Aseptic Manufacturing Training Specialist

The Aseptic Manufacturing Training Specialist supports the manufacturing leadership team by delivering essential hands‑on training to all manufacturing employees. Additionally, the Manufacturing Training Specialist will be trained as a Subject Matter Expert (SME) in key foundational processes, which may include, but are not limited to, using pH meters, balances and scales, solution preparation, dispensing, gowning for Grade A/B and Grade C/D areas, and making aseptic tubing connections in aseptic and non‑aseptic areas.

• Develop and execute training programs for manufacturing employees, including onboarding, technical skills development, safety protocols, and continuous improvement initiatives.
• Support the Training Manager in assessing training needs through collaboration with Manufacturing department leaders, job analyses, and employee feedback.
• Create training materials such as standard operating procedures (SOPs), work instructions, e‑learning modules, and hands‑on training exercises.
• Conduct training sessions in various formats, including classroom instruction, on‑the‑job training, and virtual learning.
• Maintain training records and documentation to ensure compliance with regulatory requirements and company policies.
• Evaluate the effectiveness of training programs through assessments, feedback, and performance analysis, making necessary adjustments to improve learning outcomes.
• Partner with subject matter experts (SMEs) and leadership to ensure training content remains up‑to‑date with industry best practices, technological advancements, and compliance regulations.
• Support a culture of continuous learning and professional development within the manufacturing team.
• Assist in audits and regulatory inspections by providing training documentation and demonstrating adherence to training protocols.
• Provide assistance during aseptic media fills, as needed.

• Bachelor's degree in Education, Engineering, Scientific field, or a related field preferred.
• 2+ years of experience in training, quality assurance, or manufacturing role, within the pharmaceutical industry.
• Experience in developing and delivering technical training programs.
• Good knowledge of GMP and Regulatory requirements as related to aseptic manufacturing.
• Strong understanding of manufacturing processes, safety standards, and quality control principles.
• Excellent communication, presentation, and interpersonal skills.
• Ability to adapt training methods to suit diverse learning styles and technical expertise levels.
• Detail‑oriented with strong organizational and record‑keeping abilities.
• Ability to work a non‑standard work schedule as needed.
• Ability to work on weekends, off shifts and holidays as business demands.
• Basic computer skills, including familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS).

• Prolonged periods of standing in a manufacturing area or sitting at a desk and working on a computer.
• Must be able to lift up to 40 pounds at times.
• Able to gown for Grade A/B, Grade C/D and wear a respirator without any restrictions.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.