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About the role
Key responsibilities & impact- Lead the training specialist team and partner with Operations, Engineering, EHS, and HR to design, deliver, and verify training effectiveness
- Own site training procedures and the training and qualification process
- Establish and maintain role-based training matrices and curricula
- Ensure GMP tasks are performed only by associates with current documented training and required qualifications
- Assign and track training for new and revised controlled documents
- Administer and maintain Learning Management System data integrity
- Ensure training records meet GDP and ALCOA+ principles and are audit-ready
- Assess training as a contributing or root cause in nonconformances, CAPAs, complaints, and audits
- Develop and execute training-related CAPA actions and verify effectiveness
- Trend human-error and training-related events and drive systemic improvements
- Design and maintain hands-on training content, job aids, videos, presentations, and structured on-the-job training
- Lead trainer selection, certification, and requalification
- Improve new-associate onboarding and ensure qualification before independent work
- Develop cross-training and certification programs with Operations, Engineering, and EHS
- Build and own a hands-on floor associate training program using demonstration and practice
- Implement standardized on-the-job training methods and proficiency levels
- Develop visual workstation training aids and support training cells or simulation stations
- Maintain skills/flexibility boards and conduct floor observations and Gemba walks
- Lead quality culture initiatives and embed quality behaviors in training
- Measure quality culture and report trends to leadership
- Build and harmonize the Pharma Center of Excellence training program for the El Paso and Sandy sites
- Lead training and qualification for site transformation projects
- Establish and report training KPIs
- Serve as training subject matter expert during audits and FDA inspections
- Perform self-inspections and close training-system gaps
- Lead, coach, and develop Training Specialists
- Report training compliance risks and issues to Quality and Operations leadership
Requirements
What you’ll need- Bachelor’s degree in a scientific, engineering, education, or related field
- Minimum 7 years of experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment
- At least 3 years in training, quality, or curriculum development
- Minimum 4 years of experience supervising or leading people
- Working knowledge of pharmaceutical cGMP (21 CFR Parts 210/211), 21 CFR Part 11, and Good Documentation Practices
- Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016
- Hands-on experience administering a Learning Management System
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Experience supporting FDA inspections and/or notified body audits preferred
- Experience with root cause analysis and CAPA, including human-error investigation methods, preferred
- Instructional design certification or training (e.g., ADDIE) and experience measuring training effectiveness preferred
- Lean / Continuous Improvement training experience; Green Belt preferred
- Experience building hands-on, floor-based training programs preferred
- Experience leading quality culture or employee engagement initiatives preferred
- Combination product (21 CFR Part 4) experience and knowledge of ICH Q7/Q9/Q10 and EU GMP / PIC/S preferred
- Experience with sterile or aseptic manufacturing training and qualification preferred
- Experience supporting multi-site programs, harmonization, or site transformation / change management preferred
- Bilingual English/Spanish preferred
- Compliance with local, state, federal, and BD safety regulations, policies, and procedures
Benefits
Comp & perks- Face-to-face collaboration culture
- Opportunities to learn, grow and thrive
- Equal opportunity employment