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.