Senior Automation Engineer

Randstad Switzerland; Luzern; Hybrid; CHF 120,000 - 150,000; Full time

Job summary

Randstad Switzerland is seeking a Senior Automation Engineer for an international pharmaceutical company. The role focuses on dedicated automation support, evaluation and implementation of process controls for new equipment and processes within biologics development and clinical manufacturing.

You will join the Biotech Process Automation team, drive DeltaV/MES transitions, verify cGMP compliance, and contribute to continuous improvement projects.

Qualifications

• Bachelor's degree in Life Science or equivalent practical experience in automation controls.
• Strong knowledge of computer validation and validation lifecycle (GAMP5).
• Excellent written and verbal English communication (C1).
• Proven experience with DeltaV batch design and control strategy implementation.

Responsibilities

• Provide automation support for GMP manufacturing systems and processes.
• Lead design, testing, installation, qualification and training of automation solutions.
• Implement and optimize DeltaV, MES, SCADA and related control systems.
• Support continuous improvement efforts and technology transfers.

Skills

DeltaV expertise

GAMP5 knowledge

cGMP experience

Education

Bachelor's Life Science or equivalent

Tools

DeltaV

PAS-X

Ignition

Job description

For one of our clients, an international pharmaceutical company, we are seeking a Senior Automation Engineer.

General Information:

• Duration: 1 year
• Extension: to be discussed
• Home office: to be discussed

About the job:

The Senior Automation Engineer will provide dedicated automation support, evaluation and implementation of process controls for novel equipment, innovative processes, and the implementation of next generation technologies to keep our Company at the forefront of innovation in development and clinical manufacturing of biologics. The Senior Automation Engineer will be responsible for troubleshooting in compliance with cGMPs of various manufacturing systems within our biotechnology facility and actively contribute to continuous improvement projects for the development and clinical manufacturing of biologics as part of the Biotech Process Automation team in the Technology and Engineering Department.

The Biotech Process Automation team provides a strategic link between our early and late-stage pipeline and is responsible for developing and maintaining the "Line of Sight" for new technology and innovative processes. As part of a scale-out philosophy, the Senior Automation Engineer will support DeltaV / MES Recipe and Technology Transfers and alignment from Process Development to the local site and then to our late-stage BioNX Facility in Ireland.

Tasks & responsibilities:

Responsibilities will encompass all phases of a project life-cycle including concept requirement, design, testing, installation, qualification and training.

• Inspire Diversity and Inclusion - building effective working relationships within a cross-functional team across different cultures and backgrounds.
• Serve as a Subject Matter Expert for the implementation of control strategies for new equipment to enhance manufacturing processes in a Good Manufacturing Practice (GMP) environment.
• Implement innovative technologies, software, control strategies, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processes.
• Provide key automation support for various manufacturing systems such as DCS (DeltaV), MES(PAS-X), SCADA (Ignition), and OEM systems.
• Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation.
• Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP.
• Transfer of Process Technologies from early-stage pipeline facilities and drive to GMP
• Operational Status, and support line of sight to commercial supply.
• Lead automation related investigations into deviations and implement corrective actions.
• Working with external companies, organizing spare parts and service visits.
• Supporting the qualification of new systems. Write, review, and/or execute test documents.
• Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problems.
• Participate and actively support Digital Transformation initiatives involving system integrations, data connectivity, data analysis/modelling, validation methods and value-based optimization of manufacturing via process control system.
• Limited off shift work may be required to meet project, operations, and qualification needs.

Requirements:

• Bachelor's degree in Life Science discipline or equivalent practical experience of at least 5 years of experience in automation controls.
• Thorough knowledge of computer validation/SDLC requirements and automation change control procedures. (e.g., GAMP 5)
• Effective oral / written communication skills in English (C1).
• Proven experience with DeltaV Batch design, implementation and test, including the ISA S95 and S88.
• Proven experience in DeltaV control strategy/Recipe implementation and administration for process equipment like Cytiva AktaRDY, AktaRDY XL, Sartorius Resolute BioSMB 80/350.
• At least 3 years of experience in Automation or Engineering function for Biologics, Food, Medical Devices, or pharmaceutical industries.
• Proven experience with development and implementation of industrial controls such as DCS (Delta V), MES (PAS-X), Historian (PI).
• I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, and ModBus protocols) is advantageous.