MSAT Lead

• You will be responsible for ensuring the continual process robustness in all manufactured products at the site by incorporating expectations and actions in the process engineering team's LDM (Learning Development Matrix).

• Your role includes overseeing the closure of incidents and investigations with effective CAPA, addressing root causes to prevent repeat incidents.

• Your role involves reviewing the qualification of equipment and cleaning procedures to ensure robustness and documenting learnings to create an organizational knowledge repository.

• Additionally, you will collaborate with cross-functional teams to conduct risk assessments for all production processes, considering process, personnel, and environmental safety.

• You will recommend and support improvements, including actions such as P&ID (piping and instrumentation diagram and URS (User Requirement Specification) preparation, procedure development, and addressing safety risks.

• You will initiate Management of Change (MOC) and Pre-Startup Safety Review (PSSR) processes to ensure the fulfillment of recommended changes and enhance process safety.

• You will be responsible for continuous improvements in quality, removal of bottlenecks in production capacity, batch cycle times, yield improvements beyond budgets, technologies, and waste reduction.

• You will be responsible for fostering cross-learning within the Process Engineering community under the MSAT (Manufacturing Science and Technology) umbrella. This involves actively participating in and driving opportunities for knowledge exchange that arise from being part of a larger fraternity.

• Your role includes learning from experiences at other sites and sharing insights gained from associated sites.

• You will be responsible for developing common solutions for platform issues impacting multiple sites and creating best practices for the FTOs (Formulation Technology Organization--- Injectables).

• Your role involves assessing opportunities and implementing changes related to scale-up and modifications in processes/equipment at various stages of product development.

• You will interact with cross-functional teams (CFT) and prepare risk assessments for any modifications or changes.