Sterile Manufacturing Operator Trainer

Position Summary

Sterile manufacturing excellence starts with world-class training. As a Sterile Manufacturing Operator Trainer for a Food and Drug Administration (FDA) 503B outsourcing facility, you will play a critical role in shaping the skills, precision, and compliance of our manufacturing team, ensuring the highest quality standards in producing life-changing medications. At Empower Pharmacy, you will be part of a mission-driven organization dedicated to expanding access to quality, affordable medication while fostering a culture of innovation, continuous improvement, and professional growth.

Duties and Responsibilities

• Ensures all sterile manufacturing personnel receive thorough and effective training on current Good Manufacturing Practices (cGMP), aseptic techniques, gowning procedures, environmental monitoring, and operational protocols to maintain compliance with FDA 503B regulations and internal quality standards.
• Develops and continuously improves training programs, standard operating procedures, and hands-on instruction to enhance operator competency, minimize human error, and optimize efficiency in sterile compounding processes.
• Leads by example in maintaining a culture of quality, safety, and compliance, reinforcing best practices through regular coaching, performance evaluations, and corrective action plans to uphold the highest manufacturing standards.
• Collaborates with quality assurance, production, and regulatory teams to identify training gaps, implement process improvements, and ensure alignment with evolving industry standards, regulatory expectations, and internal operational goals.
• Manages training documentation, competency assessments, and ongoing qualification programs to ensure all sterile manufacturing operators are consistently trained, monitored, and equipped to produce high-quality compounded medications with precision and compliance.
  
  

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 workday 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.

Knowledge and Skills

• Exceptional communication, leadership, and coaching skills, with the ability to train, motivate, and hold team members accountable while fostering a culture of quality, safety, and continuous improvement.
• Extensive knowledge of aseptic techniques, cleanroom behavior, environmental monitoring, gowning procedures, and current Good Manufacturing Practices (cGMP), with proven experience leveraging artificial intelligence to enhance compliance, streamline workflows, and drive data-informed decision-making.
  
  

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  
  

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
  
  

Experience And Qualifications

• Minimum of 3 years of experience in sterile pharmaceutical manufacturing, aseptic processing, or a related field, with hands-on experience in training, mentoring, and ensuring compliance with FDA 503B regulations and cGMP.
• Requires a high school diploma or equivalent, with a strong preference for an associate or bachelor’s degree in a science-related field such as microbiology, chemistry, or pharmaceutical sciences.
• cGMP certification – Preferred; Aseptic Processing and Sterile Manufacturing Training Certification – Strongly Preferred; Certified Quality Technician (CQT) or equivalent – Preferred; Lean Six Sigma Certification (Yellow Belt or higher) – Preferred; Train-the-Trainer Certification – Strongly Preferred.
  
  

Benefits

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/