About us Your Contribution Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure Lead/support validation and qualification for equipment, products, processes, etc.Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed Promote safety and EHS and adhere to all Company policies, procedures and guidelines Your Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach
About us Your Contribution Provide support to Production by visually inspecting sterilized glass vials throughout daily activities; identify and classify defectsPerform visual inspection and testing of incoming materials using statistical sampling techniques, precision measuring instrumentation and FT-IR to ensure conformancePerform laboratory tests including endotoxin, bioburden and sub visible particlePerform Environmental Monitoring in ISO level Clean Room including compressed air testingConduct inventory of laboratory supplies and communication needs for order placement(s)Collect WFI (Water For Injection) for testing using aseptic techniqueCommunicate non-conforming issues and interact effectively with proper contact(s)Demonstrate flexibility in providing coverage during instances of co-work vacation time and/or medical absence(s)Cross train in other areas and/or functions of the laboratory to support business needsComplete daily, weekly and monthly cleaning of applicable laboratory areasReview testing documents for completeness and accuracyMaintain all laboratory notebooks and equipment log booksWork on all assigned tasks, projects and daily tasksFollow all Company policies and proceduresParticipate in required trainings and meetings, when necessaryHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language
About us Your Contribution Ensure throughput and product qualityReview production KPI reports and electronic board for accuracy; control production order variances (hours/material/consumption)Review and manage re-inspection backlogs, quality issues and machine changes, along with handling and material issuesLead, instruct and motivate team employees on department deliverables and objectivesSupervise work performance, perform audits, provide control measures within the range of responsibility, and determine necessary improvement activitiesParticipate in the preparation and modification of job descriptions and the hiring processCreate planning documents and schedule/organize staffing to meet business needs based on the production schedule, vacations, call-offs, special needs, etc.Foster open communication with the Operations Manager, while reporting on all relevant data (production quantities, quality, accomplished order production, tool availability, maintenance tasks, etc.)Host daily shift meetings to provide daily instruction and staff allocationAssist in the development and implementation of training programs, in conjunction with the Department Training Coordinator, while continuously evaluating needs per positionPerform annual performance evaluations; document as requiredIssue disciplinary action for poor performance and/or misconduct, etc.Ensure clean workspaces on the Production floorMaintain the accuracy of employee time and attendance within the payroll systemLead and foster troubleshooting activities regarding potential issues on the Production line(s)Help promote and implement safety/EHS directives and maintain a clean and safe workspaceFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, requiredExperience in leading and directing the work of others in a fast paced manufacturing settingExperience in machine operation; glass manufacturing experience highly preferredUnderstanding of ISO and cGMP, preferredAbility to follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachRobust communication skills and openness to learn/develop Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredExperience in leading and directing the work of others in a fast paced manufacturing settingExperience in machine operation; glass manufacturing experience highly preferredUnderstanding of ISO and cGMP, preferredAbility to follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachRobust communication skills and openness to learn/develop
We know: motivated and committed employees are the precondition for the success of our company. Medical, Dental and Vision coverage; Free Parking; Holistic corporate health management; Multiple career opportunities; Social Insurance System; Talent development; Team Events Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
About us Your Contribution Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectivesAssist in developing department budget and investment plan(s) according to strategic goalsCultivate employee talent through training and coaching measures, while also conducting employee performance reviewsSupport the development and updating of Quality Assurance programs, policies, processes, procedures and controlsReview, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepanciesManage the review of batch records and avoid impacting shipment datesManage Department Training Coordinator activities and projectsManage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documentsLead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirementsMeasure and analyze Quality System trendsOversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)Maintain the Archive Room and document retention requirementsWrite and revise Standard Operating Procedures (SOPs) and provide training, as requiredManage the CAPA and Change-Control process to include, issuing, reviewing and approving stepsSupport all customer or registrar quality related audits and/or evaluationsUtilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business UnitManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findingsHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceAssure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines Your Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language
Promote and facility workplace safety and follow EHS guidelines Your Profile Scientific/Engineering and/or Business Administration degree, or equivalent, required 7 - 10 years in technical Sales and experience in selling/engineering of technical products in an international environment, strongly desired Experience in planning, managing and coordinating customer and market strategies, preferred Excellent oral and written communication skillsAbility to read, write and speak English Demonstrated ability to problem solveExperience managing both small and large account Strong technical background, including technical terminology and conceptsIntercultural awareness Ability to work independentlyAbility to travel frequently, as required Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Scientific/Engineering and/or Business Administration degree, or equivalent, required 7 - 10 years in technical Sales and experience in selling/engineering of technical products in an international environment, strongly desired Experience in planning, managing and coordinating customer and market strategies, preferred Excellent oral and written communication skillsAbility to read, write and speak English Demonstrated ability to problem solveExperience managing both small and large account Strong technical background, including technical terminology and conceptsIntercultural awareness Ability to work independentlyAbility to travel frequently, as required