Description

You will support conceptual and detailed design, process scale-up, and product development while implementing operational improvements to resolve manufacturing investigations.

Responsibilities

• Design experiments independently and evaluate data to drive process improvements and investigations.
• Lead failure investigations and implement CAPAs to resolve manufacturing and product issues.
• 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.
• Experience with Chiller Design, P&IDs, Electrical, Piping, and Instrumentation.
• Expertise in Solvent Process and APIs.
• 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, such as temperatures, pressures, and valve sequencing, to troubleshoot equipment.
• Familiarity with regulatory audit processes and document gathering.
• Proficiency in MS Office applications.
• Ability to work in CNC spaces, ISO classified rooms, and grey space.

Key Skills

Education

Any Gradute