Industry: Pharmaceutical Manufacturing

About the Role

We are seeking a motivated, technically skilled, and communicative System Engineer to take ownership of our AVEVA PI Data Historian and Rotronic Monitoring Systems (RMS).

In this critical role, you will act as the System Owner for both platforms, ensuring their reliable operation in a highly regulated GMP environment. You will work closely with manufacturing, engineering, quality, automation, and IT teams while driving system improvements, compliance activities, and strategic projects.

This is an excellent opportunity for a hands-on engineer who combines strong technical expertise with leadership capabilities and enjoys working in a complex pharmaceutical production environment.

Key Responsibilities

System Ownership & Operations

• Serve as the System Owner for AVEVA PI and Rotronic Monitoring Systems (RMS)
• Ensure reliable operation and lifecycle management of both systems across the Basel and Kaiseraugst sites
• Manage system performance, availability, maintenance, and continuous improvement activities

Compliance & Validation

• Create, review, and maintain validation and qualification documentation
• Ensure compliance with GMP, GxP, CSV, and internal quality standards
• Support audits and inspections and coordinate remediation activities where required

Incident, Change & Service Management

• Lead Incident, Problem, Change, and Deviation Management processes
• Coordinate service providers and internal stakeholders to ensure timely issue resolution
• Drive continuous service improvements and operational excellence

Projects & Engineering

• Lead and contribute to system-related projects and upgrades
• Implement and configure equipment interfaces to the AVEVA PI platform
• Connect manufacturing and laboratory equipment to the production domain via Active Directory
• Collaborate closely with automation, manufacturing, quality, and IT teams

Required Qualifications

Education

• Degree, Technician Certification, or completed vocational training in:
  • Computer Science / Information Technology
  • Automation Engineering
  • Electrical Engineering
  • Or a comparable technical discipline

Technical Expertise

• Strong hands-on experience with the AVEVA PI Platform
• Advanced knowledge of PI System configuration and interface implementation
• PI Certification is considered a strong advantage
• Experience with PLC and Process Control Systems, preferably Siemens S7
• Experience with Computerized System Validation (CSV) and IT Qualification
• Good understanding of Active Directory environments
• Experience working in regulated pharmaceutical manufacturing environments

Professional Experience

• Proven experience within Pharmaceutical Production and GxP-regulated environments
• Experience in Project Management
• Strong understanding of system lifecycle management and compliance requirements
• Experience managing cross-functional stakeholders and vendors

Personal Skills

• Strong communication and stakeholder management skills
• Highly developed matrix leadership capabilities
• Structured, solution-oriented, and proactive working style
• Ability to work independently while collaborating effectively within interdisciplinary teams

Languages

• Fluent German (spoken and written)
• Fluent English (spoken and written)

What Makes You Successful

You combine deep technical expertise in industrial data historian systems with a strong understanding of validation and compliance requirements in the pharmaceutical industry. You are comfortable operating across engineering, quality, manufacturing, and IT functions and can effectively lead initiatives in a matrix organization while maintaining a hands-on approach to problem-solving.

If you are passionate about digital manufacturing systems, data integration, and ensuring operational excellence in a highly regulated environment, we would love to hear from you.