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.), Warehouse

Job 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.

DESCRIPTION:

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 Fisher’s 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

• Bachelor’s degree (FH/University) in Engineering, Business Administration, Life Sciences, or a related field; Master’s 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