Erfahrungen im Bereich Cleanroom wünschenswertErfahrung im Bereich beratungsintensiver Dienstleistungen und ProdukteSehr gute Deutsch- und gute EnglischkenntnisseStarke Kunden- und Serviceorientierung sowie ausgeprägtes Verhandlungsgeschick und ÜberzeugungskraftProaktiver Umgang mit Aufgaben und Herausforderungen Hohe Eigenmotivation und Identifikation mit dem Job und dem UnternehmenKreative Denkweise, um neue Ideen einzubringen und die Entwicklung der Kunden voranzutreibenSehr gute Kommunikations- und Interaktionsfähigkeiten mit beratendem AnsatzAnalytische Fähigkeiten, um Geschäftsanforderungen in Taten umzusetzenHohe Eigenmotivation und ausgeprägte TeamfähigkeitReisebereitschaft 2-3 Tage pro WocheMS Office-/Salesforce-Kenntnisse
Reisebereitschaft: Du bist bereit, 2–3 Tage pro Woche zu reisen. IT-Kenntnisse: Du verfügst über sichere MS‑Office-Kenntnisse
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