Description

You will own process scale-up, product development, and operational improvements to resolve manufacturing investigations.

This role is on-site.

Responsibilities

• Design and evaluate experiments to drive process improvements and investigate manufacturing issues.
• Lead failure investigations and implement CAPAs to resolve product and manufacturing defects.
• Draft technical reports for process optimizations, changes, and regulatory filings.
• Maintain records for qualification, validation, Change Controls, Risk Assessments, and CAPAs.
• Provide technical guidance and leadership to junior team members.

Required Skills

• 5+ years of experience in process engineering.
• Expertise in Solvent Process and APIs.
• Experience with Chiller Design, P&IDs, Electrical, and Piping.
• Strong understanding of biological process validation, including drug substance manufacturing and drug product filling.
• Knowledge of process simulations (media fills), filtration, mixing, sterilization, and lyophilization.
• Ability to complete validation risk assessments and evaluations.
• Capability to use process data (temperatures, pressures, valve sequencing) to troubleshoot equipment.
• Familiarity with regulatory audit processes and document gathering.
• Proficiency in MS Office applications.

Preferred Skills

• Ability to work in CNC spaces, ISO classified rooms, and grey space.

Key Skills

Education

Any Gradute