Description

You will support the MES Syncade system and optimize manufacturing workflows through targeted enhancements and validation.

This role is on-site.

Responsibilities

• Support the MES Syncade system and optimize manufacturing workflows.
• Review Functional Requirement Specifications (FRS) and test scripts for alignment with manufacturing needs.
• Design experiments, evaluate data, and support failure investigations including CAPA implementation.
• 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.

Required Skills

• 4-6 years of experience in project phases: requirements documentation, detailed design, implementation, system integration, testing, and on-site startup.
• Expertise in Process Design, Quality Control, and Continuous Process Verification.
• 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.
• Proficiency in Microsoft Project.
• Ability to communicate technical requirements and rationale effectively to various organizational levels.

Preferred Skills

• Experience providing technical guidance and mentorship to less experienced team members.

Key Skills

Education

Any Graduate