Production Trainer - GMP/Packaging

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

As a Production Trainer - GMP/Packaging you are responsible for managing organizational compliance surrounding annual training with a focus on ensuring production employees are trained, competent, and operating in full compliance with cGMP/cGDP standards. The Production Trainer - GMP/Packaging will design and deliver structured training programs with a focus on tactical production skills, support onboarding and skill development, and serve as a key link between Quality, Operations, and Continuous Improvement.

This is a highly hands-on role, combining classroom instruction, administrative oversight, floor-based training, and real-time coaching. The Production Trainer will actively observe operations, identify gaps, and continuously enhance training programs to drive consistent, high-quality execution across production.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.
• Hours may vary based on training needs.

Responsibilities

Training Program Development

• Develop structured, cGMP/cGDP-compliant training programs for production roles.
• Build curricula, training modules, and skill-development pathways.
• Create and revise training materials based on process updates, audit findings, and continuous improvement efforts.

Training Delivery & Coaching

• Facilitate onboarding and foundational training for new production employees.
• Deliver hands-on, floor-based training to reinforce proper execution of procedures.
• Track trainee progress and identify learning gaps.
• Provide targeted coaching and remedial training to achieve performance standards.

Training Documentation & Compliance

• Maintain accurate, complete, and compliant training records for all on-site training.
• Perform periodic reviews of annual training requirements to ensure documentation meets cGMP/cGDP requirements.
• Ensure traceability and alignment with validated processes.

Production Floor Support

• Provide real-time coaching to reinforce safety, quality, and procedural adherence.
• Partner with supervisors and line leaders to maintain role certifications and performance standards.

Continuous Improvement Integration

• Collaborate with Operations to integrate process improvements into training.
• Monitor performance metrics, error trends, and training effectiveness.
• Recommend improvements to workflows, training methods, and documentation.

Collaboration & Influence

• Work closely with Production, Quality, and Leadership teams.
• Support corrective action efforts through targeted training initiatives.
• Influence performance and behavior without direct authority.

Qualifications

• Bachelor's degree in a life science, training and development or related field preferred or 10+ years of relevant experience.
• 3+ years of experience creating and delivering training in a cGMP-regulated manufacturing environment preferred.
• 3+ years of hands-on experience in production, manufacturing, or pharmaceutical operations required.
• 3+ years of experience in a cGMP environment is required.
• Experience in pharmaceutical packaging or regulated manufacturing environments preferred.
• Familiarity with LMS or training tracking systems preferred.
• Experience developing comprehensive training materials, SOPs, or technical work instructions preferred.
• Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.

Knowledge, Skills, and Abilities

• Demonstrated ability to train, coach, and mentor employees effectively.
• Excellent communication skills with the ability to simplify complex processes.
• Strong attention to detail and ability to maintain accurate documentation.
• Ability to work independently and maintain strong floor presence.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.