Manufacturing Execution System Specialist

7 days ago

India beBeeMES Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description

Achieve significant impact within the life sciences and biotechnology sectors by leading change initiatives in Manufacturing Execution Systems (MES). This pivotal role demands expertise in MES systems, change control processes, and cross-functional collaboration.

Key responsibilities include coordinating non-standard change requests, developing and maintaining documentation, collaborating with IT, Quality, Manufacturing, and Engineering teams, and ensuring compliance with regulatory requirements.

  • Coordinate and manage non-standard change requests through work intake, including impact assessments, risk analysis, and stakeholder approvals.
  • Develop and maintain comprehensive documentation, such as process maps, solution designs, component designs, validation plans, test scripts, user acceptance testing, and standard operating procedures.
  • Collaborate with cross-functional teams to ensure successful implementation of MES changes.
  • Ensure adherence to regulatory requirements, including FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), and internal quality standards.
Requirements

This position requires a strong background in MES systems, change control processes, and GMP. Key qualifications include:

  • Bachelor's degree in Engineering, Computer Science, Information Systems, or related field.
  • 8+ years of experience in MES systems, such as Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter.
  • Strong understanding of change management principles and methodologies.
  • Experience in regulated manufacturing environments, including pharmaceuticals, biotechnology, and medical devices.
  • Familiarity with GxP, GMP, and validation practices.
  • Excellent communication, documentation, and project management skills.
  • Ability to work independently and collaboratively in a fast-paced environment.

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