Commercial Manufacturing - Technical Trainer

Minaris • Allendale, NJ

10d • Onsite

About The Position

Position Summary Serves as primary technical trainer in order to facilitate and conduct on-the-job for both the effective induction of new hires as well as, the ongoing improvement and proficiency (i.e.; cross-training) of personnel within the department, by delivering on-the-job technical training on a timely basis. Shift and schedule for this role is: Monday - Friday: 8:00am - 4:30pm Essential Functions and Responsibilities Demonstrates knowledge of learning and development delivery in an aseptic cell therapy manufacturing environment. Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing personnel evaluations or proficiency assessments during production activities Actively monitors personnel’s technique and application of learning and provides feedback to trainees as well as to managers. Facilitates timely resolution and closeout of corrective and preventative actions specific to technical training. Creation and revision of Unit Operation Training for Onboarding Skillsets consisting of but not limited to User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos and Final Assessments in collaboration with site partners. Creation and revision of Client Specific training content consisting of but not limited to User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos and Final Assessments in collaboration with Subject Matter Experts (SMEs). Escalates training related initiatives for Operational Excellence (OE).Participates in and/or contributes to advanced business process workflow activities.Actively engaging in learning and development methodologies offerings (webinars, conferences, authoring tools, on demand learning). Knowledge, Skills and Abilities Organized and capable of successfully managing multiple priorities using effective time management techniquesAbility to present and communicate effectively. Must be accountable for work product and demonstrate strong work ethic. Qualifications Bachelor’s in Life Science or L&D and 3+ years of experience in cGMP environment or High School Diploma or Equivalent with 5-7 years of experience in cGMP manufacturing environment. Knowledge of aseptic techniques and skills, contamination control, testing methods, and cleanroom behavior. Knowledge of biopharma laboratory and/or manufacturing experience. Knowledge of cGMP and GDP. 1+ years of experience in a training role preferred (particularly On-The-Job Training).Able to pass aseptic gowning qualification Computer software skills including Microsoft Office. Self-motivated and able to work efficiently with minimal supervision. Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail oriented, willingness to “roll up sleeves” and do the work required for success. Experience using authoring and Learning development tools, i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Lectora, Camtasia, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere. Quality Requirements Build Quality into all aspects of your work by maintaining compliance to all quality requirements. Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function). Attend all required Quality & Compliance training at the specified interval. Minimum Required TrainingFor Technical Trainers supporting cleanroom activities: Gowning Qualification Aseptic Techniques Aseptic Processing Standards Technical Trainers supporting cleanroom activities must be able to comply with Minaris personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role. Working Environment Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens Must be able to handle the standard/moderate noise of the manufacturing facility This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Physical Requirements The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully. The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance). Gowning proficiency as needed. An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods. Gowning proficiency as needed. Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator. Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone. Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice

Requirements

• Organized and capable of successfully managing multiple priorities using effective time management techniques
• Ability to present and communicate effectively.
• Must be accountable for work product and demonstrate strong work ethic.
• Bachelor’s in Life Science or L&D and 3+ years of experience in cGMP environment or High School Diploma or Equivalent with 5-7 years of experience in cGMP manufacturing environment.
• Knowledge of aseptic techniques and skills, contamination control, testing methods, and cleanroom behavior.
• Knowledge of biopharma laboratory and/or manufacturing experience.
• Knowledge of cGMP and GDP.
• Able to pass aseptic gowning qualification
• Computer software skills including Microsoft Office.
• Self-motivated and able to work efficiently with minimal supervision.
• Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail oriented, willingness to “roll up sleeves” and do the work required for success.
• Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Attend all required Quality & Compliance training at the specified interval.
• For Technical Trainers supporting cleanroom activities: Gowning Qualification Aseptic Techniques Aseptic Processing Standards
• Technical Trainers supporting cleanroom activities must be able to comply with Minaris personal hygiene standards as they apply to aseptic processing.
• The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role.
• Must have the ability to work in a team-oriented environment and with clients
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
• Must be able to handle the standard/moderate noise of the manufacturing facility
• This role operates within a professional office environment of a manufacturing operations plant.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Seating is mixed and includes open space seating, cubicle, and office space.
• The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
• Gowning proficiency as needed.
• An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.
• Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand.
• Must be able to exchange accurate information in person, and on the telephone.

Nice To Haves

• 1+ years of experience in a training role preferred (particularly On-The-Job Training).
• Experience using authoring and Learning development tools, i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Lectora, Camtasia, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere.

Responsibilities

• Demonstrates knowledge of learning and development delivery in an aseptic cell therapy manufacturing environment.
• Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing personnel evaluations or proficiency assessments during production activities
• Actively monitors personnel’s technique and application of learning and provides feedback to trainees as well as to managers.
• Facilitates timely resolution and closeout of corrective and preventative actions specific to technical training.
• Creation and revision of Unit Operation Training for Onboarding Skillsets consisting of but not limited to User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos and Final Assessments in collaboration with site partners.
• Creation and revision of Client Specific training content consisting of but not limited to User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos and Final Assessments in collaboration with Subject Matter Experts (SMEs).
• Escalates training related initiatives for Operational Excellence (OE).
• Participates in and/or contributes to advanced business process workflow activities.
• Actively engaging in learning and development methodologies offerings (webinars, conferences, authoring tools, on demand learning).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level