Process Engineer

Role Summary

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.

Responsibilities

• Prepare validation protocols and reports for manufacturing process and cleaning process qualification, data analysis, and prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
• Managing the post approval projects, coordinating with cross-functional teams and ensuring the timely completion of projects.
• Analyzes statistical data, products or functional specifications to determine conformance with standards and established quality requirements.
• Coordinate/oversee the development of new processes or troubleshoot existing ones.
• Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) and assist in various audits.
• Initiation of Change Controls and Planned Deviations when required.

Qualifications

• Experience: 2 years or more in Pharmaceutical/Manufacturing Industry
• Specialized Knowledge: Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

Education

• Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required
• Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred

Skills

• Excellent verbal and written communication skills - Advanced
• Proficiency in MS Word/Excel/ PowerPoint/MS Project - Advanced