GxP Training Facilitation Specialist, 2nd or 3rd Shift
$86,944,000–$114,816,000 year
On-siteFishers, Indiana, United States
Job Summary
Conduct classroom and on-the-job training for new hires and ongoing employee development, delivering instruction on GxP principles, quality systems, and regulatory requirements. Administer uniform learning assessments, evaluate trainee competency, and track learning outcomes within the eQMS. Mentor employees, provide constructive feedback, and collaborate with cross-functional departments to ensure effective knowledge transfer and compliance. Maintain accurate training records and support audit preparation while identifying opportunities to improve training effectiveness. Work flexible second or third shift hours to accommodate operations.
Required Qualifications
- Minimum 2-3 years of hands-on training delivery, instructional facilitation, and/or on-the-job training (OJT) experience
- Must pass health and visual check and eye inspections annually for visual acuity and color blindness
- Demonstrated practical knowledge of GxP manufacturing and regulatory requirements for pharmaceuticals, including understanding of FDA 21 CFR Parts 11 and 211 and ICH GxP guidelines
- Demonstrated knowledge of pharmaceutical manufacturing processes and/or related GxP operations; hands-on experience in or working knowledge of regulated manufacturing environments
- Excellent verbal and written communication skills
- Demonstrated ability to explain complex technical and regulatory concepts clearly to diverse audiences with varying educational backgrounds and technical expertise
- Proven mentoring and coaching skills demonstrating ability to assess, evaluate, develop, motivate, and empower others
- Strong interpersonal skills and demonstrated ability to build trusting relationships
- Ability to develop, implement, and analyze uniform learning assessments
- Skilled in evaluating trainee performance and providing constructive feedback
- Self-motivated, detail-oriented individual with strong organizational skills
- Ability to manage training schedules, maintain accurate records, meet deadlines, and balance competing priorities in a fast-paced environment
- Ability to adapt to diverse learners and delivery situations
- Strong customer service mindset and ability to work collaboratively across functional areas and with multiple departments
- Must be authorized to work in the United States on a full-time basis
Desired Qualifications
- Bachelor's degree in life sciences, pharmaceutical sciences, education, quality assurance, or related field
- Degree and/or professional certification(s) focusing on adult learning principles or training and development (e.g., Certified Professional in Training and Development [CPTD], Certified Training and Development Professional [CTDP], or equivalent)
- Hands-on instructional experience in a regulated manufacturing environment (pharmaceutical, medical device, biotech, etc.)
- Experience with learning management systems (LMS) and training documentation software, particularly Veeva Vault or similar eQMS platforms
- Background in quality assurance, compliance, regulatory affairs, or manufacturing operations
- Experience with FDA Form 483 observations or regulatory inspection findings related to training compliance
- Knowledge of CAPA (Corrective and Preventive Action) and deviation management processes
- Experience mentoring and developing employees in technical or operational roles
- Familiarity with instructional design principles and learning effectiveness methodologies
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