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GxP Training Facilitation Specialist Summary

INCOG is seeking a highly skilled GxP Training Facilitation Specialist to deliver and execute comprehensive training programs across INCOG operations. This role is critical to ensuring that all personnel possess the knowledge, skills, and competencies needed to perform their duties safely and in full compliance with FDA and ICH GxP expectations.

The Facilitation Specialist will be responsible for conducting classroom training and on-the-job training (OJT), assessing trainee progress and competency, mentoring employees, implementing training assessments, and collaborating with departments to ensure effective knowledge transfer and compliance. Working from existing training curricula and materials, the specialist will focus on engaging delivery, learning facilitation, and ensuring training effectiveness. The ideal candidate is someone who demonstrates exceptional instructional skills, strong interpersonal abilities, and a passion for developing people while maintaining rigorous quality and compliance standards.

This is an off- shift position

Second Shift (2:00-10:30pm) or Third Shift (10:00pm-6:30am) based on preference

Essential Job Functions:

• Training Delivery & Facilitation: Conduct and deliver classroom-based training and on-the-job training (OJT) for new hires and ongoing employee development. Deliver engaging, clear instruction in GxP principles, quality systems, regulatory requirements, technical processes, and role-specific competencies. Adapt delivery methods and communication styles to diverse learning styles and technical backgrounds across multiple departments.

• Competency Assessment & Learning Evaluation: Develop and administer uniform learning assessments and tests. Assess and evaluate trainee progress, comprehension, and competency achievement. Analyze assessment results and identify individuals requiring remedial training or additional support. Track and report learning outcomes and training effectiveness metrics.

• Training Records & Documentation: Maintain complete and accurate training records and testing documentation within the eQMS in full compliance with FDA, ICH GxP, and INCOG requirements. Ensure traceability, completeness, legibility, and accessibility of all training records. Support preparation of training documentation for client and health authority audits.

• Mentoring & Coaching: Mentor and coach employees to support their development and competency achievement. Demonstrate strong coaching skills including the ability to assess, evaluate, develop, motivate, and empower learners. Provide constructive feedback and guidance to support continuous learning and professional growth.

• Curriculum Execution & Optimization: Execute approved training curricula and programs as designed. Identify opportunities for training delivery improvements and effectiveness enhancements. Partner with training leadership and subject matter experts to refine training methods and content clarity.

• Compliance & Best Practices: Ensure adherence to all regulatory, quality, and Environmental Health & Safety (EHS) requirements in all training activities. Maintain current knowledge of GxP principles, FDA guidance, and inspection findings related to training compliance. Serve as a resource for training-related inquiries and best practices.

• Cross-Functional Collaboration: Develop and maintain collaborative relationships with trainees, peers, colleagues, and internal clients across the organization. Work closely with multiple departments to understand their training needs and ensure effective knowledge transfer. Communicate training progress and compliance status to relevant stakeholders.

• Training Program Support: Review training progress and collaborate with departments to develop action plans for improving training compliance and competency achievement. Participate in training continuous improvement initiatives and process enhancements. Support onboarding programs to ensure consistent, timely training delivery for new hires.

• Self-Directed Learning & Development: Maintain and continuously improve personal training delivery skills through professional development. Stay informed about instructional best practices and adult learning principles. Participate in training team meetings and professional development opportunities.

• Flexible Scheduling: Work flexible hours and schedules to accommodate training delivery needs across INCOG operations.

• Other Duties as Assigned: Support additional Quality and operational initiatives as needed to advance organizational excellence.

Special Job Requirements: 

• Training Experience: Minimum 2-3 years of hands-on training delivery, instructional facilitation, and/or on-the-job training (OJT) experience

• Visual Check: Must pass health and visual check and eye inspections annually for visual acuity and color blindness. Failure in vision test or annual recertification could result in termination.

• GxP & Regulatory Knowledge: 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

• Pharmaceutical/Manufacturing Background: Demonstrated knowledge of pharmaceutical manufacturing processes and/or related GxP operations; hands-on experience in or working knowledge of regulated manufacturing environments

• Communication & Facilitation Skills: 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.

• Mentoring & Coaching Abilities: 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.

• Assessment & Evaluation: Ability to develop, implement, and analyze uniform learning assessments. Skilled in evaluating trainee performance and providing constructive feedback.

• Organizational & Detail Orientation: 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.

• Adaptability & Customer Service: 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.

Additional Preferences:

• 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

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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