Process Engineer II

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following :

• Support the execution of the Commissioning, Qualification, and Validation activities for our new Vial Filling system (e.g., washing / depyrogenation, aseptic filling, isolator / VPHP, glove integrity testers, environmental monitoring systems), including SAT, IQ / OQ, PQ, and Aseptic Process Simulation.
• Management of Equipment Vendors, including project execution, on-site maintenance and calibration visits, vendor-supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts criticality assessments.
• Responsible for delivering cycle development for the process including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation for filling process and recipes.
• Support the establishment of an electronic batch record system for filler and isolator setup, operation, and changeover.
• Support the transition from project to sustaining manufacturing and the ramp-up of production volumes in the future by improving equipment reliability through Continuous Improvement and TPM processes.
• Coordinate technical deliverables within the Aseptic Operations team to support successful process and product launches.
• Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Manage change in the Vial Filling and / or Nest Filling areas as per site change control procedures.
• Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).

BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

PREFERRED QUALIFICATIONS