Job Description

Key Responsibilities

• Author and configure MES recipes (preferably PharmaSuite) to support manufacturing and tech transfer projects.
• Troubleshoot MES execution issues and integration with business systems on the plant floor.
• Ensure compliance with corporate standards, regulatory requirements, and validated design principles.
• Develop, review, and execute qualification and test plans in accordance with validation requirements.
• Create and maintain recipe requirement specifications, design documentation, and test scripts.
• Collaborate with process owners, global MES teams, and site engineering teams to ensure effective implementation.
• Translate production process requirements into robust MES configurations.
• Lead or support project-specific documentation efforts including implementation and validation plans.
• Contribute to standardization efforts for global recipe templates and site-specific workflows.
• Provide technical support and consultation for ongoing process improvement initiatives.
• Participate in a monthly on-call support rotation (1 week per month, after-hours support required).

Qualifications

• Bachelor’s or Master’s degree in Chemical, Electrical, Mechanical Engineering, Computer Science, or a related field.
• 5–7 years of experience in MES systems, preferably with PharmaSuite MES .
• Solid understanding of batch record structures, workflow design, and exception handling.
• Experience in a GMP-regulated manufacturing environment (pharmaceutical or biotech preferred).
• Strong communication and interpersonal skills; able to interface across functional teams.
• Self-starter with excellent problem-solving and multitasking abilities.
• Proficient in writing test cases, validation scripts, and project documentation.
• Familiarity with tech transfer processes and their impact on MES design and configuration.
• Experience working with global teams on template and standards development is a plus.

Additional Information

• Location: 100% On-site
• Schedule: Full-time; Monday–Friday with some on-call responsibilities
• Contract Type: Long-term contract with potential for extension

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