Aseptic Training Specialist

Charles City

Full time

JR00013038

Job Description:

This position is the primary site trainer for aseptic behavior, gowning qualification, and contamination control as it relates to aseptic manufacture of biologic products and materials. Designs, develops, and implements curricula, and conducts training for the Charles City biologics manufacturing site in compliance with site procedures and global standards.  Identifies and drives continuous process improvements related to aseptic training.  Conducts audits/reviews of personnel to evaluate training effectiveness. Assist with investigations related to aseptic processing.  Makes decisions that are in accordance with Company policies & SOPs, Zoetis Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

Position Responsibilities:

• Facilitate new employee aseptic training as well as refresher training for site personnel, including gowning qualification and routine process simulations.
• Coordinates required annual training requirements with department management
• Conducts spot checks/audits of aseptic techniques and behaviors during operations
• Observes sterile media fills (SMF) for aseptic practices and best practices.
• Network with the Global Aseptic Team to share best practices.
• Liaison with colleagues to ensure they are trained and understand the criticality of the aseptic process work they are conducting.
• Coordinates personnel training using available technology, including, but not limited to, virtual reality technology.
• Integrates training sessions and training documentation into electronic training document management systems.
• Spend time in the production environment, examining the processes and reviewing the data (example – environmental monitoring). Identify best techniques and practices to help reduce bioburden and contamination.
• Collaborate with area Manufacturing Team Leader to train and lead colleagues in the performance of best aseptic practices.
• Utilize subject matter knowledge related to Aseptic Processing in the conduct of training:

• Facility Design / Environmental Controls
  Cleaning and Disinfection (facility surfaces, equipment)
  • Aseptic and Controlled Area Gowning
  • Aseptic Training / Good Aseptic Technique
  • Material Transfer
  • Material/Personnel / Equipment Flow and Movement
  • Use of Isolator and Barrier Systems
  • Sterilization / Validation
  • Bioburden Reduction
• GMP/Regulatory Requirements
  Compliance Trends
  • Basic Industrial Microbiology
  • Types of Microorganisms
  • Growth and Reproduction
  • Sources of Cleanroom Contamination
  • Reduction/Elimination
  • Measurement Systems
  • Site Specific Data Trends and Metrics

Education and Experience:

• BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience related to aseptic manufacturing.  Bachelor’s Degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.

Technical Skills Requirements

• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.

• Familiar/proficient in adult learning methodologies
• Strong technical writing skills.
• Preferred experience in biological antigen production systems, biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
• A working knowledge of vaccine production methods and experimental design and experience in GLP or cGMP.
• Knowledge of APHIS, VMD, FDA, USDA regulations applicable to the Pharmaceutical/Biological industry.
• Preferred experience in Lean/Six Sigma

Physical Requirements

• Must be able to walk or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Able to become qualified to enter clean room environments.
• Work Environment: While performing the duties of this job, the employee occasionally works in clean room environments.  The noise of these work environments is typical office noise.