Aseptic Process Trainer

Shift: Day Shift, Monday-Friday, 8:00am - 4:30pm

Vacancy Status: This position is currently vacant

AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

The Aseptic Process Trainer is responsible for designing, delivering, qualifying, and continuously improving aseptic training programs to ensure personnel competence in aseptic behaviors, gowning, interventions, and contamination control. The role is critical to maintaining sterility assurance, regulatory compliance, and inspection readiness.

Key Role Specific Requirements

• Develop, implement, and maintain the aseptic training curriculum for sterile injectable manufacturing.
• Ensure training programs align with:
  • EU GMP Annex 1 (2022)
  • FDA Aseptic Processing Guidance
  • PIC/S and internal CCS requirements
• Maintain role-based aseptic training matrices for all sterile area personnel.

Practical Aseptic & Gowning Qualification

• Conduct and assess:
  • Initial and periodic gowning qualifications (Grade A/B/C)
  • Aseptic technique training and observation
  • Material transfer and intervention simulations
• Perform post-gowning and aseptic technique environmental monitoring assessments.
• Define and enforce pass/fail criteria and requalification requirements.

Media Fill & Aseptic Qualification Support

• Ensure personnel participation and qualification in:
  • Initial and routine aseptic process simulations (media fills)
• Support planning and execution of media fills from a training and personnel qualification perspective.
• Assess operator performance during media fills and recommend retraining where required.

Training Effectiveness & Continuous Improvement

• Evaluate training effectiveness using:
  • Environmental monitoring trends
  • Gowning qualification results
  • Media fill outcomes
  • Aseptic deviation trends
• Initiate targeted retraining and behavioral coaching based on data.
• Periodically review and update training materials based on:
  • Regulatory updates
  • Inspection findings
  • Internal deviations and CAPAs

Documentation & Inspection Readiness

• Maintain compliant training records, including:
  • Training attendance
  • Assessments and qualifications
  • Gowning and aseptic observation records
• Support regulatory inspections and audits by:
  • Presenting aseptic training systems
  • Defending training effectiveness and qualification decisions
• Contribute to CCS documentation related to personnel and training.
• Act as a qualified aseptic trainer, maintaining own aseptic and gowning qualifications.
• Support train the trainer programs for supervisors and SMEs.
• Coach operators and supervisors on aseptic behaviors and contamination risk awareness.

Cross Functional Collaboration

• Work closely with:
  • Manufacturing
  • QA Microbiology
  • Engineering & Maintenance
  • QA / Sterility Assurance
• Support change control, investigations, and risk assessments related to aseptic operations.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

FOSTERING COLLABORATION/TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

TECHNICAL COMPETENCIES - Strong knowledge of Aseptic processing principles, Contamination control strategies, Cleanroom classifications and airflow, Environmental monitoring, Gowning systems, and sterile garments. Deep understanding of EU GMP Annex 1 (2022) expectations. Root cause analysis and CAPA related to aseptic failures.

BEHAVIOURAL & PROFESSIONAL - High attention to detail and strong observation skills, ability to challenge poor aseptic behaviors constructively, excellent communication and coaching skills, strong GMP mindset and quality culture advocate and confident interacting with inspectors and auditors.

Other Requirements

• Microbiology
• Pharmacy
• Biotechnology
• Life Sciences or related discipline
  (Advanced degree desirable)
• Minimum of 5 - 8 years' experience in a Sterile Injectable Manufacturing
• Minimum 3 years' hand on experience in: Aseptic fill finish operations and Grade A/B gowning requirements.
• Proven experience delivering Aseptic training and qualification.
• Direct involvement in media fills and EM programs.
• Familiar with Clean room technology and RABS filling systems.
• Thorough understanding of Contamination Control Strategies.
• Understanding of Sterilization methods.
• Exposure to Virtual Reality Aseptic simulations
• Familiar with Visual Particulate Inspection methods.
• Ability to work in the evenings and weekends as required.
• Previous experience interacting with FDA and Health Canada representatives.
• Certified Training Practitioner (CTP) or Certified Training and Development Professional (CTDP)
• This role will require access to the cleanroom environment and Aseptic gowning qualification.
• Competitive vacation policy effective upon hire.
• 13 paid holidays.
• Defined Contribution Pension plan with employer matching 5%.
• Employee Assistance Program.
• Expected Salary Range: $75,000 - $100,000 per year.

Benefits

Competitive vacation policy effective upon hire. 13 paid holidays. Defined Contribution Pension plan with employer matching 5%. Employee Assistance Program. Expected Salary Range: $75,000 - $100,000 per year.

Equal Opportunity & Accessibility

At Bimeda we are committed to fostering an inclusive, barrier free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. We are committed to an inclusive and accessible recruitment process. We are an equal opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.