Process Improvement Specialist (Formulation / Filling)

Job Description

Accentuate Staffing is assisting a growing pharmaceutical manufacturer 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.

Qualifications