Training Certification Specialist | 1st Shift (Monday-Friday)
About The Position
The Training Certification Specialist ensures personnel are trained and qualified in aseptic gowning, aseptic behaviors, contamination control practices, cleanroom operations, and interventions to strengthen aseptic processing performance and product sterility assurance. This role involves developing, coordinating, and administering aseptic training and certification programs, delivering various training formats, and evaluating personnel competency. The specialist also performs routine observations and audits of personnel in cleanroom environments, monitors compliance, documents observations, and supports investigations related to aseptic deviations. Additionally, they coach employees on aseptic practices, serve as a subject matter expert, and partner with management to identify training needs. The position requires a High School diploma, with an Associate's degree in science or a related field preferred, and strong organizational, communication, and problem-solving skills. A minimum of 4 years of pharmaceutical cleanroom experience, program management, knowledge of aseptic techniques, training design and delivery, and cGMPs are required.
Requirements
- High School diploma.
- Associate’s degree in science or related field preferred.
- Detail oriented, highly organized.
- Able to maintain confidentiality.
- Effective written and verbal communication skills.
- Possess interpersonal skills, time management and follow through abilities.
- Effective problem solver with solid leadership abilities.
- 4+ years pharmaceutical cleanroom experience.
- Program management experience.
- Thorough knowledge of proper aseptic techniques.
- Experience in training course design and delivery.
- Knowledge of cGMPs.
- Must be authorized to work for ANY employer in the U.S.
Responsibilities
- Develop, coordinate, and maintain aseptic training and certification programs.
- Deliver instructor-led classroom training, practical demonstrations, virtual reality training modules, and hands-on assessments.
- Conduct new hire aseptic qualification training for personnel requiring cleanroom access.
- Support and administer annual recertification programs and retraining activities.
- Evaluate personnel competency through written exams, practical assessments, and observation-based audits.
- Coordinate operator qualification and certification activities associated with media fills and aseptic interventions.
- Maintain certification records and training databases.
- Perform routine observations and audits of personnel working in Grade A/B and Grade C/D environments.
- Monitor compliance with gowning requirements, aseptic technique, cleanroom behaviors, and contamination control procedures.
- Document observations and provide coaching, corrective actions, and follow-up training when deficiencies are identified.
- Support investigation activities related to aseptic technique deviations and environmental monitoring trends.
- Coach employees on aseptic practices, contamination prevention, first-air protection, and cleanroom discipline.
- Serve as a subject matter expert for aseptic processing and contamination control.
- Partner with supervisors and managers to identify training needs and performance gaps.
- Promote a culture of quality, compliance, and continuous improvement.
- Support department projects as assigned.
- Perform other tasks, projects, and duties as assigned.
Benefits
- Employee Benefits: Bausch + Lomb
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
