We are seeking a Principal Medical Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/2.7.2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.
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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
In Deinem Job: Programmierst und optimierst Du Workflows, Datenentitäten, Reports und Formulare in X++ sowie andere für D365 F&SCM spezifische Technologien. Setzt Du aktuelle Entwicklungswerkzeuge wie Azure DevOps, Visual Studio, GIT sowie KI-gestützte Programmierassistenten ein.
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 Achieve planned KPIs (sales, new opportunities) via sufficient order incomeElaborate Sales plans, forecasting and performance reportsPlan, direct and coordinate customer strategies and activitiesManage Key Accounts (local OEMs)Setup and execute regular customer visitation schedules and visits in CRMGenerate inquiries from customers and related quotations with support of Customer Service and other internal entitiesAuthorize quotations and pricing; perform reviews, negotiations, and contracting with customersHandle customer complaints with the support of Inside Sales and Quality departmentAssist A/R with overdue managementDocument customer knowledge in CRMFoster new growth opportunities with new customers, products, applications and projectsDrive competitive intelligence and reports to Market Intelligence teamEstablish sound market and application knowledgeContinously improve the overall customer satisfaction along the customer journeyEnsure teamwork and alignment of goals and objectives Follow Company policies and protocols, while adhering to all safety guidelines Follow Company Code of Conduct, Core Values and applicable laws and regulationsParticipate in trade shows, exhibitions and conferences, when applicable Attend both internal and external trainings Your Profile Masters Degree in Engineering, Science or Business Administration, required Minimum 5 years in Key Account Management, required Technical Sales/Marketing or Product Management of high engineesring content materials and components in an industrial Business-to-Business (B2B) environment, strongly preferredExperience in the semiconductor industry and/or quartz glass material sales, strongly desired Ability to read, write and speak English; strong oral and written communication skillsProficiency in MS Office knowledgeAbility to work in a dynamic and fast growing industryGrowth and results driven mindsetPersonable with excellent people management and teamwork skillsAbility to work in a global, matrix organization 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 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
. • Completes labor sheets, routers, log sheets, process forms and similar reports and forms. • Performs basic maintenance on production machinery and equipment. • Follows established process specifications and procedures. • Complies with all company policies and procedures. • Maintains housekeeping practices per departmental 5S program. • Meets utilization targets and standard times. • Accurately enters Database/SAP transactions in the computer. • Maintains daily records, including labor sheets and routers. • Responsible for observing and following all Environmental, Health and Safety rules and procedures.
Erkennst Du durch Deine enge Kundenbeziehung proaktiv Erweiterungspotenziale und schlägst Lösungen und Dienstleistungen aus unserem E2E-Portfolio vor. Programmierst und optimierst Du Workflows, Datenentitäten, Reports und Formulare in X++ sowie andere für D365 F&SCM spezifische Technologien. Setzt Du aktuelle Entwicklungswerkzeuge wie Azure DevOps, Visual Studio, GIT sowie KI-gestützte Programmierassistenten ein.
Erkennst Du durch Deine enge Kundenbeziehung proaktiv Erweiterungspotenziale und schlägst Lösungen und Dienstleistungen aus unserem E2E-Portfolio vor. Programmierst und optimierst Du Workflows, Datenentitäten, Reports und Formulare in X++ sowie andere für D365 F&SCM spezifische Technologien. Setzt Du aktuelle Entwicklungswerkzeuge wie Azure DevOps, Visual Studio, GIT sowie KI-gestützte Programmierassistenten ein.
Your assignments Leading multidisciplinary and multicultural project teamsManagement of several urban water projectsResponsibility for studies, design, tender documents and construction supervision for different investment measures in the field of water, wastewater and solid waste (2 out of 3 fields)Liaison and communication with Clients and Donor AgenciesManagement of technical deliverables and reportingPredict resources needed to reach objectives and manage resources in an effective and efficient mannerPrepare and track project budgets based on scope of work and resource requirementsTrack, follow up and report on invoicingDevelop and manage a detailed project schedule and work plan for a portfolio of projectsProvide project updates on a consistent basis to management and external stakeholders about strategy, adjustments, and progressPrepare and manage contracts with subcontractors and suppliersUtilize industry best practices, techniques, and standardsMeasure project performance to identify areas for improvementManage preparation of PQsManage and write technical and financial proposals, bring proposals through the approval process Your profile University degree (M.Sc.) in civil engineering, mechanical engineering, process or environmental engineering or other suitable qualificationPreferably 15 years of professional experience in international consulting / engineering in the field of urban water managementSeveral years of experience in project management, project control (backstopping) and in dealing with international donor organizations and development banksConfirmed successful acquisition of consulting projectsVery good leadership, team development and communication skillsVisionary thinking skills and the ability to support and shape a developing department and teamBe actively involved in professional activities, conferences, committees in the industryWillingness to travel extensivelyVery good knowledge of the English language, spoken and written and preferably in an additional business language (French, Spanish, etc.)Proficiency with Project Management software preferredStrong interpersonal and technical writing skillsPreferably additional qualifications in project management (PMI or similar) We offer Permanent positionFlexible working environment (mobile office/office hours)Friendly and collaborative spirit in multidisciplinary teamsHigh degree of personal responsibilityFinancial benefits (e.g. participation in corporate success)Challenging projects, where you can develop both professionally and personallyMultiple internal and external training opportunitiesCanteen nearby (meal allowance)Office amenities (e.g. company sports, free water, coffee and tea) Please send your application to Christina Müller.
