’s products Own and oversee analytical method performance, including trending of analytical release and stability data Identify and drive improvements in analytical methods and control strategies Coordinate stability studies, ensuring product stability and shelf life Manage reference standards Act as analytical SME in supporting investigations, changes, CAPAs and life cycle management activities Act as analytical SME in regulatory submissions, including ownership of specifications Lead analytical method transfers, method development activities and comparability studies Collaborate closely with internal product teams and external manufacturing & laboratory partners (CMO/CLO) to ensure quality and timelines Why join? Immedica Pharma offers an innovative, dynamic workplace with short decision paths and a high degree of ownership. Being a part of the Manufacturing/CMC team means you will work with engaged colleagues in a specialist role with high visibility and influence. You will have opportunities for professional development and continuous learning in a highly competent CMC environment. Your profile You are a self‑driven analytical expert with strong pharma experience and broad scientific knowledge. You take clear ownership of your responsibilities and communicate effectively with both internal and external stakeholders. You act confidently as an SME, and are structured, quality‑focused, and improvement‑oriented. You thrive in fast-paced, hands-on environment and combine strong analytical expertise with a collaborative, business-oriented mindset. Qualifications: MSc or PhD in analytical chemistry, biotechnology, or a related field 5-10 years of experience in pharmaceutical development or manufacturing of biologics or small molecules, including GMP Experience in analytical validation, tech transfer activities and stability study setup Experience in performing a broad range of analytical methods in the laboratory, e.g. HPLC, spectroscopy, ELISA, bioassay Good understanding of statistical methods for establishing specifications and evaluating analytical outcomes Ability to interpret and implement regulatory requirements (ICH/FDA/EMA etc.) in method transfer and comparability Experience of working with external labs/CMOs Fluency in Swedish and English, both written and spoken It is a strong advantage if you also bring: Previous leadership experience, such as project management or team management Previous experience of working with QC operations Appealing? Send in an application as soon as possible. In this recruitment, Immedica are collaborating with SallyQ. For questions, contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se. About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases within metabolic, neurology, hematology & oncology, endocrinology and specialty care. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, external manufacturing, regulatory and medical affairs as well as market access. Serving patients in more than 50 countries, Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica was founded in 2018 by investment company Impilo and buy-in management and currently employs more than 180 people across Europe, the Middle East and the US. Of these, approximately 80 are based in the headquarters in Life City, Hagastaden, Stockholm. At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues. Open & Honest: We foster transparency, integrity, and trust through open communication. Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape. Empowered: We encourage collaboration and ownership, creating a supportive workplace where all team members’ contributions drive innovation and growth.

Ants Akademiskt Nätverk av Tekniska Studenter AB

Do you want to be part of a team that’s making a positive impact on the world? Do you want to contribute to solutions that help ensure safe drug delivery for patients around the globe? Then you might be our next Lead Engineer IoT. At Temperature Sensitive Solutions Systems (TSS), we help the world’s largest pharma companies ensure that every temperature‑sensitive drug, from bulk shipment to the last mile of a clinical trial, is safe for patients. Our solutions run in mission‑critical, regulated environments where stability, reliability, and traceability are essential. About the role As our new Lead Engineer IoT, you will take a technical lead role within our IoT domain. This domain spans the full value chain, from firmware running on physical devices and gateways in the field, to secure data ingestion and availability in our cloud-based SaaS applications and mobile solution. You will operate in complex systems environment where devices, gateways, cloud services, internal lifecycle tools, and user-facing applications must work seamlessly together. Close collaboration across embedded, backend, platform, DevOps, and application teams is a natural part of your everyday work. In addition to hands-on backend development with Java, you will: Drive technical direction within the IoT team Ensure stable and traceable data flows across the full IoT lifecycle Design and evolve Kubernetes-based services supporting device and data operations Take responsibility for monitoring, version control, and lifecycle management of our global gateway fleet Lead technical investigations, root cause analyses, and validation work in a regulated environment Strengthen the team through mentorship, technical guidance, and shared engineering practices About you You are an experienced software engineer who combines technical depth with the ability to bring others along. You are comfortable navigating complex systems and enjoy connecting the dots between devices, infrastructure, and applications. You work in a structured and pragmatic way, and you are used to environments where documentation, traceability, and quality assurance are part of everyday engineering. We believe you have: A master’s degree in computer science, engineering, or a related field Extensive experience in backend development with Java and preferably React Native Strong experience with Kubernetes and cloud-based environments Experience within IoT, connected devices, distributed systems, or large device fleets Fluency in English, both written and spoken If you have experience with Python, Azure, Infrastructure as Code or GitHub Actions we see that as a plus. Interested? Apply today! We will review your application as soon as possible. If you have questions or want to know more, feel free to reach out to Gabriella Hagström, Talent Acquisition Consultant, at gabriella.hagstrom@ants.se. Please note that background checks are conducted as part of our recruitment process.