Aseptic Training Program Manager

The Aseptic Training Program Manager is responsible for overseeing the development, implementation, and management of training programs related to aseptic techniques, processes, and practices within the organization. This role ensures that all employees involved in aseptic operations are properly trained, maintain compliance with industry standards and regulatory requirements, and consistently perform at the highest level of competency in aseptic environments. The manager will also work closely with other departments to ensure the continuous improvement of aseptic practices within the company.

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).