Manufacturing Training Specialist Houston Texas
The Role: Manufacturing Training Specialist
Location: Houston, Texas
HireBetter’s client is the country’s most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. They currently serve more than 3.5 million patients across the United States.
The Manufacturing Training Specialist is responsible for developing and implementing training programs and processes that equip manufacturing personnel with the knowledge and skills required to meet the rigorous standards of sterile drug production under 503B regulations.
- Designs, develops, and implements comprehensive training programs that align with 503B sterile manufacturing regulations and guidelines
- Designs training materials, programs, modules, and assessments to ensure cohesive understanding and competence among manufacturing staff
- Regularly updates training content to reflect the latest industry standards and regulatory changes
- Provides training on Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory requirements
- Oversees gowning qualification processes, including training and evaluation, to maintain aseptic gowning standards
- Develops and executes training modules related to media qualification, ensuring technicians can perform these tasks accurately and efficiently
- Maintains accurate and up-to-date training records, including documentation of training completion and certifications
- Collaborates with Quality departments and Manufacturing management to ensure training materials support compliance efforts
- Conducts hands-on training sessions for manufacturing personnel, including aseptic techniques, cleanroom procedures, and equipment operation
- Supervises, facilitates, and assesses trainees in controlled sterile manufacturing environments and or simulated areas to ensure proficiency and safety
- Develops and implements methods to assess the competency and effectiveness of training programs
- Monitors and evaluates employee performance to identify areas for improvement and additional training needs
- Stays updated on industry trends, best practices, and regulatory changes related to sterile manufacturing
- Collaborates with cross-functional teams to implement process improvements and enhance training programs accordingly
- Promotes a culture of safety, quality, and compliance within the manufacturing team
- Collaborates on root cause analysis and provides training-based solutions to prevent errors and deviations in manufacturing processes
- Maintains clear communication with manufacturing staff, trainers, and management regarding training initiatives and progress
- Monitors and analyzes KPIs related to training, including training effectiveness, compliance, and technician performance, and provide regular reports to leadership
- Performs other duties as assigned
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.The requirements listed above are representative of the knowledge, skill, and/or ability required.Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the work day and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices.The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employee will regularly be exposed to areas in which moving mechanical parts, fumes, toxic chemicals are present. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employee may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision.
- Bachelor’s degree in a relevant field (Pharmaceuticals, Life Sciences, or Education). Advanced degrees or certifications in Pharmaceutical Sciences or Training & Development are a plus
- 3-5 years prior experience in pharmaceutical manufacturing and sterile compounding, with a focus on aseptic techniques and cleanroom operations
- Proven experience in designing and delivering effective training programs in a pharmaceutical manufacturing environment
- Strong understanding of 503B sterile manufacturing regulations and FDA cGMP guidelines
- Detail-oriented with the ability to maintain accurate records and documentation
- Strong problem-solving skills and the ability to adapt to changing regulatory environments
- Communicates effectively, both verbally and written, with personnel at all levels in a professional manner
- Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook
- Knowledge of Learning Management Systems (LMS) and training software
Interested candidates should apply through the HireBetter website at jobs.hirebetter.com. Qualified applicants will be responded to as quickly as possible.
Please note: Applicants for employment in the U.S. must possess work authorization that does not require sponsorship for a visa now or in the future.