We are currently supporting a leading pharmaceutical company in Bern, in their search for an experienced Commissioning & Qualification Engineer.Responsibilities:The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Qualification/Validation Master plans are up to date and established for all ongoing projectsWrite/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipmentExecution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipmentPlan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelinePrepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partnersCoordination and oversight of external suppliersQualifications:Bachelor/Master’s degree in technical or natural sciencesA minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent positionKnow-how of Qualification requirements according to cGMP regulationsExperience working with cross-department stakeholdersKnow-how of quality assurance principlesExperience working in project teams and multiple projects in parallelExperience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plusExcellent communication skillsAnalytical thinking and problem-solving abilityBusiness fluency in English, German language is a plusSelf time managementIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today. Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.
We are currently supporting a leading pharmaceutical company in Bern, in their search for an experienced Commissioning & Qualification Engineer.Responsibilities:The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Qualification/Validation Master plans are up to date and established for all ongoing projectsWrite/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipmentExecution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipmentPlan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelinePrepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partnersCoordination and oversight of external suppliersQualifications:Bachelor/Master’s degree in technical or natural sciencesA minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent positionKnow-how of Qualification requirements according to cGMP regulationsExperience working with cross-department stakeholdersKnow-how of quality assurance principlesExperience working in project teams and multiple projects in parallelExperience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plusExcellent communication skillsAnalytical thinking and problem-solving abilityBusiness fluency in English, German language is a plusSelf time managementIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today. Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.
We are currently supporting a leading pharmaceutical company in Bern, in their search for an experienced Commissioning & Qualification Engineer (thermomapping specialist).Responsibilities:You will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:- (re-) qualification of production/QC equipment including Thermomapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Qualification/Validation Master plans are up to date and established for all ongoing projectsWrite/review Qualification/Validation plans and final reportsExecution of IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activitiesPlan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelinePrepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)Coordinate and execute commissioning activities in collaboration with internal and external partnersCoordination and oversight of external suppliersQualifications:Bachelor/Master’s degree in technical or natural sciencesWorking experience within pharma/Medical Devices companiesKnow-how of Qualification requirements according to cGMP regulationsKnow-how of thermomapping studiesKnow-how of quality assurance principlesExcellent communication skillsAnalytical thinking and problem-solving abilityBusiness fluency in English, German language is a plusSelf time managementIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today. Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.
We are currently supporting a leading pharmaceutical company in Bern, in their search for an experienced Commissioning & Qualification Engineer (thermomapping specialist).Responsibilities:You will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:- (re-) qualification of production/QC equipment including Thermomapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Qualification/Validation Master plans are up to date and established for all ongoing projectsWrite/review Qualification/Validation plans and final reportsExecution of IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activitiesPlan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelinePrepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)Coordinate and execute commissioning activities in collaboration with internal and external partnersCoordination and oversight of external suppliersQualifications:Bachelor/Master’s degree in technical or natural sciencesWorking experience within pharma/Medical Devices companiesKnow-how of Qualification requirements according to cGMP regulationsKnow-how of thermomapping studiesKnow-how of quality assurance principlesExcellent communication skillsAnalytical thinking and problem-solving abilityBusiness fluency in English, German language is a plusSelf time managementIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today. Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.
Are you an experienced Project Lead Engineer (Refurbishment Project) and you are looking for a long-term contracting challenge until the end of 2022 in Bern? Tasks and responsibilities:Leads and coordinates technical investment projects in field of utilities, infrastructure, equipmentImplements of specifies project goals with adherence to time, cost and quality requirementsPrepares and submits investment requestsGuarantees that approved projects and changes to systems, facilities, infrastructure and utilities meet all required building authority, GMP requirements as well as environmental and safety standardsLeads cross-functional teams for different projects, initiativesManages relationships externally and internallyCoordinates with global engineering, EHS regarding technology standards and specificationsCreates and guarantees of perfect project documentation and reportingExpands and maintains existing supplier networkAnalyzes project technical requirements and institution of specific guidelines for the immediate engineering activityConducts investigations to troubleshoot problems and leads changes to correct themEnsures and documents that approved projects are executed and that any changes to systems and production systems make all required GMP requirements and EHS compliantMust haves:German and English fluencyTechnical degree (TS, HTL) with at least 10 years of relevant professional experienceProven track record in the field of project management in the pharmaceutical industry, from planning, execution to commissioning of equipment, utilitiesStrong technical skills in the construction of pharmaceutical sites and their infrastructureExperience not only on Equipment, but also on construction, refurbishments, facilities, utilities etc.Extensive knowledge and experience in the core business and technical areaExperienced in working with internal departments (development, operations, quality, technical services) to carry out projects, develop standards and define project requirements and prioritiesExperience working with different stakeholders, internally and externallyProfound GMP-knowledge (EU and US)Strong communicationSkills in time and self-managementAnalytical thinking and problem-solving skillsTeam playerExperience with various IT-tools and systems, especially MS OfficeIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today.
Are you an experienced Project Lead Engineer (Refurbishment Project) and you are looking for a long-term contracting challenge until the end of 2022 in Bern? Tasks and responsibilities:Leads and coordinates technical investment projects in field of utilities, infrastructure, equipmentImplements of specifies project goals with adherence to time, cost and quality requirementsPrepares and submits investment requestsGuarantees that approved projects and changes to systems, facilities, infrastructure and utilities meet all required building authority, GMP requirements as well as environmental and safety standardsLeads cross-functional teams for different projects, initiativesManages relationships externally and internallyCoordinates with global engineering, EHS regarding technology standards and specificationsCreates and guarantees of perfect project documentation and reportingExpands and maintains existing supplier networkAnalyzes project technical requirements and institution of specific guidelines for the immediate engineering activityConducts investigations to troubleshoot problems and leads changes to correct themEnsures and documents that approved projects are executed and that any changes to systems and production systems make all required GMP requirements and EHS compliantMust haves:German and English fluencyTechnical degree (TS, HTL) with at least 10 years of relevant professional experienceProven track record in the field of project management in the pharmaceutical industry, from planning, execution to commissioning of equipment, utilitiesStrong technical skills in the construction of pharmaceutical sites and their infrastructureExperience not only on Equipment, but also on construction, refurbishments, facilities, utilities etc.Extensive knowledge and experience in the core business and technical areaExperienced in working with internal departments (development, operations, quality, technical services) to carry out projects, develop standards and define project requirements and prioritiesExperience working with different stakeholders, internally and externallyProfound GMP-knowledge (EU and US)Strong communicationSkills in time and self-managementAnalytical thinking and problem-solving skillsTeam playerExperience with various IT-tools and systems, especially MS OfficeIf this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today.