Manufacturing Execution Systems Engineer

1 day ago

Bothell, United States Novozen Healthcare LLC Full time

Job Title: MES Engineer


Eligibility: U.S. Citizens and Green Card Holders only

Experience Required: 3-4 years

Job Overview:

We are seeking a skilled MES Engineer with 3-4 years of experience in the pharmaceutical or biotech industry to join our team. The MES Engineer will be responsible for the implementation, configuration, and ongoing support of Manufacturing Execution Systems (MES) to ensure seamless integration with manufacturing processes in a GMP-regulated environment. This role requires strong technical skills, hands-on experience with MES platforms, and the ability to collaborate with cross-functional teams to optimize production workflows.

Key Responsibilities:

  • Implement and Maintain MES Systems: Support the configuration, deployment, and maintenance of MES platforms to streamline manufacturing operations, ensuring compliance with GMP regulations.
  • Process Integration: Collaborate with process engineers and IT teams to integrate MES systems with ERP, SCADA, and other manufacturing systems.
  • Data Collection and Analysis: Leverage MES to capture critical production data, generating reports and ensuring accurate traceability across the production lifecycle.
  • System Validation: Assist in developing validation protocols, performing system testing (IQ, OQ, PQ), and ensuring systems are compliant with FDA regulations.
  • Troubleshooting and Support: Provide day-to-day technical support, addressing issues with MES software, hardware, and network infrastructure in a timely manner to minimize downtime.
  • Continuous Improvement: Identify opportunities to improve the efficiency of MES and related systems to enhance manufacturing productivity.
  • User Training: Provide training and technical guidance to manufacturing personnel on MES functionalities and best practices.
  • Documentation: Create and maintain detailed documentation, including system configuration, validation reports, user manuals, and SOPs.

Qualifications:

  • Experience: 3-4 years of experience in MES engineering, preferably in a pharmaceutical or biotech environment.
  • Education: Bachelor’s degree in Engineering, Information Technology, or a related field.
  • Technical Skills:
  • Hands-on experience with MES platforms such as Werum PAS-X, Emerson Syncade, or Rockwell Automation PharmaSuite.
  • Knowledge of GMP, FDA regulations, and 21 CFR Part 11.
  • Proficient in database management, SQL queries, and system integration.
  • Familiarity with manufacturing processes in a pharmaceutical setting, including batch processing and electronic batch records (EBR).
  • Problem-Solving: Strong troubleshooting and analytical skills to resolve system-related issues effectively.
  • Communication Skills: Excellent verbal and written communication skills, with the ability to collaborate with cross-functional teams.

Eligibility Requirements:

  • Must be a U.S. Citizen or Green Card holder.
  • Strictly no C2C.

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