Description

You will serve as the primary support for the MES Syncade system to ensure seamless integration with manufacturing processes.

Responsibilities

• Support the MES Syncade system and optimize manufacturing workflows through MES enhancements.
• Review Functional Requirement Specifications (FRS) and test scripts for manufacturing alignment.
• Design experiments, evaluate data, and support failure investigations including CAPA implementation and effectiveness tracking.
• Draft technical reports for process changes, optimizations, and regulatory filings.
• Maintain records for qualification, validation, Change Controls, Risk Assessments, and CAPAs to ensure audit compliance.
• Provide technical guidance and mentorship to less experienced team members.

Required Skills

• 4-6 years of role-relevant experience.
• Expertise in project phases: requirements documentation, detailed design, implementation, system integration, testing, and on-site startup.
• Knowledge of process manufacturing, field instrumentation, and control system installation.
• Understanding of biological process validation, including drug substance manufacturing, drug product filling, filtration, mixing, sterilization, and lyophilization.
• Experience with process simulations (media fills) and validation risk assessments.
• Strong understanding of Process Design, Quality Control, and Continuous Process Verification.
• Proficiency in Microsoft Project.
• Ability to communicate technical requirements and rationale effectively to various organizational levels.

Key Skills

Education

Any Graduate