Role Name: MES Engineer/Validation Engineer

Location: Bothell, Washington (Onsite)

Duration: Contract

Note- Only W2 Candidates

Job Description

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.

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.

Thanks & Regards

4365 Route 1 South, Suite 105

Princeton, NJ 08540

Bhavesh Sharma

609-766-0092

[email protected]