19.06.2026 aktualisiert


100 % verfügbar
Lead Process & Utilities Engineer (CAPEX / Pharma)
Neuheim, Schweiz
Weltweit
Master's in Process Engineering, TU DortmundÜber mich
I am a skilled Process Engineer with experience across Chemicals, pharmaceutical API production, sustainable technologies, and large-scale energy infrastructure projects in Switzerland, Germany and Europe. My work combines process design, C&Q, engineering coordination
Skills
Chemische GefährdungenChemische ReaktionstechnikComplianceVerfahrenstechnikFunktionale SicherheitPharma-EngineeringProzessdesignProzesssimulationThermische VerfahrenstechnikIq/oq/pqP&I LogaWasserstoffindustrieGmp-gerechte Dokumentation
GMP-Regulated Utilities & Sterile Manufacturing
Expertise in utilities for sterile and parenteral processing including Clean Steam, WFI, Purified Water, Nitrogen, and HVAC sterile interfaces. Preparation and review of URS, FS, DS, RA, IQ/OQ protocols, and FAT/SAT packages. Validation and qualification support for process and utility equipment.
CAPEX Project & Engineering Leadership
Lead engineer for brownfield and greenfield CAPEX projects across pharmaceutical, chemical, and energy sectors. Multidisciplinary coordination covering process, utilities, automation, piping, QA, and commissioning. Cost estimation, planning, scheduling, stakeholder and vendor management, and risk assessments including HAZOP/LOPA.
Process Engineering & P&ID Development
Execution of process engineering tasks across feasibility, design, and execution phases. Development and digitalization of P&IDs, mass and energy balances, and process utility specifications. Conducted HAZOPs, 3D model reviews, and process safety assessments.
Documentation & GMP Compliance
Creation of GMP-compliant documentation, SGU/HSE documentation, process and utility specifications, and P&IDs. Change control, deviation support, and compliance evaluations in regulated pharmaceutical and chemical environments.
Commissioning & Qualification (FAT/SAT, IQ/OQ)
Support of FAT/SAT preparations and commissioning activities. Ensuring IQ/OQ readiness for critical utilities and qualification-ready engineering deliverables.
Functional Safety Engineering (TUV SUD Certified)
Lead SIL-related safety activities as TUV SUD Certified Functional Safety Engineer. Experience working in compliance with Swiss industrial quality, safety, and regulatory requirements.
Process Simulation & Modeling
Application of simulation tools including ASPEN, CONVAL, HTRI, and COMOS for process modeling, optimization, and engineering data management. Master thesis in the field of Process Modeling and Simulation.
Plant Design & P&IDs
Plant design activities including development and review of P&IDs, process flow diagrams, and engineering deliverables for industrial CAPEX projects in refinery, pharmaceutical, and chemical sectors.
Expertise in utilities for sterile and parenteral processing including Clean Steam, WFI, Purified Water, Nitrogen, and HVAC sterile interfaces. Preparation and review of URS, FS, DS, RA, IQ/OQ protocols, and FAT/SAT packages. Validation and qualification support for process and utility equipment.
CAPEX Project & Engineering Leadership
Lead engineer for brownfield and greenfield CAPEX projects across pharmaceutical, chemical, and energy sectors. Multidisciplinary coordination covering process, utilities, automation, piping, QA, and commissioning. Cost estimation, planning, scheduling, stakeholder and vendor management, and risk assessments including HAZOP/LOPA.
Process Engineering & P&ID Development
Execution of process engineering tasks across feasibility, design, and execution phases. Development and digitalization of P&IDs, mass and energy balances, and process utility specifications. Conducted HAZOPs, 3D model reviews, and process safety assessments.
Documentation & GMP Compliance
Creation of GMP-compliant documentation, SGU/HSE documentation, process and utility specifications, and P&IDs. Change control, deviation support, and compliance evaluations in regulated pharmaceutical and chemical environments.
