SME Facility Management System

CCRM Nordic AB (svb)

About CCRM Nordic CCRM Nordic breaks down the bottlenecks that slow life-changing therapies from lab to patient. Based at GoCo Health and Innovation City in Mölndal, we provide ATMP teams across Sweden, the Nordics and Europe with the infrastructure, know-how and partner network they need, whether that means a single consultation or a long-term manufacturing collaboration. We have invested in a brand-new GMP manufacturing facility with five processing rooms on floor 16 of GoCo House. We are now building the founding team that will shape how this facility runs, and are looking for a Manufacturing Team Lead ready to be part of something genuinely exciting. The opportunity This is a founding role. As one of the first hires into the manufacturing team, you will help build the structure, not just step into it. From authoring SOPs and batch records to training operators and leading quality investigations, this role sits at the operational heart of CCRM Nordic's manufacturing capability. You will lead a team of up to six GMP operators across multiple processing rooms, manage day-to-day scheduling and training, and act as the department's SME for quality systems. You will work alongside PD and MSAT colleagues on new product introductions and technology transfers, and collaborate with our Validation team on equipment qualification and process establishment. Key responsibilities Manufacturing Operations Lead day-to-day GMP manufacturing operations across multiple processing rooms, ensuring clinical materials are delivered on time and to the highest quality standard. Perform and oversee hands-on processing including cell culture, bioreactor operation, Tangential Flow Filtration (TFF) and chromatography. Schedule and manage housekeeping, environmental monitoring and cleaning activities, internally and with external contractors. Maintain full inventory control, ensuring consumables and raw materials are stocked and within expiry. People & Team Leadership Line manage a team of up to six pharmaceutical operators, including performance management, workload planning and day-to-day support. Design and deliver training plans to ensure every team member is qualified for all processing and ancillary activities. Act as a role model for a collaborative, high-performance culture: mentoring and developing the people around you. Quality & Compliance Serve as the manufacturing SME for all GMP quality matters, leading incident investigations, root cause analyses, change controls and CAPAs. Ensure all operations are executed in strict accordance with approved SOPs, Batch Manufacturing Records and current GMP guidelines. Author and review SOPs, batch records, logbooks, COSHH assessments and User Requirement Specifications for new equipment. Support regulatory inspections and ensure the facility is always inspection-ready. Collaborate with the Validation Department on equipment calibration, qualification and shutdown planning. New Product Introduction & Tech Transfer Partner with PD and MSAT teams to introduce new products and processes into the GMP suite. Support technology transfers into and out of the facility, including handovers to clients or CMOs. What we are looking for Essential Minimum 5 years' GMP manufacturing experience, with a strong focus on bioproduction or ATMPs. Proven track record as a line manager of a GMP manufacturing team. Hands-on experience with ATMPs, ideally including Viral Vectors or similar advanced modalities. Degree in bioprocessing, microbiology or a related life science discipline, or equivalent experience. Deep working knowledge of GMP QMS systems: quality incidents, change controls and CAPA management. Experience authoring SOPs, batch records and validation documentation. Strong communication skills and ability to collaborate across functions. Highly Desirable Experience in Tech Transfer and process validation. Hands-on operation of TFF systems, including Repligen platforms. Experience supporting or participating in regulatory inspections. The person We are looking for someone who is: A strong team player who invests in the people around them and understands that great manufacturing is a collective achievement. Adaptable and calm under pressure, able to pivot when processes change, timelines shift or unexpected challenges arise. Energised, not overwhelmed, by the complexity of a new facility and evolving product portfolio. Service-oriented and delivery-focused, with high personal standards for accuracy and thoroughness. An excellent organiser who can hold multiple priorities without letting quality slip. Why join CCRM Nordic? CCRM Nordic is an innovation-led organisation at the frontier of ATMP development. Joining now means helping to shape the team, culture and operational standards of a facility that will directly contribute to getting advanced therapies to patients faster. A rare opportunity to join a founding manufacturing team and leave your mark on how things are built. Work alongside world-class scientists and process development experts on cutting-edge ATMP programmes. A collaborative, supportive environment where your expertise is genuinely valued. Clear pathways for growth as the team expands from Phase 1 through to full multi-project manufacturing capacity. Competitive salary in line with the Swedish pharmaceutical market. Ready to build something important? We'd love to hear from you.

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.

Randstad AB

Arbetsbeskrivning Är du en driven person som trivs i händelsernas centrum och vill ta nästa steg i karriären? Vi på Randstad Life Sciences söker nu en självständig specialist inom cleaning validation till en av våra kunder i Strängnäs. Har du dessutom erfarenhet av omgivningshygien/mikrobiologiska frågeställningar i läkemedelsproduktion är det ett plus. Som konsult hos oss blir du en del av ett starkt team där din kompetensutveckling står i fokus. Vi kombinerar tryggheten i ett kollektivavtal med spänningen i att få arbeta på olika innovativa företag. I rollen som konsult hos Randstad Life Sciences får du chansen att kliva in i nyckelroller hos några av branschens mest välrenommerade aktörer. Rollen är dynamisk och kräver en driven person som trivs med problemlösning och tvärfunktionellt samarbete. Du agerar ofta som bryggan mellan produktion och kvalitet, och förväntas ta ett stort ägandeskap för ditt ansvarsområde. Som konsult hos oss får du dessutom en engagerad konsultchef som stöttar dig i din yrkesresa, samt ett nätverk av kollegor där vi varvar kunskapsutbyte med sociala aktiviteter och AWs. Om du kör eget så är du också varmt välkommen att söka, då går du via oss som underleverantör. Varmt välkommen med din ansökan! Ansvarsområden Som SME inom Cleaning validation kommer dina arbetsuppgifter bland annat att innefatta: Genomföra och koordinera rengöringsprocesser samt rengörings valideringar (CV) för nya och befintliga processer och utrustningar Utfärda protokoll/program och rapporter för rengöringsvalidering. Hantera avvikelser, ändringsärenden och riskanalyser inom kompetensområdet Driva kontinuerligt förbättringsarbete och optimering av rengöringsprocesser Främja tvärfunktionellt samarbete (Kvalitet, Engineering, MS&T, Operations). Driva lösningar av tekniska utmaningar och ge stöd under inspektioner Främja en kultur av regel efterlevnad, ansvarstagande och kontinuerlig förbättring i enlighet med GMP och företagets standarder. Delta i omgivningshygien arbete Kvalifikationer Universitetsexamen inom tex bioteknik, livsmedelsteknik, naturvetenskap, kemiteknik eller motsvarande. Några års erfarenhet av arbete med rengöringsprocesser och rengöringsvalidering inom läkemedelsindustrin GMP. Erfarenhet av omgivningshygien/mikrobiologiska frågeställningar är meriterande. Goda kunskaper i svenska och engelska (i tal och skrift). God datorvana (MS Office: Word, Excel, PowerPoint). Om företaget Randstad På Randstad vet vi att alla människor har en plats på arbetsmarknaden. Med verksamhet över hela landet och inom alla kompetensområden hjälper vi människor att hitta ett jobb som känns bra, och där de får möjlighet att växa, utvecklas och uppnå sin fulla potential. Med närmare 600 000 anställda i 38 länder är Randstad världsledande inom HR-tjänster, med målsättningen att bli världens främsta och mest uppskattade partner på arbetsmarknaden. Genom att kombinera vår passion för människor med kraften i dagens teknologi hjälper vi människor och företag att uppnå deras fulla potential. Vi kallar det Human Forward.