- Engage with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer departments to capture and document detailed requirements.
- Provide application support for the manufacturing execution system (MES) when necessary.
- Establish standards and optimal practices for development and validation tasks.
- Guide cross-functional teams through design reviews and user acceptance testing in the development and validation phases.
- Plan, develop, review, and test solutions for recipe creation and modifications, ensuring effective communication.
- Implement new capabilities across Manufacturing systems by developing software solutions aligned with requirements and specifications.
- Design MES solutions, including recipe, configuration, and system modifications, to meet business needs.
- Develop and execute system test and operational qualification scripts to validate business and technical requirements.
- Attend facility operational meetings to address and fulfill facility reporting requirements.
- Provide guidance and training to new MES recipe developers.
- Deliver high-quality customer service to all clients.
- Available for on-call support during off-shift hours on a rotating schedule to assist manufacturing operations.
- 5+ years in computer or science-based field
- Bachelor's degree or equivalent experience
- Direct experience in Emerson Syncade MES System.
- Experience in another MES system will be considered.
- Experience with writing and executing validation protocols.
- Strong technical writing competency and GMP procedure writing.
- Strong interpersonal skills to work with teams in different functions and organizations.
- Proficiency in SQL and XML coding within a Manufacturing Execution System (MES) environment.
- Knowledge of MS Windows Server and SQL Server is advantageous.
- Experience in cell therapy, biopharmaceutical manufacturing, or similar highly regulated industries is preferred.
- Ability to accommodate manufacturing schedules with flexibility.
- Familiarity with BarTender label development.
- Background in implementing new processes and products within a Manufacturing Execution System (MES).
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MES Engineer - Seattle, United States - Enginuity Advantage
Description
Job Description
Job DescriptionMES Engineer Summary
The MES Recipe Engineer and Validation Specialist involves configuring and validating electronic batch records (EBRs) within the Emerson Syncade Manufacturing Execution System (MES). This role will assist in implementing new products and processes and updating EBRs in collaboration with various cross-functional departments within the MES environment.
Position Responsibilities:
Qualifications:
We are looking to hire for an upcoming contract, and look forward to learning more about your experience.