Role Overview
The Senior Process Engineer plays a central role in advancing sterile drug product manufacturing through scientific innovation and engineering rigor. This position leads the development and refinement of pharmaceutical processes, ensuring alignment with quality, safety, and regulatory standards. The engineer supports the transition of products from laboratory-scale development to full-scale production, with a focus on parenteral formulations and complex processing techniques.
Key Responsibilities
- Investigate chemical and physical interactions between excipients and active pharmaceutical ingredients to support stable formulation design
- Assess the impact of environmental and chemical variables on product stability and performance
- Design and prepare experimental formulations using various solvents and excipients for lab-scale testing
- Develop lyophilization cycles and other advanced processes including liposome preparation, tangential flow filtration (TFF), and handling of viscous formulations
- Lead scale-up activities and manage technology transfer from R&D to manufacturing operations
- Identify and procure materials, equipment, and tooling necessary for process development and production
- Generate and review technical documentation such as batch records, study protocols, SOPs, and process characterization reports to ensure compliance with cGMP and FDA requirements
- Conduct risk assessments and process design reviews to support safe, efficient, and compliant operations
- Define analytical testing strategies for critical quality attributes and coordinate with quality control teams
- Evaluate test data to assess process efficiency, detect equipment issues, and support troubleshooting
- Monitor in-process and release testing outcomes to control manufacturing parameters that influence product quality
- Maintain and troubleshoot laboratory instrumentation as needed
- Study how processing methods and packaging choices affect product composition and shelf life
- Innovate and refine formulations, equipment, and analytical approaches to enhance product quality
- Prepare technical reports, specifications, and standards for processes and facilities
- Ensure all work is conducted in accordance with safety protocols and regulatory guidelines
- Collaborate with scientists and engineers to interpret research findings and develop test methodologies
- Support compliance with FDA, OSHA, EPA, and other applicable regulations
- Lead validation efforts for equipment and manufacturing processes
- Investigate quality deviations, out-of-specification results, and batch record issues
- Drive continuous improvement initiatives to enhance process performance and laboratory safety
- Supervise, coach, and develop team members across functional areas
Qualifications
Applicants must hold a bachelor’s degree or higher in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science, along with a minimum of three years of experience in pharmaceutical research or manufacturing. Prior work in sterile processing environments is highly desirable. Familiarity with lyophilization and terminal sterilization methods is an added advantage.
Technical Requirements
Proficiency in cGMP and FDA regulatory standards is essential. Experience with Microsoft Office and Visio is required to support documentation and process mapping.
Work Environment
This is an on-site position requiring hands-on involvement in laboratory and manufacturing settings. The role demands strict adherence to safety and compliance protocols in a regulated environment.
