Process Engineer

Job Description:

Job Title: Process Engineer

Job Summary:

The Process Engineer in the pharmaceutical industry is responsible for developing, optimizing, and scaling up manufacturing processes to ensure the efficient production of high-quality pharmaceutical products. This role involves working closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to design processes that are robust, cost-effective, and compliant with regulatory standards.

Key Responsibilities:

• Process Design and Development: Design and develop scalable, reproducible, and efficient manufacturing processes for pharmaceutical products, including small molecules, biologics, and other complex formulations.
• Process Optimization: Continuously evaluate and improve existing manufacturing processes to enhance efficiency, reduce costs, and improve product quality, while maintaining compliance with GMP and other regulatory requirements.
• Scale-Up: Lead the scale-up of processes from laboratory to pilot plant to full-scale production, ensuring consistency and quality across different scales of manufacturing.
• Technology Transfer: Collaborate with R&D and manufacturing teams to ensure smooth technology transfer of processes from development to production, including the preparation of process transfer documentation and training of production staff.
• Process Validation: Develop and execute process validation protocols (IQ/OQ/PQ), ensuring that processes produce consistent and reliable results in line with regulatory guidelines.
• Equipment Selection and Qualification: Assist in the selection, installation, and qualification of manufacturing equipment, ensuring it meets the requirements of the designed processes.
• Troubleshooting and Problem-Solving: Identify and resolve process-related issues, implementing corrective and preventive actions (CAPAs) to address deviations and non-conformities.
• Compliance and Documentation: Ensure all processes and procedures comply with regulatory standards (e.g., FDA, EMA) and prepare and maintain accurate process documentation, including batch records, SOPs, and validation reports.
• Risk Assessment: Conduct risk assessments and Failure Modes and Effects Analyses (FMEA) to identify potential process risks and implement mitigation strategies.
• Continuous Improvement: Stay informed of industry trends, new technologies, and best practices in process engineering, and lead continuous improvement initiatives to enhance manufacturing capabilities.
• Safety: Ensure that all processes comply with safety standards and environmental regulations, and contribute to the development of safety procedures and training programs.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Experience: 3-7 years of experience in process engineering within the pharmaceutical or biotechnology industry.
• Technical Skills: Strong knowledge of process development, scale-up, and validation, as well as experience with process simulation software and statistical analysis tools (e.g., Minitab, JMP).
• Regulatory Knowledge: Familiarity with GMP, FDA, EMA, and other relevant regulatory guidelines and requirements.
• Soft Skills: Excellent problem-solving skills, strong attention to detail, effective communication skills, and the ability to work both independently and as part of a team.