Job Overview
This is a pivotal role where you will be responsible for the development and optimization of aseptic pharmaceutical manufacturing processes, ensuring adherence to regulatory standards. As part of our cross-functional team, you will collaborate to enhance efficiency, scale up processes, perform new product introductions (NPIs), and troubleshoot manufacturing challenges.
Main Responsibilities
* Develop, optimize, and implement robust, scalable, and cost-effective pharmaceutical manufacturing processes.
* Conduct process risk assessments, document findings, and implement risk-mitigation strategies.
* Lead investigations into deviations, non-conformances, and root cause analyses to identify and rectify issues.
* Support scale-up, technology transfer, ASQ, and commercialization of new products by designing study protocols, generating reports on outcomes, and providing technical expertise.
Requirements
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
* A minimum of 3-7 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
* At least 2 years' experience in sterile injectables or biologics manufacturing, with a strong understanding of relevant regulations and industry standards.
* Six Sigma or Lean Manufacturing certification.
* Familiarity with automation systems, process analytical technology (PAT), and data analysis tools.