Chief Technical Advisor

3 days ago

Ellore, Andhra Pradesh, India beBeeSME Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Highly skilled professionals are sought after to assume a key role in the implementation of Manufacturing Execution Systems (MES) and related systems at our production sites. The ideal candidate should possess extensive experience in the pharmaceutical industry, particularly in technical and functional roles involving MES & L2 systems.

Key Responsibilities:
  • Ensure site-specific manufacturing processes are accurately captured and reflected in the global MES solution.
  • Lead site-level validation activities and take on technical owner responsibility for all GxP documentation related to the MES & L2 system.
  • Develop deep knowledge of system functionality, configuration, and compliance requirements.
  • Act as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-deployment.

The successful candidate will ensure adherence to global regulations such as FDA 21 CFR Part 11, EU GMP, and GAMP5.

Requirements:
  • 6-8 years of experience in the pharmaceutical industry.
  • Strong understanding of pharma shop floor operations and regulatory requirements.
  • Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.
  • Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
  • Experience in resolving front-end MES issues and supporting end-users post-deployment.
Preferred Qualifications:
  • Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Masters degree with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields.

The ideal candidate will possess strong communication and interpersonal skills, be proactive in problem-solving and risk management, and have a high attention to detail and compliance mindset.

Additional Skills:
  • Knowledge of data analytics tools.
  • Edge Cloud deployment experience with IoT and IIoT.
  • L2 integration with MES.
  • MES integration with SAP.
  • Understanding of network and databases.

A detailed resume and cover letter outlining relevant experience and qualifications should be included with your application.

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