Validation Engineer II, Manufacturing Technical Services

Description:

Validation Engineer II, reports to Supervisor of Technical services or head of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills. Works as a team member, educates internal partners on the projects, monitors and executes. Review Master Production Records, Standard Operating Procedures, Change Controls, deviations and equipment qualification documents. Evaluate root cause of failures and out of specification results and provide and execute corrective and preventive actions. Maintains effective and cooperative relationships with all departments within and outside the organization.

Essential Functions:

• Prepare and review validation protocols for manufacturing process and cleaning process qualification; data analysis and prepare reports, schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines, analysis of ANDA
• Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements and prepare final reports;
• Execute post-approval change projects – strategy development, execution plan, data analysis and work with Regulatory team for submission
• Prepare and review manufacturing batch record and other engineering qualification documents as required, ownership of change controls, review Annual Product Review reports and plot trend analysis. Write technical services report for investigations.
• Provide training to cross-functional departments on technical part, provide training on protocols and oversee execution, coordinate and communicate all testing with affected functional groups and evaluates test results
• Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits
• Participate in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards, participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA )