Job Description
Specialists in Life Science Automation and IT Systems are sought after to provide manufacturing automation and IT systems engineering, project management and validation services.
The successful candidate must have at least 5 + years' experience supporting the automation aspects of manufacturing and packaging equipment in a GMP-regulated environment.
Key Responsibilities include providing automation guidance and expertise to multi-disciplinary project teams executing projects on Vial/Syringe Filling Lines, Packaging and Production environments.
Deliver automation solutions for new SKIDS in clean utilities, ensuring robust, compliant, and efficient operation.
Provide technical leadership and support to project teams throughout the project lifecycle, from design through commissioning.
Configure, program, and troubleshoot Siemens PLCs and HMIs for SKID-based systems.
Generate and review engineering documentation, including User Requirement Specifications, Functional Design Specifications, and System Architectures.
Contribute to project risk assessments and data integrity assessments and generation of validation documentation (Validation Plans, SAT & IOQ Protocols, Requirement Traceability Matrices).
Execute IOQ protocols and support validation activities on-site.
Required Skills and Qualifications
* Bachelor's degree in Electrical/Electronic Engineering, Computer Science, Chemical Engineering, Biotech Engineering, Physics & Instrumentation, or a related discipline.
* Minimum 5+ years' relevant experience in automation engineering, ideally within biopharmaceutical or clean utilities environments.
* Proven hands-on experience with Siemens PLC and HMI hardware/software.
* Experience with SKID-based automation systems in clean utilities is highly desirable.
* Strong background in control systems automation, including vendor management and technical oversight.
* Familiarity with control system network architectures, virtual server infrastructures, firewalls, and segmentation.
* Knowledge of GAMP software development lifecycle and validation practices.
Benefits