07.11.2025 aktualisiert
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Project Manager | Bioprocess & CAPEX Projects | GMP Validation Expert
Berlin, Deutschland
Weltweit
MSc in Business Management, Mtech in BiothechnologyÜber mich
Project Manager with 5+ years delivering complex CAPEX, CMC, and validation projects in GMP-regulated biopharma and CDMO environments. Expert in bioprocess equipment installation, PPQ, facility commissioning, and regulatory documentation for aseptic processing and single-use technologies.
Skills
Six SigmaForschungChromatographieAgile MethodologieData AnalysisZellkulturenAsanaAsepsisAtlassian JiraAuditsAutomatisierungBioprozessBioreaktorenReinraumKundenbeziehungsmanagement
Technical Project Management & CAPEX Leadership:
• Bioprocess engineering project leadership: equipment procurement (chromatography skids, bioreactors, centrifuges, clean utilities WFI, CIP/SIP), automation system integration (SCADA, DCS)
• CAPEX lifecycle management: conceptual design, URS, FAT/SAT execution, IQ/OQ/PQ
• Upstream/downstream processing: mammalian cell culture, biosimilars, tangential flow filtration (TFF), chromatography systems, viral inactivation, buffer preparation
Validation & GMP Compliance:
• Coordination of validation lifecycle deliverables within GxP frameworks: VMP, protocol review, batch record audits, deviation investigation
• Process validation and commissioning: PPQ, facility commissioning, cleanroom qualification
• Regulatory compliance: FDA, EMA, ICH Q7, Annex 1, cGMP, aseptic processing, single-use technologies
Methodologies & Process Optimization:
• Lean, Six Sigma (Green Belt), Kaizen methodologies, DMAIC tools
• Risk-based approaches: FMEA, HAZOP
• Agile, Scrum project management
Stakeholder & Vendor Management:
• Cross-functional team leadership and coordination
• Vendor and subcontractor management
• Technology transfer and scale-up/tech transfer
Tools & Systems:
• Project Management: Asana, Smartsheet, Jira, MS Project
• CRM & Business: Salesforce, Hubspot, Zoho, Borealis
• Data Analysis: Tableau, Power BI, Excel, SAP S/4HANA
Sprachen
DeutschGrundkenntnisseEnglischMuttersprache
Projekthistorie
• Managed complex CAPEX and process enhancement projects for consulting clients including Guidepoint, AlphaSights, L.E.K. Consulting
• Established comprehensive project schedules integrating engineering, validation, QA, and operations milestones
• Oversaw FAT/SAT coordination with vendors for bioprocess skids and clean utility validation
• Delivered CQV documentation packages ensuring GMP compliance and audit readiness
• Led bioprocess equipment upgrade projects for chromatography and buffer prep systems within cGMP frameworks
• Facilitated cross-functional risk assessment using FMEA and structured change control
• Achieved cost savings through supplier rationalization and optimized CQV scheduling
• Supported validation teams on protocol creation per Annex 1 standards
• Directed installation and qualification of single-use filtration and tubing assemblies in aseptic cleanrooms
• Controlled validation lifecycle including FAT, IQ/OQ/PQ and cleaning validation
• Managed vendor quality assurance and corrective action reporting