Full Job Description
We are looking for GxP System Engineers that are passionate for system integrations, GxP software management systems, and industrial automation applications to scale and digitize our cell therapy manufacturing operations to meet our clients' and patients' need.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Highly motivated, collaborative, dynamic, and works effectively under minimal supervision.
Serve as the SME to design, configure, test, and deploy electronic GxP automated software systems.
Administer assigned GxP software systems regularly performing user asset management, periodic monitoring and audit trail review, system enhancements and upgrades, and process improvements.
Provide support to internal personnel and external partners to resolve issues, identify gaps, and recommend changes to meet project goals, deliverables, and compliance requirements.
Excellent technical writing and proven success in authoring business and user requirements, functional design specifications, user acceptance testing, validation test scripts (IQ/OQ/PQ), and training material for end users.
Provides end-user support and troubleshooting for deployed systems and tools.
Experienced in communicating and negotiating technical software and hardware architecture, design features, and operations.
Perform and author data integrity, automation, and GxP risk assessments to ensure effective requirements are captured and controls are installed to meet global regulatory requirements for GxP systems.
Ensure automated systems are deployed with robust access controls, audit trail reporting, and data integrity checks to meet global regulatory compliance requirements.
Lead system integration projects, develop and design IIOT applications, and configure and deploy electronic systems to drive digital transformation initiatives and ensure released applications meet regulatory compliance requirements.
Configure GxP automated systems to improve existing business processes and to generate operational data for data insights, reporting, and visualizations.
Vendor Management Excellence:
Experienced success in working with multiple vendors across different projects and timeliness.
Collaborate with vendors (as part of a team) to define business and user requirements and ensure the system design meets internal requirements.
Experience working within compliant and regulated environments.
Data integrity and computer system validation knowledge (FDA 21 CFR Part 11, EudraLex Annex 11).
Systems Engineer I: 0-2 years experience (new grads encouraged to apply)
Systems Engineer II: 2-5 years experience.
Systems Engineer II: 5 years+ experience.
Degree in Engineering, Information Technology, Information Systems, or Computer Science.
Knowledge of cell culture or cell therapy manufacturing technical support.
Knowledge of cell therapeutics product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, and commercial GMP manufacturing.
Knowledge and application of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation.
Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
Experience in managing software implementations of the following applications is highly valued:
Laboratory Information Management Systems (LIMS)
Electronic Quality Management Systems (eQMS)
Manufacturing Execution Systems (MES)
Regulatory Asset Management Systems (RAM)
Building Automation System (BAS)
Enterprise Resource Planning (ERP)
Analytical and Manufacturing software systems