Senior Technical Transfer Specialist
We are seeking an experienced professional to lead and execute process engineering and validation activities in a leading biopharmaceutical organization.
Responsibilities
* Evaluate and ensure compliance through documentation, risk assessments, and corrective actions.
* Develop and manage multiple technical engineering projects to support business growth, including process improvements, capital projects, and lean initiatives.
* Deliver technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team.
* Foster lean six sigma and standard work practices within the team.
* Cultivate collaboration between group functions and identify synergies.
* Provide subject matter expertise on equipment design, C&Q execution, and process requirements.
Requirements
* Significant experience in a comparable role, with process engineering and/or validation experience in a sterile manufacturing environment.
* In-depth knowledge of Sterile filling processes and equipment, especially aseptic processing.
* Experience executing and/or managing equipment and process validation in a sterile environment.
* Familiarity with shipping/Filter/Cleaning validation is required.
* Understanding of automation and MES systems.
* A proven track record of process improvement implementation and project management.
Skills and Qualifications
The ideal candidate will possess excellent communication and problem-solving skills, with the ability to collaborate effectively with cross-functional teams.
About the Job
This is an exciting opportunity for a skilled professional to drive business growth and improvement through effective process engineering and validation.