MES EBR Expert

Company Description

PDDN is a provider of end-to-end software solutions and IT consulting Services and software development Company. is headquartered in Fremont, California with clients across the Silicon Valley and other Information technology Hubs in different states. With integrated solutions, software development, technical services, training and staffing support, we help customers achieve their technology goals allowing them to focus on their business.

Job Description

Role: MES/EBR Expert
Location: Remote
Job Type: Contract (C2C/W2)
Interview: Phone/Skype

JOB DESCRIPTION:
Experienced engineer to work with major Consumer Products client in support of developing major MES and EBR systems.
You will play a critical role in the design, implementation, and
maintenance of MES and EBR systems. You will ensure compliance with industry
standards and regulations while optimizing production processes. The job location can be anywhere in the U.S. Occasional international travel may be required.
•Leading or assisting in the UAT process, including test plan creation, execution, and issue resolution
•Supporting the validation process for MES and EBR systems, ensuring they meet business and regulatory standards
•Training end-users on MES and EBR systems, ensuring they are well-versed in operational and compliance requirements.

•In-depth understanding of the processes in manufacturing plants, especially in regulated industries like pharmaceuticals, chemical or biotech (5)
•Knowledge of GMP regulations, including FDA 21 CFR Part 11, Part 210, and Part 211. Understanding of how EBR ensures regulatory compliance by eliminating paper-based records (5)
•At least 7-10 years of experience in managing electronic batch records in the Life Sciences industry and ensuring that all batch data is accurately captured, reviewed, and stored in EBR systems (5)
•Gathering and translating business requirements into functional specifications. Ability to work with stakeholders (production teams, quality assurance, regulatory bodies) to define system requirements (5)
•Ability to map out current processes and identify gaps or inefficiencies in the system or processes (5)
•Expertise in the specific MES platforms used in the organization (e.g., Ignition/Sepasoft, Siemens Opcenter, Rockwell FactoryTalk) (5)
•Deep understanding of how EBR systems work, including document control, Batch and Recipe Management, record-keeping, approval workflows, and integration with the MES (5)
•Familiarity with system integration (e.g., ERP, LIMS, PLC systems, SCADA, and other enterprise systems) and understanding integration tools like MQ, SOAP, RESTful API (5)
•Bachelor's Degree in an Engineering, Computer Science, or equivalent discipline(5)

Additional Information

All your information will be kept confidential according to EEO guidelines.