Operational Excellence Site Specialist (GMP) BaselAllschwil
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Job Location:
Arlesheim - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) WarehouseJob Description
Operational Excellence Site Specialist (PPI Business System Specialist II)
Join our Pharma Services Group (PSG) team and be part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development clinical trial logistics and commercial manufacturing. Biotech and biopharma companies rely on us for speed flexibility and quality across every phase of development.
Our Clinical Trials Division (CTD) supports pharmaceutical biotechnology and contract research organizations (CROs) in conducting efficient and successful clinical trials. Our teams provide comprehensive clinical supply chain services including packaging labeling and distribution.
You will join our Basel site a Clinical Label Services (CLS) production facility specializing in clinical label design print production inspection reconciliation and global distribution for the pharmaceutical and biotechnology industry.
We are seeking a motivated and execution-oriented Operational Excellence Specialist (PPI Specialist) to support operational readiness process robustness and compliance performance at our Basel CLS production site.
In this GMP-regulated production environment you will play an active role in strengthening process stability improving right-first-time performance reducing operational variability and reinforcing disciplined execution across the site.
This role supports deployment of Thermo Fishers Practical Process Improvement (PPI) Business System and leverages structured quality mechanisms including Change Control and CAPA processes to implement sustainable improvements enhance compliance and reduce reactive workload.
Key Responsibilities
Drive operational excellence initiatives to improve production stability process flow execution discipline and sustained GMP compliance within the CLS production environment
Strengthen operational readiness by enhancing documentation practices process adherence and standardized execution across production workflows
Support compliance performance by reinforcing process control reducing variability and ensuring alignment with GMP and regulatory requirements
Utilize Change Control and CAPA processes as structured improvement mechanisms to formalize and sustain operational enhancements
Identify and address systemic operational gaps contributing to rework recurring deviations execution instability or compliance risk
Strengthen upstream process controls to reduce downstream disruptions in label design print production inspection and reconciliation
Ensure disciplined implementation of operational changes to minimize unintended impact and maintain controlled execution
Apply structured problem-solving methodologies (Lean Six Sigma root cause analysis) to eliminate inefficiencies and enhance process robustness
Implement and sustain 5S and visual management practices within production areas to improve transparency and accountability
Leverage Microsoft Power Platform tools (Power Automate Power Apps Power BI) to enhance process visibility automate tracking and strengthen operational data integrity
Develop and maintain KPI dashboards covering right-first-time performance rework trends cycle time throughput and operational event patterns
Facilitate team-level improvement workshops and support Kaizen initiatives aligned with operational and compliance priorities
Develop process maps standard work documentation and job aids reflecting disciplined execution practices
Collaborate cross-functionally with Production Planning Engineering Client Services Quality and Site Leadership to ensure execution consistency
Support sustainment of implemented improvements through follow-up activities performance monitoring and accountability measures
Requirements
Bachelors degree (FH/University) in Engineering Business Administration Life Sciences or a related field; Masters degree preferred
Minimum 5 years of experience in operational excellence process improvement or production operations within a GMP-regulated pharmaceutical biotechnology or clinical supply environment
Demonstrated experience driving operational improvements that strengthen compliance and reduce recurring deviations
Lean Six Sigma Green Belt certification preferred
Strong understanding of GMP-regulated production environments (EU GMP experience advantageous)
Experience using Change Control and CAPA processes to drive structured and sustainable process improvements
Proficiency with Microsoft Power Platform (Power Automate Power Apps Power BI)
Experience implementing and sustaining 5S and visual management systems
Strong analytical and structured problem-solving capabilities with a disciplined execution mindset
Ability to influence cross-functional stakeholders without direct reporting authority
Experience in clinical supply chain or clinical label production environments advantageous
Professional proficiency in English and German required
Required Experience:
IC
Key Skills
About Company
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