Commissioning & Qualification (FAT/SAT, IQ/OQ)
Support of FAT/SAT preparations and commissioning activities. Ensuring IQ/OQ readiness for critical utilities and qualification-ready engineering deliverables.
Functional Safety Engineering (TUV SUD Certified)
Lead SIL-related safety activities as TUV SUD Certified Functional Safety Engineer. Experience working in compliance with Swiss industrial quality, safety, and regulatory requirements.
Process Simulation & Modeling
Application of simulation tools including ASPEN, CONVAL, HTRI, and COMOS for process modeling, optimization, and engineering data management. Master thesis in the field of Process Modeling and Simulation.
Plant Design & P&IDs
Plant design activities including development and review of P&IDs, process flow diagrams, and engineering deliverables for industrial CAPEX projects in refinery, pharmaceutical, and chemical sectors.
Erfahrung
Berufserfahrung0 - 5 Jahre
Freelancer seit2026
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicher
Projekthistorie
At Bachem AG, Bubendorf, I have been actively involved over a period of 2.5 years in the delivery of projects within the newly constructed Building K facility, a state-of-the-art production plant dedicated to the manufacturing of Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical market.
Building K represents a significant expansion of Bachem’s production capabilities, designed to meet increasing demand for high-quality peptide and API manufacturing under strict GMP conditions. My role has been centered around Commissioning & Qualification (C&Q) activities across multiple critical systems and sub-projects.
Currently, I am involved in the Downstream HPLC purification unit, a critical component in API production for achieving high product purity.
Current phase:
- Site Acceptance Testing (SAT)
Upcoming Phase:
IK/IQ/OQ Phase
Responsibilities:
- Working closely with the package unit supplier to execute and document SAT procedures
- Ensuring all technical and functional requirements are met prior to handover
- Supporting readiness for transition to operations and GMP-compliant production
- Mechanical and Functional completion of the package unit
- Change Request and Change Management.
At Corden Pharma, Schweizerhalle (Switzerland), I was involved in engineering activities for an API production facility, which has since been placed on hold. The facility was designed to support high-quality pharmaceutical manufacturing under stringent GMP and regulatory standards, requiring robust process utilities, environmental control systems, and sustainable waste handling solutions.
In this project, I took on a Process Utility Design role on the client side, contributing to multiple critical engineering and design workstreams.
Key Responsibilities & Contributions:
Process Utility Design Lead (Client-Side):
Led the design and coordination of process utilities, ensuring alignment with project requirements, operational needs, and regulatory compliance.
Functional Requirement Specifications (FRS):
Prepared detailed Functionality Requirement Specifications (FRS) to define system behavior, performance expectations, and design criteria for various utility and process systems.
HVAC Design Support:
Provided client-side engineering support for HVAC systems, contributing to cleanroom requirements, environmental control, and GMP-compliant air handling design.
Waste Management Concept Development:
Designed a comprehensive waste management strategy, including handling, treatment, and disposal concepts for liquid and gaseous waste streams.
At Bachem AG, Bubendorf, I have been actively involved over a period of 2.5 years in the delivery of projects within the newly constructed Building K facility, a state-of-the-art production plant dedicated to the manufacturing of Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical market.
Key Project & ResponsibilitiesTank Farm (Tanklager) & Utility Distribution Project
I played a key role in the commissioning and qualification of the solvent and waste tank farm, including the associated utility distribution network.
Scope included:
- Storage and handling systems for solvents and waste streams
- Utility distribution pipelines (process and clean utilities)
- Associated equipment, piping systems, and technical rooms
Core contributions:
- Conducted system walkdowns to ensure installation compliance and readiness for commissioning
- Actively participated in HAZOP studies, contributing to safe and compliant system design
- Supported and executed FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests) for equipment and systems
- Collaborated closely with the C&Q team to ensure:
- Adherence to project timelines
- Smooth commissioning execution
- Qualification in line with GMP standards and regulatory requirements