Process Engineer

Business: Pharma Solution

Department: Technical Services

Location: Lexington

Job Overview

The Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines.

Reporting Structure

Directly reports to Technical Services Manager

Key Responsibilities

• Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing.
• Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
• Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
• Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
• Take initiative to develop and improve procedures and setups through the change control process.
• Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.
• Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
• Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
• Maintains awareness of current developments in the functional discipline
• Reviews current and new processes; applies state-of-the art technology to our processes
• Coordinate line activities with other functions such as maintenance and downstream manufacturing events.
• Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
• Maintains documentation on all projects and submit written reports in a timely fashion.
• Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory and Manufacturing operations.
• Train Manufacturing staff on new processes and/or equipment technologies, as needed
• Interacts with external vendors.
• Independently plan and organize non-routine tasks. Initiates and maintains work schedule. Follow-through on priorities of work assignments.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Education Requirements

• Bachelor degree in Mechanical, Biological, or Chemical Engineering

Experience

• 5+ years of experience working within pharmaceutical manufacturing/development environment, process development and scale-up, contract manufacturing strongly preferred
• Experience working within aseptic or lyophilization manufacturing

Competencies

• Knowledge and understanding of cGMPs validation requirements and techniques.
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
• Knowledge and understanding of the regulatory approval process for US, EU, and JP
• In-depth knowledge of pharmaceutical parenteral manufacturing principles and packaging equipment
• Working knowledge of lyophilized and aseptic product validation is desirable
• Ability work within and lead a cross-functional team which may include operations, quality assurance, validation, and laboratory personnel
• Good oral and written communication skills
• Able to handle multiple complex tasks and set priorities with multiple internal customers
• Proficiency using Microsoft Office applications (Word, Excel, PowerPoint)