Job Overview:

We are seeking a skilled Process Engineer to develop, optimize, and validate production processes for specialized drug delivery systems. This role ensures compliance with regulatory standards and provides technical oversight for process scale-up and validation in a GMP-controlled environment.

Key Responsibilities:

• Develop and refine manufacturing processes for drug delivery products, collaborating with cross-functional teams.
• Prepare and execute experimental and validation protocols for chemical processing, coating, and finishing operations.
• Analyze process data using statistical tools (SPC, ANOVA, DOE) to drive process improvements.
• Generate technical documentation to support product development and commercialization.
• Utilize software tools for engineering analysis, project tracking, and reporting.
• Provide technical support to production teams, troubleshooting process deviations and identifying corrective actions.
• Lead problem-solving initiatives and implement changes through change control procedures.
• Mentor and train team members on best practices in process optimization and regulatory compliance.
• Ensure all work aligns with quality system requirements and regulatory standards (e.g., 21CFR211).

Additional Responsibilities:

• Collaborate with internal and external stakeholders to improve manufacturing processes and product quality.
• Conduct root cause analysis for deviations and implement preventive measures.
• Support operations teams during production of developmental and validation batches.
• Participate in continuous improvement initiatives and contribute to innovation in process technology.
• Serve as a backup for operations management in their absence.

Qualifications:

• Bachelor’s degree in Engineering (Chemical preferred) or related technical discipline.
• Experience in a regulated manufacturing environment (GMP preferred).
• Experience in supervising teams within a manufacturing setting.
• Strong knowledge of process engineering principles, root cause analysis, and Lean manufacturing.
• Expertise in mixing, coating, and finishing processes is a plus.
• Familiarity with process validation, cleaning validation, and regulatory requirements.
• Proficiency in software applications such as Excel, Word, PowerPoint, and statistical analysis tools.
• Strong communication skills, with the ability to present technical information to various audiences.
• Comfortable working in environments requiring personal protective equipment.