Aseptic Training Lead

Résumé du poste

The Aseptic Training Lead is responsible for developing and executing the site's aseptic and GMP technical training strategy to ensure workforce readiness. This role manages a training team and collaborates with cross-functional departments to maintain high standards of aseptic discipline and regulatory compliance.

Détails du poste

The APA Training Lead is responsible for leading the site’s aseptic and GMP technical training strategy, ensuring all employees are fully trained, qualified, and continuously developed to execute critical manufacturing activities in a highly regulated aseptic environment. This role leads a small training team and works closely with Manufacturing, Quality, Validation, and Technical Services to build and sustain a high-performing, compliant, and technically capable workforce. The role is central to ensuring workforce readiness, aseptic discipline, and operational excellence across all production activities. RESPONSIBILITIES: Aseptic Training Strategy & Leadership * Lead the site training function and manage a team of training professionals Aseptic & Technical Training Delivery * Oversee development and execution of hands-on aseptic training programs, including: * Aseptic technique and critical manipulation skills * Cleanroom behavior and contamination control practices * Gowning qualification and requalification programs * Media fill readiness and participation training * Training for critical process steps (e.g., filtration, filling, interventions) * Ensure robust on-the-job training (OJT) and structured qualification sign-offs * Partner with SMEs to ensure training reflects current processes, equipment, and manufacturing standards * Maintain ongoing operator proficiency and requalification programs Operational Integration & Support * Partner with Manufacturing and Quality to ensure workforce readiness for routine production, new product introductions, and process changes * Support aseptic process simulations (media fills) through training readiness and operator qualification * Align training execution with production schedules to minimize disruption while ensuring full capability * Support deviation investigations by identifying and addressing potential training gaps GMP Compliance & Systems * Maintain compliant training records, qualification matrices, and LMS documentation * Ensure all training programs meet GMP, regulatory, and internal quality standards * Support internal and external audits related to training and aseptic qualification systems * Drive adherence to standardized training processes and documentation practices Leadership & Team Development * Lead, coach, and develop a small training team to deliver high-quality training programs * Build strong cross-functional partnerships across Manufacturing, Quality, Validation, and Technical Services * Promote a culture of accountability, precision, and continuous improvement in training delivery * Develop and maintain a structured aseptic training and qualification system aligned with GMP and regulatory expectations * Ensure training governance supports consistent qualification of aseptic operators and cleanroom personnel * Embed contamination control principles and aseptic discipline across all training programs QUALIFICATIONS * Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field preferred * 5+ years of experience in GMP-regulated pharmaceutical manufacturing * Strong knowledge of aseptic processing and contamination control principles * Experience in technical training, GMP training systems, or manufacturing support roles * Prior people leadership experience is an asset COMPENSATION: The salary range: $80,000 - $115,000 annually This posting is for an existing vacancy. Pillar5 Pharma does not use AI at any stage of the recruitment or hiring process. Pillar5 Pharma is committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request throughout the recruitment and selection process. Benefits: * Company pension * Employee assistance program * Extended health care * Paid time off Work Location: In person

Ce que vous ferez

The Aseptic Training Lead is responsible for developing and executing the site's aseptic and GMP technical training strategy to ensure workforce readiness. This role manages a training team and collaborates with cross-functional departments to maintain high standards of aseptic discipline and regulatory compliance.

Exigences

Candidates should possess a bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field. A minimum of 5 years of experience in GMP-regulated pharmaceutical manufacturing with strong knowledge of aseptic processing is required.

Avantages

• Company pension • Employee assistance program • Extended health care • Paid time off

Compétences indiquées

• Validation · Souhaitée
• Assurance qualité · Souhaitée
• Leadership · Souhaitée
• Process Improvement · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Aseptic processing
• GMP compliance
• Technical training
• Contamination control
• Gowning qualification
• Media fill
• Leadership
• Quality assurance
• Validation
• Manufacturing support
• LMS documentation
• Audit support
• Process improvement
• Training strategy
• Cleanroom behavior
• Governance
• Operational Excellence
• Continuous Improvement Process
• Learning Management Systems
• Artificial Intelligence
• Pharmaceuticals
• Accountability
• Good Manufacturing Practices
• Team Building
• New Product Development
• External Auditing
• Technical Training
• Time Off Management
• Life Sciences
• Internal Auditing
• Training Delivery
• Technical Services
• Asepsis
• On-The-Job Training
• Contamination Control
• Training Records Management
• Pharmaceutical Manufacturing
• Filtration
• Aseptic Processing
• Deviation Investigations

Domaines d’emploi

• Manufacturing
• Healthcare
• Management & Leadership
• Science & Research
• Aseptic Technician
• Training and Development Manager
• Training and Staff Development Professionals
• Training and Development Managers