Senior Automation Engineer

CK QLS; Luzern; On-site; CHF 110,000 - 150,000; Full time

Job summary

CK QLS in Luzern, Switzerland seeks a Senior Automation Engineer to provide dedicated automation support and implement advanced control strategies for new equipment in a GMP biotech setting. You will troubleshoot and improve manufacturing systems, support DeltaV, MES (PAS-X), and SCADA (Ignition), and drive technology transfers toward GMP readiness.

Ideal candidates have a life science degree with 5+ years in automation, strong validation knowledge (GAMP 5), and excellent English communication.

Qualifications

• Bachelor's degree in Life Science or equivalent practical experience.
• 5+ years of experience in automation controls.
• Strong knowledge of validation/SDLC and change control (GAMP 5).
• Excellent English communication (C1).
• Experience with DeltaV Batch design and Recipe implementation.
• Experience with DCS (DeltaV), MES (PAS-X) and SCADA systems.

Responsibilities

• Serve as SME for control strategies for new equipment in GMP environment.
• Implement innovative technologies and control strategies to streamline manufacturing.
• Provide automation support for DCS, MES, SCADA and OEM systems.
• Lead continuous improvement projects and investigations into deviations.
• Coordinate technology transfers and qualification activities.
• Support Digital Transformation initiatives.

Skills

Automation controls

DeltaV Batch design

ISA S95/S88

GAMP 5

DCS/DCS (DeltaV)

MES (PAS-X)

Ignition MES

cGMP compliance

Troubleshooting

Continuous Improvement

Education

Bachelor's degree in Life Science

Tools

DeltaV

PAS-X

Ignition

Cytiva AktaRDY

AktaRDY XL

Sartorius Resolute BioSMB 80/350

Kneat eVal

Job description

Start Date: Ideally December 2026 or January 2027. People with longer notice will be considered

Job Description

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. You will be responsible for troubleshooting in compliance with cGMPs of various manufacturing systems within our biotechnology facility and actively contribute to continuous improvement projects. In addition, you will support DeltaV / MES Recipe and Technology Transfers and alignment from Process Development to the local site and then to the company's late-stage Facility in Ireland.

Bring energy, knowledge, innovation to carry out the following:

• 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
• 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.
• Participate and actively support Digital Transformation initiatives
• Limited off shift work may be required to meet project, operations, and qualification needs.

What skills you will need:

• 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/test, including 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.
• Min 3 years of experience in Automation or Engineering function for the life science
• 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, ModBus protocols) is preferred.
• Basic/working knowledge of an MES system (PAS-X, Syncade, Ignition MES) is advantageous.
• Commissioning and qualification, test protocol development and execution in Kneat eVal.