Experience

Bjerking

• Civil Engineering
• 300 - 400 Employee

• Specialist - sterilisering/ Specialist - sterilization

  • Jan 2022 - Present

  Uppsala, Uppsala län, Sverige Expertis inom sterilsering. Främst ångsterilisering men även strålsterilisering, torrvärme och andra metoder. Arbetar även med produktvalidering, kvalificering och relaterade valideringsuppgifter. Erfarenhet från ISO9001, Medicinteknik och läkemedelstillverkning som processutvecklare, QA och Validering, erfarenhet av FDA-inspektioner/myndighetsinspektionet och auditering. Håller utbildning, medverkar vid framtagande av processer/design, genomför valideringar. 2022: Cytiva:… Show more Expertis inom sterilsering. Främst ångsterilisering men även strålsterilisering, torrvärme och andra metoder. Arbetar även med produktvalidering, kvalificering och relaterade valideringsuppgifter. Erfarenhet från ISO9001, Medicinteknik och läkemedelstillverkning som processutvecklare, QA och Validering, erfarenhet av FDA-inspektioner/myndighetsinspektionet och auditering. Håller utbildning, medverkar vid framtagande av processer/design, genomför valideringar. 2022: Cytiva: Validation lead, medias for chromatography used in Covid Vaccine manufacturing. Scale up projects for resin, media & protein production, automation/validations. Support client in sterilization & cleaning general activities.

• Senior Consultant QA/Validation - Sterilization

  • Jan 2016 - Jan 2022

  Uppsala, Sweden Currently on: Cytiva 2016: GEHC- utensils & solutions loads, RQ procedures. 2016: GEHC-Sterilization Professional-ISO11137 Product 2016: Galderma-Evaluation and Approach, terminal sterilized products. 2016-2017: Galderma: Development of Sterilization process, Utensils. Evaluation, reporting & aid in Dry Heat Sterilization/Depyrogenation. Turnover approach (Bioburden/Bioindicator cycles to Overkill F0-concept/fullcycle). 2016-2017: Recipharm: New autoclave, terminal… Show more Currently on: Cytiva 2016: GEHC- utensils & solutions loads, RQ procedures. 2016: GEHC-Sterilization Professional-ISO11137 Product 2016: Galderma-Evaluation and Approach, terminal sterilized products. 2016-2017: Galderma: Development of Sterilization process, Utensils. Evaluation, reporting & aid in Dry Heat Sterilization/Depyrogenation. Turnover approach (Bioburden/Bioindicator cycles to Overkill F0-concept/fullcycle). 2016-2017: Recipharm: New autoclave, terminal Sterilization. Evaluation, Criticality, specifications, FAT, Validation. 2017 GEHC: rebuild CIP equipments, PQ Filling, RQ of Sterilization, aid Autoclave URS. 2017 Recipharm: Specification-FAT, New autoclave, utensils/terminal Sterilization rigid containers. Pre studies. 2017 Galderma: Education: Moist heat sterilization, Spores/SAL/D-value/Z-value/F0/FBIO/Survival & Kill time-calculations. Theory vs reality . CC (load parts). Hold time post Sterilization. Specification & purchase of Bioindicators for different Sterilization methods. Recipharm: Autoclave - URS, Replacement, utensils & open containers 2018 Galderma: Development of decontamination processes (bio waste), Share, evaluate & co-author development reports for Depyrogenation of tunnel & Dry heat Sterilization of tunnel cooling zone. Recipharm - Autoclave installation project, Expertice, Test strategies, system impact assessment, specifications, Design, FAT. Validation leader GEHC- Develop & Qualification of Heat treatment for 4 Products, high density media & other media Galderma - Develop sterilization processes, products/utensils. 2019-2020 Galderma: Evaluating products vs D-values,, Failure analysis-Root cause in autoclave processes, GEHC: Fermentation & purification, PQ (multiple processes). Aid URS autoclave, Reviews. CV rationales. Chromatography media PQ. SAT-IQ Equipments. Validation Summary Plan Smaller Projects- Education: Audit acc to ISO 17665, ISO11137 VDmax, CV. 2021: Fermentation, purification, Covid related media Validation/PQ

• Senior consultant QA/Validation-Sterilization

  • Jan 2016 - Jan 2022

  Uppsala, Sweden Consultant in Sterilization and Validation. Moist heat Sterilization. Lean risk based approach validation



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sterilization Professional

  • Jan 2014 - Jan 2016

  Uppsala, Sweden Lead - Quality Assurance with Sterilization processes, Validations and qualifications in focus. Quality assurance of validations and qualifications.

• Product manager

  • Aug 2008 - Dec 2013

  Uppsala, Sweden Responsible for Validation documentation. Education of internal resourses for validation. Specialized in validation for customized bioprocess systems, HPLC and filtration systems



Advanced Medical Optics

• Medical Equipment Manufacturing
• 300 - 400 Employee

• Sterility Assurance Engineer, Process Development

  • Jun 2004 - Jul 2008

  Uppsala, Sweden Responsible for the development, implementation, facilitating and validation of Sterilization and Depyrogenization equipments in a Pharmaceutical and Medical Device production.



Pharmacia, Kabi Pharmacia, Pharmacia & Upjohn, Pfizer, Advanced Medical Optics

• Laboratory engineer/Process developer, Senior process developer, Sterility assurance engineer

  • Jan 1995 - Jul 2008

  Uppsala/Stockholm (Pharmacia (now: Pfizer, Octapharma, SOBI, AMO, Fresenius) 1995-1996 Development: Pharmacokinetics in a global Clinical phase III project (recombinant factor VIII). Also involved in an anastesia project. Performed examination work earlier: Studied trauma and growth factors in muscular tissues. 1996-2000 Sterilization: Laboratory Engineer Microbial lethality kinetics of spores (Geobacillus stearothermophilus, Clostridium sporogenes and others), Qualification of sterilization processes 2000-2008 Sterilization: Process development and Senior Process… Show more 1995-1996 Development: Pharmacokinetics in a global Clinical phase III project (recombinant factor VIII). Also involved in an anastesia project. Performed examination work earlier: Studied trauma and growth factors in muscular tissues. 1996-2000 Sterilization: Laboratory Engineer Microbial lethality kinetics of spores (Geobacillus stearothermophilus, Clostridium sporogenes and others), Qualification of sterilization processes 2000-2008 Sterilization: Process development and Senior Process Developer, Sterilization (Autoclaves), Dry heat (Autoclaves) , Steam cycles (Sterilization In Place, Bioburden cycles, Overkill), Got in touch with Aseptic work, Cleaning Validation, Radiation Sterilization and Depyrogenization cycles (Tunnels). Development as well as Thermal and microbial measurement and hands on mechanic error searching Show less