About the Role
Our client, a highly innovative pharmaceutical company committed to advancing healthcare solutions, is seeking a talented and experienced Remote Pharmaceutical Process Development Engineer. This crucial, fully remote position will focus on designing, optimizing, and scaling up manufacturing processes for novel pharmaceutical products. The ideal candidate will possess a deep understanding of chemical engineering principles, process development methodologies, and pharmaceutical manufacturing technologies. You will be instrumental in translating laboratory-scale discoveries into robust, efficient, and scalable manufacturing processes that meet stringent quality and regulatory standards. This is an exceptional opportunity to contribute your expertise to a leading pharmaceutical organization from a remote work setting, driving the development of critical therapies. We are looking for a self-motivated, analytical, and results-oriented engineer who can effectively manage projects and collaborate virtually with cross-functional teams. The role demands a strong grasp of process validation and technology transfer. Join a team that values innovation and excellence in pharmaceutical manufacturing.
Key Responsibilities
- Develop and optimize manufacturing processes for new pharmaceutical products, from laboratory scale to pilot scale and commercial scale.
- Design and execute process development studies to define critical process parameters (CPPs) and establish process control strategies.
- Perform process modeling, simulation, and risk assessments to identify potential issues and optimize process performance.
- Develop and validate analytical methods for in-process controls and raw material testing.
- Troubleshoot and resolve process-related issues encountered during development, scale-up, and technology transfer.
- Author process development reports, technology transfer documents, and contributions to regulatory filings.
- Collaborate closely with formulation scientists, analytical chemists, quality assurance, and manufacturing personnel in a virtual environment.
- Ensure all process development activities are conducted in compliance with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
- Stay current with emerging technologies and best practices in pharmaceutical process development and manufacturing.
- Manage project timelines, budgets, and resources effectively for assigned projects.
Requirements
- Master's or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical process development and scale-up.
- Strong understanding of chemical engineering principles, unit operations, and process design.
- Extensive experience with pharmaceutical manufacturing processes (e.g., granulation, drying, milling, tablet compression, sterile filling).
- Knowledge of GMP regulations and validation principles relevant to pharmaceutical manufacturing.
- Proficiency in process simulation software (e.g., Aspen Plus) and statistical analysis tools.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, essential for remote collaboration.
- Demonstrated ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
- Experience with technology transfer to manufacturing sites is highly desirable.
Benefits
- This fully remote position offers a competitive salary, comprehensive health, dental, and vision insurance, a retirement savings plan with company match, and ample paid time off.
- Our client provides excellent opportunities for professional development, skill enhancement, and career progression within the pharmaceutical industry.
- You will have the flexibility to work from anywhere while contributing to the development of life-changing medicines.
- Join an innovative company culture that fosters collaboration, creativity, and employee well-being, making a significant impact on global health from your home office.