Manufacturing Technical Trainer
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POST DATE 9/17/2016
END DATE 12/4/2016
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The Manufacturing Technical Trainer position performs a wide variety of technical duties to support manufacturing operations and training. This position is responsible for providing manufacturing technical and floor support and developing / delivering NASD training, especially manufacturing training, to ensure personnel safety and regulatory compliance at Agilent Technologies Nucleic Acid Solutions Division at 5555 Airport Blvd., Boulder Colorado, 80301 USA.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
* Develop and continually improve NASD training program, including developing, maintaining, and executing training rubrics to ensure compliance with quality, environmental, health and safety requirements, and industry best practices. Responsible for streamlining procedures; updating/revising training rubrics, SOP's and other training documentation; and making recommendations for process / procedural / system improvements. Serve as a primary point of contact for review and / or revision of training materials when associated procedures are revised.
* Evaluate existing training materials for efficacy, and support revisions when needed to ensure training is clear, consistent, and effective. Lead the effort to develop new training materials for Manufacturing operations, with support from Subject Matter Experts, QA, Manufacturing Engineers, PD, and others.
* Complete all Manufacturing training and become a Qualified Trainer on all manufacturing operations. Complete training in other departments, as requested and feasible, and become a Qualified Trainer on their systems / operations, if requested and feasible.
* Participate in manufacturing activities and identify process improvement and optimization opportunities. Develop project plans for process improvements and lead implementation of process improvements.
* Assist manufacturing with problem solving and trouble-shooting process or process equipment issues, including collaborating with various NASD teams to develop solutions and resolve issues to meet production timelines, quality policies, and customer expectations.
* Support Manufacturing Qualified Trainers by minimizing their training workload; provide Task Observation Training, Skill Demonstration Training, and / or Multi-Step Training to trainees. Support Qualified Trainers in other departments by providing training for or with them when possible. (Technical Trainer will only provide training on tasks for which the Technical Trainer is a Qualified Trainer).
* Actively lead or participate in the investigation of major process deviations, especially as related to training and human performance issues, including providing technical assistance to QA on the final product impact assessment and identification of root cause as necessary.
* Interface with Process Engineering and Facilities on the required manufacturing equipment specifications to support equipment modifications or the procurement of new equipment, especially as it relates to human performance and human machine interaction.
* Participate in the process hazard analyses (PHA) for new or modified manufacturing processes and equipment as assigned. Support the implementation of corrective actions as necessary.
* Collaborate with Manufacturing Management, Project Management, Business Development, Chemical Development and Engineering regarding manufacturing capabilities and other considerations regarding new and existing manufacturing projects, especially as they impact, or are impacted by, personnel training.
* Work with the Manufacturing Systems Coordinator, Project Management group and Manufacturing department management to project and take advantage of upcoming training opportunities.
* Support the execution of equipment qualification protocols for manufacturing equipment a required.
* Actively participate with internal and external regulatory audits and inspections as required.
* Assess training needs for new and existing Manufacturing staff members. Develop individual training plans where needed, taking into account each individual s level of education and experience, and leveraging opportunities for training based on the production schedule and availability of Qualified Trainers.
* Assist Manufacturing Systems Coordinator, as needed, to ensure training records for personnel are current, correct, and complete. Support maintenance of training files, as needed.
* Work with Manufacturing Systems Coordinator to track and report on training outcomes. Help develop a method for reporting training needs, training performed, and training results.
While performing the duties of this job, the employee may be required to stand for long periods of time and may frequently be required to sit for long periods of time. The employee is occasionally required to stand; walk; use hands to touch, handle, or feel; reach with hands and arms; stoop, kneel, climb ladders, crouch, or crawl; and talk or listen. The employee must occasionally lift and / or move up to 50 pounds. This position may be required to work evenings and weekends.
The employee may be working with moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.
NOTE: The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required by personnel so classified.
EDUCATION and/or EXPERIENCE:
Bachelor's or Master's degree in a scientific discipline and 2+ years of experience supporting GMP training, or an equivalent combination of education and experience.
Experience working in pharmaceutical manufacturing and specifically in oligonucleotide manufacturing is preferred but not required.
KNOWLEDGE, SKILLS, AND ABILITIES:
To perform this job successfully, an individual must be able to execute each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Knowledge of processes and equipment utilized to manufacture oligonucleotide APIs such as, but not limited to: Solid Phase Oligonucleotide Synthesis and Deprotection, Chromatography Purification (AX, RP, HIC, etc.), Ultrafiltration, Conjugation, Annealing and Lyophilization.
* Have knowledge of scientific principles, theories and laboratory practices of chemical and applied sciences. Have the ability to participate and / or lead investigations applying scientific methods and effectively present findings and solutions to customers, co-workers, or members of management.
* Ability to work with interdisciplinary project teams to identify upcoming production needs, meet associated training requirements, optimize project timelines, and develop technical solutions to ensure that API production schedule is maintained.
* Knowledge of Good manufacturing Practice (GMP) guidelines as well as international regulations (i.e., International Conference on Harmonization [ICH] Q7) pertaining to the production of active pharmaceutical ingredients (API) and drug protocols.
* Proficiency in using computer software (hardware) applications, including manufacturing equipment and Microsoft Office software: Excel, Word, and PowerPoint. Familiarity with scheduling software and