Process Improvement Specialist (Formulation / Filling)

Accentuate Staffing is assisting a growing pharmaceutical distributor in the Morrisville area who is hiring a Process Improvement Specialist (Formulation / Filling) to join their manufacturing team. This is a fantastic direct hire opportunity working on 1st shift, 8am-5pm, Monday-Friday. Responsibilities : Partner with Manufacturing, Quality, Engineering, and Supply Chain teams to optimize processes in compounding, aseptic filling, and visual inspection. Serve as a subject matter expert (SME) for formulation / filling operations, providing on-the-floor technical support to maintain high-quality aseptic practices. Lead and support investigations for manufacturing deviations, identify root causes, and drive corrective and preventive actions (CAPAs). Develop, update, and maintain SOPs, batch documentation, risk assessments, and change controls to ensure process compliance and continuous improvement. Analyze production data and performance trends to identify process inefficiencies and recommend improvements to fill line capability, training, and documentation. Conduct operator training and qualification activities, reinforcing proper aseptic and cleanroom techniques in alignment with regulatory standards (Annex 1, USP, CFR 210 / 211, ICH). Support equipment qualification, material readiness, and sampling programs to ensure timely and compliant production. Participate in audits, client visits, and internal reviews, providing technical expertise and operational insights. Requirements : Bachelor’s degree in a scientific or engineering field with 2+ years of sterile injectable manufacturing experience Minimum 1 year of technical writing experience (SOPs, deviations, batch records, etc.). Demonstrated leadership, training, and process improvement experience in a regulated cGMP environment. Strong understanding of cGMP, GDP, aseptic technique, and cleanroom behavior. Hands-on experience with compounding, filtration assemblies, isolator filling systems, and autoclaves. Excellent communication and interpersonal skills with the ability to train and mentor others effectively. Analytical thinker with strong problem-solving, documentation, and organizational skills.