Manufacturing Systems Engineer

5 days ago

Pune, Maharashtra, India beBeePharmaceutical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Title:

Rockwell FTPS MES Modeler

Location:

Mumbai / Pune

Experience Required: 6 to 12 years

Responsibilities:
  • Recipe Development & Configuration: We are seeking a skilled professional to develop and configure recipes in our Rockwell FTPS MES environment.
  • Gathering requirements for PI designing of a product: You will gather and analyze requirements for new product recipes, liaising with operations, validation, and subject matter experts.
  • Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements: This role requires strong communication skills to collaborate with cross-functional teams.
  • Design, author, and configure Electronic Batch Records (EBRs) using Rockwell FactoryTalk Pharma Suite (FTPS): The successful candidate will have experience with EBRs and be able to design, author, and configure them effectively.
  • Gather and analyse requirements for new product recipes by liaising with operations, validation, and subject matter experts: This includes analyzing site requirements and converting them into batch records.
  • Enable review-by-exception through robust recipe/workflow implementation: A key responsibility is to implement robust recipes and workflows that enable review-by-exception.
  • Troubleshoot and defects resolution during validation of PI's: Strong problem-solving skills are required to troubleshoot and resolve defects during validation.
  • Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch Records: A deep understanding of pharmaceutical, biotech, manufacturing, and shop floor order processes is essential for this role.
  • MES Implementation & Integration:
    • Implement MES solutions and integrate them with ERP systems and control equipment: Experience with MES implementation and integration is necessary.
    • Validate recipes with internal and site teams, ensuring alignment across departments: Strong communication skills are required to validate recipes and ensure alignment across departments.
  • Documentation & Compliance:
    • Document MES configurations and validate EBRs: The successful candidate will have experience with documentation and compliance.
    • Ensure compliance with FDA and GMP guidelines: Strong knowledge of FDA and GMP guidelines is required.
    • Maintain documentation in line with Life Sciences validation processes: Excellent organizational skills are required to maintain documentation in accordance with life sciences validation processes.
  • Project Coordination & Communication:
    • Provide regular status updates to the Project Manager on progress, issues, and risks: Strong communication skills are required to provide regular status updates.
    • Work with product vendors on issues during upgrades: Experience with vendor management is necessary.
  • IT Skills:
    • Knowledge on SQL development, VB6, C#, .Net: Proficiency in SQL development, VB6, C#, and .Net is required.

Qualifications:

  • Bachelor's degree or equivalent (minimum 3 years of work experience).
  • Minimum 5 year of hands-on experience with Rockwell FTPS MES in a highly automated Life Sciences environment.
  • Strong understanding of SDLC and support methodologies.
  • Excellent communication and collaboration skills.
  • Ability to work in a team-oriented, fast-paced environment.

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