QC Lab Engineer (Lab Execution Systems)

BCforward is seeking a QC Lab Support Engineer to work onsite in Fort Dodge, Iowa

QC Lab Support Engineer

Fort Dodge, Iowa- onsite

Contract to hire after 6 months

Any location: Indianapolis, IN; Clinton, IN; Fort Dodge, IA; Elwood, KS; Winslow, ME; Speke, must work primarily on site in one location and be willing to travel periodically

Your Responsibilities:

• System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of LES solutions. This includes building and modifying system workflows and configuring equipment integration based on defined requirements.
• Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. You will use LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level.
• System Management and Support: Provide frontline technical support for LES platforms. You will act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for our manufacturing and lab teams.
• Integration: Assist with the integration between LES and other critical systems, such as our ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data.
• Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for LES enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements.
• Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.
• User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the LES systems effectively in their day-to-day roles.

What You Need to Succeed (Minimum Qualifications):

• Educational Background: A bachelor’s degree in engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field or equivalent experience.
• Required Experience: Prior hands-on experience with the configuration, and support of an LES platform (e.g., LabVantage, Waters Empower, SoftMax etc.).
• Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.
• Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.
• Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate with higher-level manufacturing systems.
• Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation.
• Programming & Scripting: Proficiency in Python, JavaScript, or similar languages.
• AI Literacy: Proficiency in using approved GenAI tools to improve engineering productivity, including effective prompting, output validation, and secure handling of regulated data.

What Will Give You the Competitive Edge (Preferred Qualifications):

• Problem-Solving: Strong analytical and troubleshooting skills, with the ability to systematically diagnose and resolve technical issues.
• Process Analysis: A solid understanding of business process analysis and workflow design. Ability to read and interpret process maps and requirements documents.
• Cross-Functional Collaboration: Good communication and interpersonal skills, with a proven ability to work effectively in a team environment with operators, scientists, and management.
• Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP), is a plus.
• DevSecOps: Familiarity with the concepts of DevSecOps, including Continuous Integration/Continuous Delivery (CI/CD) and source control (Git), is desirable.
• Communication Skills: Good verbal and written communication skills, with the ability to collaborate effectively within a technical team.

Nice to have LabVantage LES

Must have SoftMax implementation

Must have GMP