Process Engineer III

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.