IT Quality Control Systems Engineer

Job Description

Position Brand Description:

The main function of the Quality Control Systems Engineer is to design, develop, implement, enhance, and maintain the various software applications that help optimize lab and /or manufacturing processes, and reduce errors and increase efficiency, by integrating production operations with business systems.

Key Objectives/Deliverables:

Conduct testing, troubleshooting, and ongoing maintenance of assigned applications to ensure system reliability and accuracy of data.

Stay up to date with emerging trends in technologies that support the integration of GMP systems.

Ensure documented processes and procedures are in place for all activities to meet quality and compliance standards.

Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing operations.

Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices.

Train and assist business users in proper use of applications and computerized systems.

Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.

Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices.

Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

Manage Relationships with Key Stakeholders and Customers:

Serve as a liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IDS, QC, QA, Manufacturing, AEG, vendors, and other relevant functional areas.

Build enterprise and cross-site connections to ensure integration and results.

Basic Requirements:

Bachelor’s degree in software engineering, Computer Science, Computer Engineering, or a related field.

Minimum of 4+ years of experience working with lab and/or manufacturing systems. E.g: MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X, SmartLab, Empower.

Must have strong analytical and problem-solving skills.

Must have a strong understanding of GMP processes related to manufacturing and lab applications.

Must have excellent communication skills.

Experience with 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies.

Experience with GMP system interface technologies (ie EDGE; xml, iot integration, PDF parsing etc..).

Experience with basic programming languages required to export/transform data - E.g.: programming languages such as C++, Java, Python, and SQL.

Must understand cybersecurity concepts and best practices related to data and operating system security.

Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.

Analytical and problem-solving skills to identify and resolve complex technical issues.

Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.

Experience with Computer System Validations is a plus.

This role is exempt and the anticipated compensation for this role is $118,500-$158,000.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.

Full-time

Hybrid remote