About the Role
Our client, a rapidly expanding pharmaceutical innovator, is seeking a talented and experienced Pharmaceutical Process Development Engineer to join their team in a fully remote capacity. This role is integral to optimizing and scaling up pharmaceutical manufacturing processes, ensuring efficiency, robustness, and cost-effectiveness. You will be responsible for designing, executing, and analyzing experiments to improve existing processes and develop new manufacturing methodologies for APIs and drug products. This fully remote position requires strong engineering principles, a deep understanding of chemical engineering fundamentals, and excellent problem-solving skills, all applied within a virtual collaborative environment. Your expertise will directly impact the company's ability to bring life-changing medications to market efficiently.
Key Responsibilities
- Develop, optimize, and scale-up pharmaceutical manufacturing processes (e.g., chemical synthesis, purification, formulation, sterile filling).
- Design and execute Design of Experiments (DoE) to understand process parameters and identify critical process controls (CPPs).
- Utilize process modeling and simulation tools to predict and optimize process performance.
- Troubleshoot process-related issues, identify root causes, and implement effective corrective actions.
- Develop process validation strategies and author validation protocols and reports.
- Collaborate with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Engineering in a remote setting.
- Conduct process hazard analyses (PHAs) and ensure safe operating procedures are developed and followed.
- Evaluate and recommend new technologies and equipment for process improvement.
- Stay current with industry trends, new technologies, and regulatory requirements in pharmaceutical manufacturing.
- Prepare technical reports, presentations, and documentation for internal stakeholders and regulatory submissions.
Requirements
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
- Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
- Strong understanding of chemical engineering principles, unit operations, and thermodynamics.
- Proven experience with process optimization, validation, and troubleshooting.
- Familiarity with cGMP regulations and pharmaceutical manufacturing guidelines.
- Proficiency in process modeling software (e.g., Aspen Plus, gPROMS) is highly desirable.
- Excellent analytical, problem-solving, and experimental design skills.
- Strong written and verbal communication skills, with the ability to collaborate effectively remotely.
- Experience with specific areas such as crystallization, filtration, drying, or sterile processing is a plus.
- Ability to manage projects independently and drive results in a remote environment.
Benefits
- Highly competitive salary, reflecting the demands of a senior remote engineering role.
- Comprehensive benefits package including health, dental, and vision insurance.
- Home office stipend and equipment provision to ensure an optimal remote workspace.
- Opportunities for significant career advancement and leadership in process development.
- Work on innovative pharmaceutical projects with a global impact.
- Flexible work schedule to accommodate personal and professional needs.
- Be part of a forward-thinking company dedicated to improving global health.