Job Title: MES Engineer
Location: Bothell, WA (Hybrid)
Duration: 12 Months
Job Description:
- The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES). This role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional departments
Knowledge, Skills, and Abilities:
- 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
Preferred Qualifications:
- Experience with SQL and XML coding in a MES construct. MS Windows Server and SQL server also a plus
- Experience with cell therapy or other biopharmaceutical manufacturing. Other highly regulated industries will be considered
- Flexibility to work within manufacturing schedules
- Experience with BarTender label development
- Experience with MES-ERP integrations
- Experience with new process and product deployments within a MES
Roles and Responsibilities:
- Collaborate with Manufacturing, Supply Chain, Quality, Facilities and Tech Transfer departments, capturing and documenting detailed requirements
- Perform application support duties for the manufacturing execution system (MES) as needed
- Develop standards and best practices for development and validation activities
- Lead cross-functional teams through design reviews and user acceptance testing during the development and validation process
- Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification
- Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed software solutions
- Develop MES solutions including recipe, configuration and/or system changes to meet business requirements
- Create and execute system test and/or operational qualification scripts to challenge the business and technical requirements
- Participate in facility operational meetings to ensure facility reporting needs are met
- Provide mentorship and training for new MES recipe developers
- Assure quality customer service to all customers
- Position also requires availability to be “on call” off-shift hours, based on a rotating schedule, to support manufacturing operations
Education:
- Bachelor’s degree or equivalent experience
Experience:
- 5+ years in computer or science-based field
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.