Qualification Senior Engineer

Primary Responsibility

• Lead and/or participate in project teams for process and facility equipment qualification, process/packaging validation, cleaning validation and commercial production support activities.

• Coordinate process and facility equipment qualification activities to meet project/compliance due dates and product launch dates.

• Execute process and facility equipment qualification activities such as FATs, SATs, installation, operational and performance qualifications, equipment periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, CAPA, etc. for standard to complex equipment.

• Independently determine approaches to resolve complex technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.

• Prepare, review, approve and/or execute documents to support projects and investigations such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, change control, etc.

• Provide process/packaging validation and commercial production support when needed such as protocol execution and batch monitoring, investigation of manufacturing incidents, qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, hold time studies, etc.

• Perform cleaning validation activities when needed such as execution of cleaning validation and verification studies, hold time studies, swab sampling, investigations, assessments, justifications, etc.

• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.

• Represent Technical Services at project team meetings and provide sound technical advice.

• Coordinate and communicate with Operations, Facility Engineering and Quality Assurance groups and with Piramal clients and vendors to assure successful project execution and provide technical expertise.

• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.