Process Engineer II

Job Description

We are searching for a Process Engineer with experience in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system technology, and single-use fluid path components. The VA facility, which is nearing completion, will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines.

During the project phase, you will primarily manage OEMs and engineering services providers through commissioning, qualification, and validation and lead process development for two recently installed high-speed filling lines. During the operational phase, you will be the System Owner / SME of a high-speed filling line, optimizing equipment uptime and process robustness as we continue to transfer products currently produced by contract manufacturing sites, fulfilling Client's mission to "Do what's in the best interest of patients."

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