Senior Automation Engineer

K-Recruiting Life Sciences; Werthenstein; On-site; CHF 120,000 - 180,000; Full time

Job summary

K-Recruiting Life Sciences seeks an experienced Automation Specialist for GMP manufacturing. You will act as a subject matter expert for control strategies on new equipment, implementing DeltaV, PAS-X, and Ignition systems to streamline production and administrative processes.

The role requires 5+ years in automation within biologics/pharma, strong validation knowledge (GAMP 5), and excellent English communication. On-site with possible off-shift support as needed.

Qualifications

• Bachelor’s degree in Life Science or equivalent practical experience.
• 5+ years in automation controls in GMP environments.
• Solid understanding of validation/SDLC (GAMP 5).
• Excellent written and spoken English (C1).

Responsibilities

• Serve as a SME for control strategies for new equipment in GMP manufacturing.
• Implement technologies and instruments to streamline processes and reduce effort.
• Provide automation support for DCS (DeltaV), MES (PAS-X), SCADA (Ignition).
• Troubleshoot automation issues to boost manufacturing performance and maintain cGMP compliance.
• Lead deviations investigations and implement CAPAs.
• Collaborate with Quality, Validation, and Operations to resolve problems.
• Support Digital Transformation projects with system integrations and data analytics.

Education

Bachelor’s degree in Life Science

Tools

DeltaV

PAS-X

Ignition

Kneat eVal

OPC/Profinet/Modbus networking

Job description

• 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.

Qualification:

• 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.
• Basic knowledge and/or working with an MES system (PAS-X, Syncade, Ignition MES) is advantageous.
• Commissioning and qualification, test protocol development and execution in Kneat eVal.