Commissioning, Qualification & Validation Professionals – Switzerland

Role

Full-time

Permanent

Mid

Engineering

Logistics

Visp, Valais

Requirements

EU/EFTA permit

Skills

Drug substance manufacturingKNEATAseptic processingVeevaAutomationComputerized System ValidationCleanroom processesHVACTemperature mappingGMP-regulated systemsQualification AuditsValidation

Languages

English

German

French

Description

We welcome applications from professionals with experience in one or more of the following areas:

Commissioning and Qualification leadership
Clean and black utilities
HVAC and cleanrooms
Drug substance and drug product manufacturing
Fill-finish and aseptic processing
Buffer and media preparation
CIP and SIP systems
Upstream and downstream process equipment
Laboratory and analytical equipment
Automation and Computer System Validation
Thermal mapping
Qualification documentation and document generation
Quality Assurance and validation oversight
KNEAT, Veeva or other electronic validation systems

Responsibilities

Developing and implementing commissioning and qualification strategies
Preparing, reviewing and executing lifecycle documentation
Supporting DQ, FAT, SAT, commissioning, IQ, OQ and PQ activities
Reviewing URS, specifications, risk assessments and traceability matrices
Managing deviations, punch items and qualification close-out
Coordinating with engineering, quality, automation, vendors and operations teams
Providing technical leadership across assigned systems or workstreams
Supporting inspection readiness and compliance with applicable GMP requirements

Requirements

Experience within pharmaceutical, biotechnology or other regulated manufacturing environments
Practical commissioning, qualification or validation experience
A strong understanding of GMP requirements and the project lifecycle
The ability to work effectively with multidisciplinary and international teams
Strong technical documentation and communication skills

Tech stack

KNEATVeevaGMP

Benefits

Opportunity to work on technically challenging projects with leading life-sciences organisations
Supported by an experienced international team

Company

Kinetics Process Consulting GmbH

Pharmaceuticals

KPC International has supported pharmaceutical and biopharmaceutical projects worldwide since 2001. Our teams provide specialist engineering, commissioning, qualification, validation and project delivery services from concept through start-up and operation. We offer the opportunity to work on technically challenging projects with leading life-sciences organisations, supported by an experienced international team.