These jobs were popular with other job seekers Drake Personnel (SA) Pty Ltd - Cape Town Drake Personnel (SA) Pty Ltd - Cape Town Internal employee, EE/AA, Non EE/AA, Disabled Easy apply IntroductionWatchmaker Genomics is a global life science company with an R&D and Production facility in Cape Town, South Africa and head offices in Boulder, Colorado. Our team is passionate about innovation and values collaboration, creativity, and scientific rigor. We believe that the intersection of biology, engineering, and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health. Watchmaker specializes in the design, development, and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalized medicine. Watchmaker Genomics is inviting applications for a Process Development Scientist/Engineer- Fill and Finish. This is a full-time position based in Cape Town, South Africa. This position reports to the Process Development Lead and will be responsible for the design, improvement, and technical transfer of manufacturing filling & assembly processes from R&D into Production. This is a highly collaborative position that involves working closely with members of other departments such as R&D, Manufacturing, Marketing, Quality Control, and Quality Assurance.The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success. The position provides an opportunity to grow and develop as a scientist, and gain valuable experience at the intersection of R&D, Production, and Product Development.Duties & ResponsibilitiesResponsibilitiesDrive the design & implementation of the following processes:Filling and labeling of vials Product assembly, packaging and shippingGenerating product documentation such as certificates of analysis, safety data sheets and user guides Label template design, and system integration with labeling equipment and softwareEffective in-process checks that meet quality standardsDrive manufacturing process design-related activities throughout the Product Life Cycle including product development and continuous improvementCollaborate with R&D and Production to develop and transfer processes, including defining critical process parameters and identifying and mitigating risksIdentify and drive implementation of Production requirements such as materials, equipment, software, instructions as well as advise on facilities design Independently design, optimize and implement new and existing processes while maintaining compliance to proceduresAuthor, revise and publish relevant documentation such as work instructions, batch record templates, risk analyses and project reportsTrain relevant users in new and revised processesLead and/or contribute to projects with cross-functional teamsContribute to the planning and execution of validation activities such as process validation, computer systems validation and equipment qualificationDesign, execute and record experiments with scientific rigorAnalyze and interpret experimental results including graphing and statistical analysisRecord, communicate and present findings with accuracy and clarityContribute to laboratory maintenance including ordering of raw materials, maintaining equipment and cleaning/organizing the lab Other duties as assignedDesired Experience & QualificationSkills and RequirementsThe following skills and experience would be advantageous for the position:Experience in process development and implementation for reagent manufacturing specifically for vialing and assembly of finished goodsDemonstrated ability to design and monitor processes using statistical methods such as Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA) and Gage Repeatability & Reproducibility (Gage R&R)Experience with production-related systems such as: Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS)Experience planning, executing and reporting on validation activities including process validation, computer systems validation and/or equipment qualificationBroad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR and recombinant protein production are all highly desirableFamiliarity with ISO9001 and/or ISO13485 standards or operating within a structured quality management system (QMS)Demonstrated scientific excellence in technical work, written communication and presenting technical information to groups with various scientific backgroundsThe ability to multitask, perform consistently under pressure and work without supervisionStrong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teamsExcellent organizational skills and outstanding attention to detailGood communication and personal task management skills and a high level of self-motivationAbility to determine project timelines and meet deadlines Excellent written and verbal communication skillsEducationMinimum qualifications equivalent to MSc in molecular biology, biochemistry or BEng Hons in engineering or a related discipline is requiredA minimum of 3 years in biotech or related industry, including positions with broad functional scope across research and development, technical transfers, manufacturing, quality control, and quality assuranceInterested? To apply for the position, please submit the following on Indeed.com,Letter of motivation Resume or Curriculum vitae, highlighting relevant qualifications and experience; including the following: current physical address, email address, and mobile phone number.Applications without a Letter of Motivation will not be considered. Local candidates preferred.If selected to participate in the interview process, the names and contact information of two references who are able to assess your suitability for the position in terms of the specified requirements will be requested.WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERWatchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.This position may be subject to pre-employment checks, including driving history check, drug screening, and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable local laws. Medical Technology Pharmaceutical Sector Scientific, Research & Development These jobs were popular with other job seekers Drake Personnel (SA) Pty Ltd - Cape Town
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