At Pharmaceutics International Incorporated, the business problem is to identify and develop technical solutions for process and cleaning validation to support production activities and ensure compliance with regulatory requirements.
Requirements
- Knowledge of or experience in analyzing validation data and conducting Risk Assessments
- Knowledge of or experience in writing and executing validation Protocols, Batch Records and Reports
- Knowledge of or experience in investigating and resolving manufacturing issues
Responsibilities
- Collaborate with Project Managers, clients, R&D, and other departments to identify and develop technical solutions for process and cleaning validation
- Create protocols, reports, and other required documentation to support production activities
- Manage the annual Cleaning Verification Program and draft Quality Risk Management Procedures to outline cleaning requirements for product acceptance
- Support the Media Fill Program by preparing protocols and reports, managing media fill history, and coordinating with Quality Assurance and Production teams
- Troubleshoot production issues with R&D and Production teams
- Assist with other validation projects based on priorities
- Implement recommendations to improve systems and drive Operational Excellence initiatives
Other
- Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering or a closely related field
- 24 months of experience as Process Validation Engineer or related
- Qualifications and experience, geographic location, education, external market data, and consideration of internal equity will be used to determine the actual offered rate
- Must be able to work in a team environment and communicate effectively with various departments
- Must be able to troubleshoot production issues and implement recommendations to improve systems
