BioNetwork Capstone Center
Closes: Thursday, December 31, 2020
Target Start Date
Expected Work Hours
Master's degree preferably in a life science, chemistry, regulatory science, biopharmaceutical sciences or related field
Ten years of experience working in a cGMP regulated, medical product (pharmaceutical, medical devices, biologics) manufacturing environment within either a validation or quality assurance capacity
Ability to travel 20% annually
Valid Driver's License
Fifteen years preferred working in a cGMP regulated, medical product (pharmaceutical, medical devices, biologics) manufacturing environment within either a validation or quality assurance capacity
Experience supervising a team
Experience functioning in a leadership role while performing project execution
Experience in creating and delivering training programs within community college environment
Pay Grade: Professional 8
The Industry Trainer, Validation and Quality Systems develops courses and training programs for clients including customized training departments within the NCCCS, biotech companies from across the state of North Carolina, NC universities and colleges, the Food and Drug Administration (FDA), and international bio manufacturing companies.
This position is part of a state-wide Bionetwork program funded by the North Carolina Community College System. Wake Technical Community College serves as the fiscal agent for this position. Daily operational and supervisory activities are conducted and managed by North Carolina Community College System personnel.
Most postings are open for a limited time, depending upon the number of applications received. When the stated closing date is "Continuous", please apply immediately. The position may close without notice.
Responsibilities and Duties (*Essential Functions):
To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the primary job functions herein described.
*Develop new lecture material and course modules including course syllabi, presentation slides, team activities and assessments catered to college, company and student needs
*Deliver hands-on, industry specific workforce development courses to customers as a Subject Matter Expert (SME) in Validation and Quality Systems such as Current Good Manufacturing Practices for Pharmaceuticals and Medical Devices, Fundamentals of Validation, Good Documentation Practices for Pharmaceuticals and Medical Devices , and ensure training meets best practices according to current OSHA, Food and Drug Administration (FDA), ISO and European Union (EU) regulations, and USP, WHO, ISPE and PDA Guidance
*Oversees adjunct industry trainers to include hiring supervision, assignments, scheduling, coordinating training activities, goal setting, and evaluations
*Statewide responsibility to work with Customized Training Directors (CTDs) and their respective community colleges to determine industry training needs and execute course delivery
Research, design and develop class and laboratory activities relevant for assigned courses on processes related to manufacturing of medical products such as quality systems and validation.
Develop the Validation Academy Certificate Program
Works with management and cross-functional teams to strategically plan a training roadmap of future training and development needs and participates in meetings and committees with industry clients and other stakeholders
Maintains effective working relationships with industry representatives, BioNetwork colleagues, community college staff and the general public
Serves as a representative of BioNetwork to promote the Validation Academy at industry related conferences and meetings, biomanufacturing forums and advisory boards
Promotes continuous improvement by completing an annual applied benchmark project on an individual or a group basis
Knowledge, Skills & Abilities:
Exceptional written and oral communication skills
Exceptional organizational and time management skills; ability to multi-task with demonstrated commitment to follow-through expeditiously
Strong interpersonal and leadership skills
Ability to work effectively both independently and in a team environment
Knowledge of principles and methods for curriculum and training design, teaching, and instruction for individuals and groups and the measurement of learning transfer
Ability to select training/instructional methods and procedures appropriate for the intended audience
Ability to analyze and interpret regulatory guidelines
Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
Proficiency in Microsoft Office and the use of internet resources
Willingness to learn and expand knowledge base