About the Role
Our client, a rapidly expanding biopharmaceutical company at the forefront of innovative drug development, is looking for a dedicated Chemical Process Engineer to join their team on a fully remote basis. This role is integral to the scale-up and optimization of manufacturing processes for novel therapeutic agents. You will leverage your expertise in chemical engineering principles to design, develop, and troubleshoot processes that ensure the consistent production of high-quality pharmaceutical products. The position requires a deep understanding of cGMP (current Good Manufacturing Practices) and regulatory requirements within the pharmaceutical industry. As a remote team member, you will collaborate closely with research scientists, analytical chemists, and manufacturing personnel through advanced digital platforms. This is an exceptional opportunity for an experienced engineer to contribute to life-saving advancements from a convenient, remote location. We seek a detail-oriented individual with a strong scientific background and a passion for pharmaceutical innovation.
Key Responsibilities
- Design, develop, and optimize chemical synthesis and purification processes for pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
- Perform process simulations and modeling to assess feasibility, identify bottlenecks, and improve efficiency.
- Develop and execute process validation protocols in accordance with cGMP guidelines.
- Troubleshoot manufacturing issues and implement corrective and preventive actions (CAPAs).
- Author and review technical reports, batch records, and regulatory submission documents.
- Collaborate with cross-functional teams to ensure seamless transfer of processes from R&D to manufacturing.
- Stay current with regulatory guidelines (FDA, EMA) and industry best practices.
- Evaluate and recommend new process technologies and equipment.
- Manage projects related to process improvement and technology transfer.
- Ensure robust process safety assessments and implementation of safety measures.
Requirements
- Master's or Ph.D. in Chemical Engineering or a closely related field.
- Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of cGMP regulations and pharmaceutical manufacturing requirements.
- Proficiency in process modeling and simulation software relevant to chemical and biochemical processes.
- Experience with technology transfer and process validation.
- Strong analytical and problem-solving skills with a meticulous attention to detail.
- Excellent written and verbal communication skills, essential for remote collaboration and technical documentation.
- Proven ability to work independently and manage time effectively in a remote environment.
- Familiarity with sterile manufacturing processes is a plus.
- Experience with quality risk management (QRM) principles.
Benefits
- Our client offers a highly competitive salary and benefits package.
- As this is a fully remote position, you will enjoy the flexibility of working from anywhere, eliminating commute time and costs.
- Comprehensive health, dental, and vision insurance are provided.
- A generous retirement savings plan is available.
- Opportunities for professional growth through online courses, workshops, and virtual conferences are encouraged.
- Our client is committed to fostering a supportive and innovative remote work culture, enabling you to contribute significantly to impactful pharmaceutical advancements from Pretoria, Gauteng, ZA , or any other suitable location.
- Our client values employee well-being and career development.