Validation Engineer will plan and schedule validation projects, including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGMP requirements. Provide support to the vendor’s installation and commissioning activities in a growing, fast paced environment for both Oral Solid Dose (OSD) and sterile products.
- Qualification of Oral Solid Dose (OSD) and Sterile manufacturing facilities.
- Maintain all documentation pertaining to qualification and validation.
- Experience in Equipment and Facility Validation and / or Qualification in GMP environment. This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
- Responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment.
- Generate equipment/cleaning validation documents.
- Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.
- Develop/review requirements and specifications.
- Able to follow-up and resolve comments, deviations, and technical issues.
- Generate/execute variety of commissioning and qualification protocols for pharmaceutical equipment (IQ, OQ, PQ).
- Must be able to work independently and in team environment.
- Must be able to lead project with minimal supervision.
- Coordinate the proper approval of plans, requirements, and protocols.
- Review completed protocols for completeness, cGMP compliance and data acceptability.
- Prepare validation summary and final reports.
- Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems.
- Develop a strong documentation package, involving form conceptual study to various phases of projects like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
- Qualification and documentation related to engineering department.
- Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
- Bachelor's degree in relevant scientific discipline required
- Hands-on experience in qualification of biopharmaceutical facilities as per cGMP requirements.
- Experience reviewing/development commissioning, qualification and validation.
- Excellent knowledge of pharmaceutical quality systems and Qualification practices.
- Strong understanding of aseptic filling unit operations, controls, and drug product process validation is highly desired; a good understanding of resource forecasting is also highly desired.