Process & Cleaning Validation Specialist, Technical Services

Description:

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.

Essential Functions:

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand 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 andestablished 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) & assist in various audits

Additional Responsibilities:

• Initiation of Change Controls and Planned Deviations when required