17.07.2026 aktualisiert
100 % verfügbar
Senior Commissioning, Qualification, and Validation Consultant
Basel (CH), Schweiz
Weltweit
M.Sc. PharmaingenieurwesenSkills
Qualifizierung, Validierung, Commissioning, KNEAT, DALUX, UNIFIER, COMOS, DMS, MS Office, MS Outlook, SAP, LifeDoc, Basics, MS Excel, MS Word, MasterControl, Marzipan, KREDIS, MS PowerPoint, IBM Lotus, PowerPoint, FTIR, Internet, Master Control, Microsoft Outlook, Programmierung in der Sprache R, IBM Notes, Microsoft Excel, Microsoft Powerpoint, Microsoft Word, CSV, GAMP 5, 21 CFR part 11
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherFranzösischMuttersprache
Projekthistorie
• Supported the delivery and qualification of the K Building, a six-story GMP manufacturing facility at Bachem (Bubendorf, Switzerland), comprising upstream and downstream production areas
• Executed commissioning and qualification activities for critical process equipment, including bioreactors, filter dryers, media reactors, heating and cooling systems, and GMP production rooms.
• Performed and documented hydrogen peroxide (H₂O₂) pipe cleaning and decontamination across multiple process floors in accordance with GMP requirements
• Executed media system commissioning and supported the startup and operational readiness of process utility systems
• Conducted live parameter verification and functional testing of heating and cooling systems during commissioning
• Performed Installation Checks (IK), Functional Checks (FK), Installation Qualification (IQ), and Operational Qualification (OQ) for process equipment, utility systems, and manufacturing areas
• Executed and documented cleaning validation activities for bioreactors to ensure GMP compliance and validated cleaning effectiveness
• Applied and enforced Lockout/Tagout (LOTO) procedures to ensure safe execution of commissioning and qualification activities
• Collaborated with Engineering, Automation, QA, Validation, and Production teams to support system handover, GMP compliance, and project milestone achievement
Commissioning & Qualification
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Conducted the full CQV life-cycle (FAT → SAT → IQ/OQ/PQ) for eight fully-sterile, high-End filling lines (including: debagger, 2-chamber vial filler, isolator, capper, etc.).
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Qualified critical utilities such as HVAC, Pumptrolleys
Computer System Validation (CSV) – 21 CFR Part 11 / EU Annex 11 / Annex 1
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Validated SCADA & HMI platforms (Wonderware, WinCC) for 70+ automated systems; enforced data-integrity controls (Software, user access,)
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Performed line-to-line SCADA/HMI code comparisons with Beyond Compare & OP-Lexikon
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Performed DQ/IQ/OQ/PQ documentation activities.
Design Review & Engineering Oversight
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Reviewed 300+ P&IDs, architectural & electrical drawings against GMP, ISPE baseline guides and cGMP risk assessments (GAMP 5).
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Managed component-Check testing (I/O loop checks, PID tuning, servo drives) for 1,200+ tags; reduced SAT schedule by 15 %.
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Conducted BOR HMI Check for 4000 + Parameters
Tools & Systems:
SCADA (Wonderware, WinCC), SAP QM, D3, MS Office 365, OP-Lexikon, Beyond Compare, ValGenesis
Performed activities:
- Creation of the validation documentation regarding:
- the modifications of a Sterile Filling Line in a Restricted Access Barrier System (RABS) according to Annex 1 requirements.
- The modifications of a Clean Room class B
- Requalification of a semi-automatic visual inspection system Seidenader after a software update as well as CSV Part
- Document created: URS, RA, FMEA, DQ, IQ, OQ and PQ