Job Description:
We are seeking a QC Lab Support Engineer to join our team. The ideal candidate will have strong experience in SoftMax implementation, GMP environments, and Lab Execution System (LES) configuration and support and a proven ability to optimize lab and manufacturing processes, maintain validated systems, and integrate LES with enterprise and shop-floor systems.
Responsibilities:
· System design and configuration of LES solutions, including workflow builds and equipment integration based on requirements.
· Process optimization across manufacturing and laboratory workflows to reduce cycle times and enhance data integrity.
· Frontline technical support for LES platforms to ensure availability and timely issue resolution.
· Integration between LES and ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA) for reliable data flow.
· Validation and compliance activities, including execution of IQ/OQ/PQ and maintenance of validated, GxP-compliant systems.
· Stakeholder collaboration with Manufacturing Operations, Quality Assurance, and Process Science to gather requirements and report progress.
· User training and enablement with materials and sessions for effective LES adoption.
Required Skills & Qualifications:
· Bachelor’s degree in Engineering or related technical field, or equivalent experience.
· Hands-on configuration and support of an LES platform (e.g., LabVantage, Waters Empower, SoftMax).
· SoftMax implementation experience.
· Good Manufacturing Practices (GMP) knowledge and GxP familiarity, including CSV principles.
· Experience in manufacturing environments such as pharmaceutical, biologics, or animal health.
· Understanding of PLCs, SCADA, and integration with higher-level systems.
· SQL for data queries, troubleshooting, extraction, and reporting.
· Proficiency in Python, JavaScript, or similar scripting languages.
· AI literacy using approved GenAI tools for productivity, with validation and secure data handling.
Preferred Skills:
· LabVantage LES experience.
· Strong analytical troubleshooting and systematic problem-solving.
· Business process analysis and workflow design capability.
· Effective cross-functional communication with operators, scientists, and management.
· Familiarity with Microsoft Azure or Google Cloud Platform.
· Understanding of DevSecOps concepts, CI/CD, and source control (Git).
· Clear verbal and written communication.
Pay: $40.00 - $50.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
