JOB SUMMARY

The incumbent is responsible for assisting the Validation Manger in completion of all project milestones as well as manufacturing support. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).

ESSENTIAL JOB FUNCTIONS

• Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
• Review and approve qualification documentation on behalf of the validation department.
• Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
• Support investigations into protocol nonconformances and site deviations.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Author standard operating procedures related to validation practices.
• Support the execution and generation of formal risk assessments.
• Support the generation and implementation of validation programs.
• Experience working in clean rooms.
• Experience with aseptic fill finish technique.

EDUCATION/CERTIFCATIONS/LICENSES

• A minimum of a Bachelors degree in Engineering preferred

ON-THE-JOB EXPERIENCE

• 5-8 years of validation experience

KNOWLEDGE, SKILLS AND EXPERIENCE

• The ability to communicate with employees of all experience levels
• The ability to report on project activity in a clear and concise manner
• The ability to communicate with fellow project team members
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office, Excel, and Visio
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Ability to manage multiple activities with challenging timelines
• Able to access crawl spaces and use ladders to access equipment.