Job Title: Process Specialist
Overview
We are seeking a highly skilled Process Specialist to support the introduction of new products and process development activities within a regulated manufacturing environment.
Key Responsibilities
* Perform gap analyses, facility fit assessments, process safety reviews, and risk analyses for new product introductions.
* Assist in developing and optimizing manufacturing processes for new products.
* Support process transfers into GMP manufacturing facilities.
* Monitor, trend, and analyze manufacturing process data to ensure process control and performance.
* Lead or support risk assessments such as PFMEA and EHS risk reviews.
Technical Support & Documentation
* Provide operational technical support for process-related issue resolution.
* Prepare, review, and update specifications for NPI-related materials and consumables.
* Develop NPI documentation including transfer plans, protocols, procedures, and batch manufacturing records.
* Lead or support product and process investigations, change controls, and CAPA activities.
Cross-Functional Collaboration
* Work closely with global science, quality, and operations teams to support process development and technology transfer.
* Support, supervise, and train manufacturing personnel on NPI processes and single-use technologies.
Compliance
* Ensure all work complies with GMP, safety, and EHS standards, policies, and procedures.