Plant and CAPEX engineer

Production (USP and DSP) and clean utilities maintenance planning; CAPEX management till 500K CHF;

Requalification and qualification activities (FAT-SAT-IQ-OQ) for USP/ DSP/Clean Utilites equipment/process. Smoke studies preparation and execution supervision for qualification activities.

Technical Change Request coordinator; daily use of SAP, Excel, COMOS, DMS, TrackWise, GMP standards.

Experience with Swissmedic audit for production license.

Daily and weekly alignment with Department stakeholders to discuss Technical Changes related to all BioAtrium departments.

Civil-Structural-Architectural Handover Engineer (administrative, Labs, production and classified clean room (E-D-C) areas)

Qualification document civil department. Definition of standard documentation for clean rooms and labs. CTOP, VTOP, ETOP documental review support (KNEAT)

Work and contractors supervision. Direct interface with client for revamping/changes requests, local contractors management and internal QA audit on executed works.

Responsible for quality, schedule, costs of all assigned CSA sub-systems. CSA completion walk-downs and safety walk-downs execution.

Integral test planner and executor for final building occupancy // Inspections with GVB for final building acceptance

Fire protection requirements construction supervisor

Coordination of all process relevant activities incl. review and approve process engineering specifications, including process piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for quipment and systems.

Close collaboration with all project discipline (incl. Contactors), key Project & Site stakeholders and project managers.

Interface with stakeholders to ensure the design execution and delivery are in accordance with Global Engineering, Quality, Environmental and Safety procedures.

Integral test planner and executor for final building occupancy.

Inspections with SGV, AWA/SUVA, AfU for final building acceptance (fire protection approval for the building insurance, environmental office and work insurance department)

Fire protection requirements construction supervisor (QS brandschutz support).

Compliance supervision according to local and European fire protection directives (VKF/AEAI – FM global for sprinkler system).

TUV Sud Basel consultant support on machinery directive procedures for documental compliance with MD 2006/42/EC and 2014/68/EU and EKAS requirements.

Scheduler and coordinator for cantonal inspections (AWA, SUVA, SGV, FM global, AfU).

Lightning protection system coordination for final cantonal approval.

URS definition for clean utilities production plant revamping (Ultrafiltration system, Softened water system, Purified water system (double stage reverse osmosis equipment ), Water for injection (5 stages distillator equipment), clean steam generator. Clean gasses (CO2, O2, N2, He) storage and distribution.

Clean utilities installation (FAT/SAT) and qualification (IQ,OQ) execution and supervision.

Instrument calibration planning and supervision (support to relevant project manager)- KAYE validator for temperature mapping.

Performance qualification (PQ) supervision, GMP deviations and gap assessment execution for all the equipment and relevant mechanical interconnections related to the clean utilities mentioned above according to GMP, FDA and AIFA requirements.

Commissioning supervision. PW (purified water), WFI (water for injection) loops sanification process tuning during IQ-OQ using Delta-V and OSI PI software.

Monitor external service providers, participate in internal audits, and serve as SME for production issues.

Capture and maintain consistent data on technical systems (spare parts lists, operating instructions, Clean utilities SOPs creation, technical documentation request and revision)

Clean utilities maintenance department : activity planner, Start up/shut down scheduler, spare part list creation and client support with vendors’/suppliers’ contact for ordinary and not-ordinary maintenance.

Pressurized equipment compliance check with D.M. 329/2004, 97/32/CE (P.E.D.) and D.Lgs. 26/2016 – ISO 9001 and 2014/68/EU.

Equipment and assembly of machineries authorities registration according to D.Lgs. 17/2010.

Compliance, design and revamping of pressurized equipment (ASTM e ISPESL directives, ASME for piping and equimpent).

Operating manuals creation for equipment according to machinery directive (D.Lgs 17/2010) and 2006/42/ European directive.

Execution of risk analysis according to local D.Lgs. (81/2008) and EN 12100.