Our client, a leading pharmaceutical company, is hiring a MES Engineer on a contract basis.
Work Location:
Bothell, WA – 100% On site
Knowledge/Skills/Education:
- Bachelors degree or equivalent experience.
- 5 years in computer or science-based field
- 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.
- 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.
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.