. • Three to five years related manufacturing experience is preferred • Ability to read and interpret documents such as safety rules, customer drawings, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively to all levels of management and employees. • Be able to calculate figures and amounts such as proportions, percentages, measurements, area, circumference, and volume
. • Three to five years related manufacturing experience is preferred • Ability to read and interpret documents such as safety rules, customer drawings, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively to all levels of management and employees. • Be able to calculate figures and amounts such as proportions, percentages, measurements, area, circumference, and volume
. • Three to five years related manufacturing experience is preferred • Ability to read and interpret documents such as safety rules, customer drawings, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively to all levels of management and employees. • Be able to calculate figures and amounts such as proportions, percentages, measurements, area, circumference, and volume
. • Three to five years related manufacturing experience is preferred • Ability to read and interpret documents such as safety rules, customer drawings, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively to all levels of management and employees. • Be able to calculate figures and amounts such as proportions, percentages, measurements, area, circumference, and volume
Software Implementation Implement software for new and existing products according to design and coding principles Write effective and comprehensive unit tests Perform integration activities on target hardware and integrate generated code Software Validation & Verification Validate and verify software from unit tests through to flight tests Ensure all requirements are verified in line with program needs Produce test reports to support product release, qualification, and certification Contribute to the overall V&V strategy Release Management & Planning Develop release plans aligned with system development and customer needs Ensure timely availability of releases to customers Follow defined release management processes Software Definition & Design Collaborate with systems engineering and customers to capture high-level software requirements Produce and maintain complete software design documentation for DeckFinder products Define high-level and low-level software requirements Contribute to the overall design strategy Team Contribution Support engineering planning and process improvements Participate in global technical sales support activities Join trials teams for safe and effective deployment of DeckFinder and test assets Qualifications & Requirements Education Bachelor’s degree (or higher) in Computer Science or related field Professional Experience Minimum 4 years in IT/Information Systems Proven experience in software engineering across V-Model responsibilities Strong track record in developing unit and integration tests Experience with airborne systems and DO-178B/C compliance is a plus Technical Skills Proficiency in C (mandatory) Embedded software development expertise (scheduler, U-Boot, firmware, I/O) Experience with MISRA-C standards Working knowledge of Xilinx ARM Cortex SoC Knowledge of C++ (QT), Python, MATLAB/Simulink is a plus Familiarity with Lauterbach Embedded Trace and debugger desirable Experience with Atlassian toolchain is nice to have Additional Skills Team player with a proactive mindset Ability to work in an international environment Strong analytical and problem-solving skills Languages Professional fluency in English (mandatory) German is an advantage Bei uns zählt die Qualifikation – unabhängig von Alter, Geschlecht, Behinderung, sexueller Orientierung/Identität sowie sozialer, ethnischer und religiöser Herkunft.
Identify non-conformities, recommend product and process changes, and initiate Fracas fault reports (FRNs). Chair and write up safety reviews. Support UL, CSA and Semi S2 inspections. Conduct EMC emission measurements and support EMC immunity testing.
Champion consistent use of brand guidelines and support colleagues in embedding them. Support the delivery of key corporate reports, including our Annual Report. Help organise and deliver major events such as the annual Leadership Conference. What you’ll bring You’ll be someone with the ability to translate complex information into clear, engaging messages.
Key Responsibilities: ·Provides specialized administrative support in the development, implementation, and marketing of our two HR development programs ·Serves as a central point of contact between prospective employees, vendors, staff, other departments, and/or external constituencies on day-to-day operational, and administrative matters; assists with meetings, special projects, and/or general problem resolution ·Coordinates activities and administration of program objectives; this requires engaging internal and external stakeholders ·Monitors and administers program/project expenses; may develop or participate in the development of funding proposals for the program ·Writes, edits, and coordinates development of course catalogs, promotional materials, educational materials, training manuals, newsletters, and/or brochures, as appropriate to the program ·Maintains program/project records, researches information and gathers and computes various data; prepares special and/or one-time reports, summaries, or replies to inquiries, selecting relevant data from a variety of sources. ·Performs miscellaneous job-related duties as assigned Skills / Requirements: ·Sophomore, Junior, or Senior level college student seeking an HR degree ·Advanced knowledge of Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint) ·Very strong presentation and communication skills ·A very motivated individual who takes initiative and can work independently with minimal supervision ·Strong multi-tasker with ability to take direction from multiple sources WHY JOIN our DHL team?