Teams at ISPV Inc.

The role involves overseeing the planning and execution of pharmaceutical facility projects, ensuring adherence to GMP and safety regulations, managing stakeholders, and controlling costs.

Perform commissioning, qualification, and validation (IOQ, PQ, functional tests) of manufacturing and laboratory equipment; author and review technical documents and reports; manage quality systems (deviations, change control) and maintenance documentation (PMs, work orders, job plans); ensure process and cleaning validation documentation is reviewed and approved.

Support regulated biotech/pharma manufacturing by applying process engineering and automation knowledge to troubleshoot issues, implement CAPA, drive continuous improvement (Lean Six Sigma/Kaizen), ensure cGMP compliance and documentation, and collaborate with operations, quality, and maintenance teams to optimize production.