50% Training Design and Delivery
- Design & develop training content and materials for technical training for the Manufacturing organization at FDBT based on unit operations.
- Solicit input from Manufacturing and Quality leadership and develop a training roadmap to align with the technical training needs and delivery for the organization in the first 12 – 18 months in the position.
- Work directly with FDB sites to incorporate already established unit operational theory based training into the FDBT training plan.
- Develop specific unit operation areas for training at FDBT.
- Conducts needs assessment & task analysis to support training recommendations including reviewing CAPA items to identify deficiencies.
- Maintain, deliver, facilitate and continuously improve training including instructor-led sessions, qualifications, and on-line self-paced courses.
- Identify appropriate training schedules to support the Manufacturing organization.
- Work directly with source Subject Matter Experts at FDBT and across the FDB network on the development of the training material.
- Revise materials to keep pace with learning best practices and technical changes.
- Monitor industry and regulatory trends to ensure that relevant training meets current specifications.
- Apply adult learning principles and company design methodology to training materials.
- Assist area management with development and maintenance of job-specific curricula for their areas.
- Assist area management with deviation investigations involving training related topics and human error issues.
- Leverage best practice from other FDB sites and implement technician certification program at FDBT.
25% GMP Compliance
- Represent Manufacturing training compliance during audits
- Ensure compliance of training programs and systems for skills based training program.
- Administer various functions within the Learning Management System (LMS)
25% Training Assessment
- Evaluate training courses for effectiveness using trainee feedback, area management discussions, deviation reports, etc. as sources of information and implement improvements.
- Work with FDB sites to implement unit operation knowledge tests and hands on execution to become certified, qualified and SME’s for various established unit operations.
- Provide additional training for those employees who do not successfully qualify.
- Develop and deliver to timelines, service level agreements, and instructional design projects.
- Develop assessment methodologies.
- All other duties as assigned.
Required Skills & Abilities:
- Ability to develop strategic relationships; strong verbal and written communication skills.
- Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
- Ability to work effectively under extreme pressure to meet deadlines.
- Flexibility and strong organizational skills with the ability to handle multiple activities simultaneously.
- Proven success in leading complex projects and bringing them to conclusion.
- Excellent knowledge of concepts, practices, and procedures related to the biotechnology industry.
- Self-discipline and excellent attention to detail.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Bachelor’s Degree (preferably in a science related field) and 4 years’ relevant training experience, OR
Associates Degree (preferably in a science related field) 6 years relevant training experience, OR High School Diploma and 10 years relevant training experience
- Working knowledge of laboratory and/or manufacturing instruments/equipment
- Lean Six Sigma certification and experience
- Previous leadership experience
- Experience with the operation of Biotech/pharmaceutical process equipment in a process development or cGMP manufacturing environment.
- Demonstrated experience developing, conducting and evaluating training programs.
- Prior experience administering functions of a learning management system