Process Engineer

Process Engineering is responsible for supporting conceptual and detailed design, support in process scale-up, product development, process validation, and implementation of operational improvements that resolve manufacturing process investigations, where required.

Engineer’s Core Responsibilities:

·                Independently design experiments and evaluate data in support of improvements and investigations.

• Support failure investigations and implementation of solutions (CAPAs) that solve manufacturing and product problems, follow up on CAPAs to determine effectiveness and suitability and prepare/review written reports in a timely fashion.
• Draft technical reports in support of process changes, optimizations, and regulatory filings.
• Provide technical guidance and leadership to lesser experienced team members.
• Ensure maintenance/ required control of records of qualification and validation, Change Controls, Risk Assessments and CAPAs for future compliance audits

Requirements:

·                Demonstrated experience in:

o        Chiller Design

•  
  • P&IDs
  • Electrical
  • Piping
  • Instrumentation
  • Solvent Process
  • APIs
• Strong understanding of biological process validation activities including drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluations.
• Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas.
• Ability to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
• Familiar with regulatory audit process and capable of gathering supporting documents
• Proficient in computer skills and MS Office applications