MES Validation Specialist

Job Description

Job Title: MES Recipe Engineer and Validation Specialist

Location: Bothell, WA

Junior Role (2-5 y) - need 3 consultants total

TOP SKILLS:

• 3 years experience in Pharmaceuticals/Life Sciences digital manufacturing (GMP/G×P experience)
• Syncade Manufacturing Execution System (MES) including Recipe Authoring and System Administration
• Microsoft Server/Microsoft SQL/BA

Job Description:

• Improve and sustain operations at Biologics, Oral Solid Dosage, and Clinical manufacturing plants by supporting ongoing and future project work.
• Working directly with manufacturing operations, manufacturing technology, site IT, Quality, and other groups to understand business requirements for corrective actions and continuous improvement initiatives.
• Create business and technical process maps to reflect the current state and proposed changes.
• 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 system changes.

PURPOSE AND SCOPE OF POSITION (Position Summary): 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.

QUALIFICATION REQUIREMENTS (Knowledge, Skills, and Abilities): Education:

• Bachelor's degree or equivalent experience.

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.

Preferred Qualifications:

• Experience with SQL and XML coding in an 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 the 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.
  
  Please apply on the Lifelancer platform at the below link for screening steps & quicker response.
  
  https://lifelancer.com/jobs/view/18f2e159a4c228085ca6932454ac6b82