MES Recipe Engineer and Validation Specialist (Hybrid, Bothell, WA)

MES Recipe Engineer and Validation Specialist (Hybrid, Bothell, WA)

We are seeking an MES Recipe Engineer and Validation Specialist for a global Pharmaceutical client. The focus of the role is to 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.

This is a 40-hour per week, 6-month contract, 50% onsite role at client's office, in Bothell, WA.

Work Schedule-Standard Hours; M-F

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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

Requirements :

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.

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.

Experience with BarTender label development.

Experience with MES-ERP integrations.

Experience with new process and product deployments within a MES.

Bachelor's degree or equivalent experience.

Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the MES Recipe Engineer and Validation Specialist (Hybrid, Bothell, WA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation : $95 / hr - $101.04 / hr

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