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3 jobs found in Oensingen, Solothurn

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    • luterbach, solothurn
    • contract
    Do you want to work in a biotech company? Do you have experience as a Technical Writer in a GMP environment ? You should then read the following lines! Our client, based in Solothurn, is looking for a  Technical Writer for a 7 months contract. Home based but supporting the Solothurn Drug Substance manufacturing facility, this Manufacturing Sciences position provides technical writing expertise and support to complete technical reports in support of regulatory filings and campaign completion. Solid technical understanding of bioprocessing technologies (mammalian cell culture, bioreactors, perfusion and fed-batch strategies, PAT, chromatography, UF/DF and filtration) is required. Position reports to program TT leader (the overall TT project manager) and will work with guidance from that lead to collect data from various data system (OSI Pi, SIMCA and LIMs) to populate report templates. The position requires knowledge in working within electronic documentation management systems and knowledge of GMP documentation practices and procedures. The position will work cross-functionally with other members of the project team in Manufacturing Science and other functions such as Quality, Engineering and Operations. Your Responsibilities: 1. Drive technology report completion, cross-functional (Operations, Development, Process and Automation Engineering, QA and QC) process transfer team to ensure success in project documentation and closure.2. Collect data from various process data systems to support report data population and be able to interpret data for initial data analysis and conclusions.3. Provide Technical Writer and report status updates to the program TT lead and provide routine updates to other functions regarding technical report status and completion of key milestone. Your profile: BS with minimum 5 years of experience in bioprocess manufacturing process, or MS with minimum 3 years experience in upstream processBachelor’s or Master degree in Chemical or Bioprocess Engineering, Biochemistry, Chemistry, Biology or closely related discipline Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a biotech company? Do you have experience as a Technical Writer in a GMP environment ? You should then read the following lines! Our client, based in Solothurn, is looking for a  Technical Writer for a 7 months contract. Home based but supporting the Solothurn Drug Substance manufacturing facility, this Manufacturing Sciences position provides technical writing expertise and support to complete technical reports in support of regulatory filings and campaign completion. Solid technical understanding of bioprocessing technologies (mammalian cell culture, bioreactors, perfusion and fed-batch strategies, PAT, chromatography, UF/DF and filtration) is required. Position reports to program TT leader (the overall TT project manager) and will work with guidance from that lead to collect data from various data system (OSI Pi, SIMCA and LIMs) to populate report templates. The position requires knowledge in working within electronic documentation management systems and knowledge of GMP documentation practices and procedures. The position will work cross-functionally with other members of the project team in Manufacturing Science and other functions such as Quality, Engineering and Operations. Your Responsibilities: 1. Drive technology report completion, cross-functional (Operations, Development, Process and Automation Engineering, QA and QC) process transfer team to ensure success in project documentation and closure.2. Collect data from various process data systems to support report data population and be able to interpret data for initial data analysis and conclusions.3. Provide Technical Writer and report status updates to the program TT lead and provide routine updates to other functions regarding technical report status and completion of key milestone. Your profile: BS with minimum 5 years of experience in bioprocess manufacturing process, or MS with minimum 3 years experience in upstream processBachelor’s or Master degree in Chemical or Bioprocess Engineering, Biochemistry, Chemistry, Biology or closely related discipline Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • luterbach, solothurn
    • contract
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    • solothurn, solothurn
    • contract
    Do you want to work in a big medical devices company? Do you have more than 2 years experience in Regulatory Affairs? You should then read the following lines! Our client, based in Solothurn, is looking for a Life Cycle Management RA support for a contract until the end of 2022. OVERALL RESPONSIBILITIESSupport the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to• European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,• US FDA 510(k) submissions or Notes to file, as applicable,• As well as country registrations on a world-wide basis, as appropriate.in the context of Life Cycle Management projects (e.g. change of manufacturing process and/or equipment, change of manufacturing site, etc.). POSITION DUTIES & RESPONSIBILITIES• Ensuring that the company's products comply with the regulations set up by government agencies• Advising engineering and other support functions, as well as manufacturing on regulatory requirements• Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities• Creating, reviewing and maintaining regulatory related technical documentation• Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals• Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations• Providing progress of work-plans and the status of key project deliverables EXTENDED DUTIES• Follow the applicable quality standards and regulatory requirements• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times• Resolving complex issues as they arise PROFESSIONAL EXPERIENCE REQUIREMENTS:• Strong knowledge ofo ISO 13485 and ISO 9001, QSRo Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentationo MEDDEV guidance documents applicable to Medical Devices products and processes• Reasonable knowledge ofo FDA requirementso registration requirements in further global markets would be an asset• Strong understanding of Risk Management process, label and labeling, change management is desired• International experience preferred• Proven exceptional written and oral communication skills EDUCATIONAL REQUIREMENTS• Bachelor's (minimum 3 years’ experience) or Master’s (minimum 2 year of experience) Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.OTHER REQUIREMENTS• Familiarity with Technical Documentation structure according to STED required• Teamwork oriented, within a multi-functional and multi-national team• Strong interpersonal and diplomatic skills• Customer / service orientation• High analytical, planning and organizational skills; able to set priorities• Strong knowledge and skills in MS Office Do not waste any minutes, apply now!  We are looking forward to receiving your application.
    Do you want to work in a big medical devices company? Do you have more than 2 years experience in Regulatory Affairs? You should then read the following lines! Our client, based in Solothurn, is looking for a Life Cycle Management RA support for a contract until the end of 2022. OVERALL RESPONSIBILITIESSupport the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to• European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,• US FDA 510(k) submissions or Notes to file, as applicable,• As well as country registrations on a world-wide basis, as appropriate.in the context of Life Cycle Management projects (e.g. change of manufacturing process and/or equipment, change of manufacturing site, etc.). POSITION DUTIES & RESPONSIBILITIES• Ensuring that the company's products comply with the regulations set up by government agencies• Advising engineering and other support functions, as well as manufacturing on regulatory requirements• Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities• Creating, reviewing and maintaining regulatory related technical documentation• Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals• Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations• Providing progress of work-plans and the status of key project deliverables EXTENDED DUTIES• Follow the applicable quality standards and regulatory requirements• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times• Resolving complex issues as they arise PROFESSIONAL EXPERIENCE REQUIREMENTS:• Strong knowledge ofo ISO 13485 and ISO 9001, QSRo Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentationo MEDDEV guidance documents applicable to Medical Devices products and processes• Reasonable knowledge ofo FDA requirementso registration requirements in further global markets would be an asset• Strong understanding of Risk Management process, label and labeling, change management is desired• International experience preferred• Proven exceptional written and oral communication skills EDUCATIONAL REQUIREMENTS• Bachelor's (minimum 3 years’ experience) or Master’s (minimum 2 year of experience) Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.OTHER REQUIREMENTS• Familiarity with Technical Documentation structure according to STED required• Teamwork oriented, within a multi-functional and multi-national team• Strong interpersonal and diplomatic skills• Customer / service orientation• High analytical, planning and organizational skills; able to set priorities• Strong knowledge and skills in MS Office Do not waste any minutes, apply now!  We are looking forward to receiving your application.

Explore over 3 jobs in Oensingen

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