Aseptic Training Program Manager

Responsibilities

• Design, develop, and maintain comprehensive aseptic training program that aligns with current regulatory standards, industry best practices, and company-specific requirements.
• Create training materials, including standard operating procedures (SOPs), e-learning modules, presentations, and other resources related to aseptic techniques and practices.
• Develop a structured training curriculum for all new hires and ongoing education for existing staff on aseptic techniques, contamination control, and GMP (Good Manufacturing Practice) compliance.
• Support all department leadership in developing successful training programs for all current and incoming team members based on their specific work requirements and functions.
• Conduct aseptic training sessions for employees, including classroom-based training, hands-on workshops, and on-the-job training.
• Coordinate with department heads, supervisors, and other training team members to schedule and prioritize training sessions based on operational needs and compliance requirements.
• Lead aseptic gowning, cleanroom behavior, aseptic manipulations, and other specific training programs for employees working in critical environments.
• Ensure all training programs meet regulatory requirements (e.g., FDA, EMA, cGMP, ISO standards) and internal quality policies.
• Ensure accurate records of training completion, competency assessments, and refresher courses are maintained.
• Prepare training documentation for audits, inspections, and regulatory reviews.
• Evaluate the effectiveness of training programs through assessments, feedback, and audits.
• Develop and implement continuous improvement initiatives to enhance the quality and impact of aseptic training programs.
• Monitor employee performance and provide corrective action as necessary to ensure compliance with aseptic standards.
• Collaborate with cross-functional teams (e.g., Quality Assurance, Operations, Engineering) to address specific aseptic training needs and challenges.
• Serve as the subject matter expert for aseptic practices and provide guidance to managers and employees regarding aseptic technique requirements.
• Communicate regularly with senior leadership regarding training progress, challenges, and improvements.
• Maintain training records, competency assessments, and certification documentation in compliance with internal and regulatory requirements.
• Prepare and present regular training program reports to management, highlighting achievements, compliance status, and areas for improvement.

Qualifications

• Bachelor’s degree. A degree in Life Sciences, Engineering, Quality Management, or a related field preferred. A master’s degree is a plus.
• 5+ years of experience in aseptic manufacturing, quality assurance, or a related field, with at least 2 years in a training or leadership role.
• Proven experience in the development, delivery, and management of training programs in regulated environments (e.g., pharmaceuticals, biotechnology).
• In-depth knowledge of aseptic techniques, contamination control, cGMP guidelines, and relevant regulatory standards.
• Strong training and instructional design skills, with experience developing both classroom and practical training materials.
• Excellent communication, presentation, and interpersonal skills.
• Strong problem-solving and organizational skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), and Learning Management Systems (LMS).