Steriles University Training Specialist III

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Company Information

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit . 

Group/Division Summary

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

Position Summary

The Steriles University Training Specialist III is responsible for supporting the development and delivery of the required introductory cGMP Steriles Manufacturing and Device Assembly Manufacturing Training for all new hires that will work in Steriles Manufacturing and Device Assembly Manufacturing environments utilizing a customized Virtual Reality program, instructor led training, and the Thermo Fisher Scientific's Learning Management System (LMS) ensuring compliance to regulatory agency regulations and procedural requirements. This position is responsible for supporting and continuously improving the Steriles University Training Program by working directly with all levels of Steriles Manufacturing and Device Assembly Manufacturing leadership staff to establish assignment profiles and curriculums based on assigned roles and functions.

Key Responsibilities:

• Facilitate Steriles University classroom training including new hire and annual training.
• Manage the design and development, classroom, eLearning, and On the Job Training (OJT) material based on user requirements.
• Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices.
• Manage semi-annual review with Steriles Leadership/Management of new and existing training materials to ensure proper transfer of knowledge to trainees and the organizations readiness to meet company objectives and growth.
• Maintain all Steriles University support systems.
• Host corporate, customer, and/or educational site tours of the Training Center.
• Supports new hire orientation event
• Leads projects and training initiatives that drive quality, compliance and operational effectiveness for the organization
• Maintain consistent communication with network counterparts for best practice sharing
• Deploys the use of professional documentation and training development authoring tools to aide in the building and maintenance of instructional modules. 
• Administers training assessments to evaluate the progress of the trainee and identify any learning gaps that require further training.
• As a process SME that maintains a detailed knowledge, ensure SU Training team is aware of the training process history, compliance, operations, changes, and deviating events.
• Assists with evaluations of the effectiveness of training programs and learning outcomes.
• Documents and provides reports on progress of training outcomes to management.
• Partners with Device Assembly Manufacturing Subject Matter Experts to develop training materials and provide guidance in the development and implementation of a consistent training program.
• Partners with Steriles Operations Subject Matter Experts to develop training materials and provide guidance in development and implementation of a consistent training program.
• Complies with all job-related safety and other training requirements.
• Work in a safe and responsible manner to create an injury-free and incident free workplace.
• Performs other duties as assigned 

Qualifications:

*Must be Legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check to include drug screening.

Education/Experience:

• Associates degree in Education, Business, Technical discipline, or related field with 7+ years of experience in cGMP steriles manufacturing and/or device assembly manufacturing environments, LMS systems, and training experience required.
• Bachelor's degree in Education, Business, Technical discipline, or related field with 5+ years of experience in cGMP steriles manufacturing and/or device assembly manufacturing environments, LMS systems, and training experience preferred.
• Requires a high level of understanding of steriles manufacturing and device assembly manufacturing processes, controls, and GMP requirements, so 7+ years of steriles manufacturing and/or device assembly manufacturing technical experience in at least 3 process areas is strongly preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Advanced understanding of training, instructional design, communication and/or education.
• Advanced functional and process knowledge to support the integrated design and development of training programs.
• Advanced coaching ability to support a variety of learning styles and approaches when delivering training to adult learners.
• Excellent verbal, written, and interpersonal communication skillsStrong speaking and presentation skillsStrong interpersonal and relationship building skills
• Strong commitment to customer service trainingStrong proficiency with computer operating systems and software skills (i.e. Microsoft Office applications, LMS,...)
• Advanced project and time management skills
• Must be skilled in decision-making, building relationships, problem solving, planning, and organizing.
• Must be able to work independently.
• Understanding of distribution process along with awareness of regulatory documentation requirements.Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
• Ability to lead cross-functional project teams.

Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it.

Competitive wages & Excellent benefits package

• Review our company’s  Total Rewards
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 6%(after 1 year)
• Tuition Reimbursement – eligible after 90 days
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• We will provide the vital equipment for your role including: computer, monitor, keyboard, mouse, etc.
• We also provide any Personal Protective Equipment you may need including: lab coats, safety glasses, safety shoes, etc.

For more information on our benefits, please visit: