Job DescriptionOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.This role will support manufacturing operations on a 24/7 shift pattern and mayinclude extended hours.Specific Job Duties: Act as aseptic guardian of Cleanrooms Grade A/B/C/DGuiding and training junior members of staffAct as delegate for shift lead/managerOwnership of monthly & annual trend reports, readouts & actions, includingpresentation the EM trends during auditsParticipate in audits, initiatives, and projects that may be departmental ororganizational in scope.Approve lab resultsInitiate and/or implement changes in controlled documents.Evaluate lab practices for compliance and operational excellenceimprovement on a continuous basis.General job duties:Environmental Monitoring of Grade 8/9 CleanroomsEnvironmental Monitoring of Grade 5/7 Cleanrooms & IsolatorsReading of Environmental Monitoring PlatesBioburden testing of water & disinfectantsWater samplingTesting of In Process samples such as Protein Concentration, Density & pHDRequirementsBachelors degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing ofpharmaceutical products Experience working in an aseptic cleanroom performing EnvironmentalMonitoring is absolutely necessaryPreferred Qualifications Proficient in the use of LIMS & LMESExperience in a senior role, providing guidance to team membersKnowledge of related regulatory/industry considerations, compliance issuesand/or scientific discoveryExperience with regulatory compliance in cGMP manufacturing and testing ofpharmaceutical productsCompetencies :Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Change Control, Trackwise, SAP and CDOCS anadvantage Flexibility – the EM role often encounters changing priorities on a daily basisProblem solving skillExperience with Regulatory inspectors and interacting with inspectorsdesirableDemonstrated ability to work independently and deliver right first time resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows proceduresRefers to technical standards, principles, theories and precedents as neededMay set project timeframes and priorities based on project objectives andongoing assignments.Recognizes and escalates problemsAuditing documentation and operation processDemonstrated ability to interact with regulatory agenciesPackage3 - 5 years experience - ca €50 - 55K per annum + 35% shift uplift (ca €75K per annum)Benefits include performance related bonus, pension, VHI for family and 23- 26 days Annual Leave + Public HolidaysShift pattern will be 2 days, 2 nights (4 days off) rolling forward 1 day each week