Manufacturing - Training & Development Specialist - TechDigital
Summit, NJ
About the Job
100% onsite
PURPOSE AND SCOPE OF POSITION:
This position trains other staff members, as well as assesses their ability to perform tasks proficiently. This position
may also perform cleanroom processing duties as a Manufacturing Operator as needed.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Requires a high level of understanding of cell therapy processes, controls, and GMP
requirements.
• Intermediate skills in implementation of training.
• Advanced skills in using Microsoft Word, PowerPoint and Excel.
• Requires a high level of organizational and time management skills.
• Ability to communicate information clearly to facilitate effective learning. This position
requires speaking in classroom settings.
• Requires strong interpersonal skills which enable appropriate collaboration with
trainees, colleagues, and subject-matter experts.
• Ability to work in an aseptic environment requiring successful completion of aseptic
qualification program.
Education and Experience:
• B.S. in Biology, Biochemical, Chemical, or Biomedical
Engineering or related discipline with 1-3 years of relevant
experience in a clinical laboratory or blood/cell culture
processing environment.
DUTIES AND RESPONSIBILITIES:
• Implements training programs that meet regulatory requirements & business needs
including:
o Conducts ILT and OJT sessions to ensure cleanroom/manufacturing operators
are proficient.
o Provides feedback to trainees to ensure all skills/knowledge have been
acquired and communicates any skill/knowledge gaps that require additional
training.
o Solicits feedback from trainees to ensure the appropriateness of course
content, and for continuous improvement opportunities.
o Maintains accurate training documentation and employee record keeping.
o Performs competency assessments of operators on an ongoing basis to
ensure the knowledge/skills from training are continuously applied.
• Implements the local Breyanzi Manufacturing Operations Training Program including:
o Promotes and exhibit core Client values in training activities.
o Performs administrative tasks such as scheduling training sessions, ordering
training supplies, coordinating enrollment, and completing documentation.
o Conducts ITL/OJT structured trainings for new hires to introduce to aseptic
processing and GMP space, and process training.
o Maintains the training status of new hires and communicates progress to
Department Management.
• Maintains the Training Laboratory and equipment for cleanliness and compliance.
o Completes room activity, maintenance, cleaning, and equipment usage logs
(as required).
o Runs daily calibration checks on equipment where appropriate and escalate
deviations to area management.
o Performs routine cleaning of laboratory areas and equipment.
o Ensures sufficient laboratory supplies for daily training activities.
o Maintains training area organized according to 5S principles.
• Routinely participates in processing of cellular therapeutic products on the shop floor
(as needed):
o Executes/Implements batch records in clean room environments.
o Observes, practices, and promotes all aspects of the GMP & GDocP
requirements.
o Completes and maintains aseptic processing and sterile gowning
qualifications.
o Communicates with Quality Control to ensure proper handoff of process
samples.
• Reports and initiates non-conformances and participates in follow up investigation
when necessary.
• Performs all other duties as required.
Lab w/ blood & animal
Position Handles Hazardous Material
WORKING CONDITIONS :
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for
extensive walking, standing and occasional lifting of heavy materials. Frequent visual
demands require macroscopic and microscopic observations.
Employees must work in areas where posted Universal Precautions must be observed
and practiced. Associates work daily with potentially harmful and/or hazardous agents
including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable
chemical reagents and sharps.
This job description is intended to describe the general nature and level of work being
performed by the person assigned to this position. The primary duties and responsibilities
are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and
responsibilities assigned to this position. There are other duties and responsibilities that
are considered incidental or secondary to the overall purpose of this job. Employees
holding this position will be required to perform any other job-related duties as requested
by management.
PURPOSE AND SCOPE OF POSITION:
This position trains other staff members, as well as assesses their ability to perform tasks proficiently. This position
may also perform cleanroom processing duties as a Manufacturing Operator as needed.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Requires a high level of understanding of cell therapy processes, controls, and GMP
requirements.
• Intermediate skills in implementation of training.
• Advanced skills in using Microsoft Word, PowerPoint and Excel.
• Requires a high level of organizational and time management skills.
• Ability to communicate information clearly to facilitate effective learning. This position
requires speaking in classroom settings.
• Requires strong interpersonal skills which enable appropriate collaboration with
trainees, colleagues, and subject-matter experts.
• Ability to work in an aseptic environment requiring successful completion of aseptic
qualification program.
Education and Experience:
• B.S. in Biology, Biochemical, Chemical, or Biomedical
Engineering or related discipline with 1-3 years of relevant
experience in a clinical laboratory or blood/cell culture
processing environment.
DUTIES AND RESPONSIBILITIES:
• Implements training programs that meet regulatory requirements & business needs
including:
o Conducts ILT and OJT sessions to ensure cleanroom/manufacturing operators
are proficient.
o Provides feedback to trainees to ensure all skills/knowledge have been
acquired and communicates any skill/knowledge gaps that require additional
training.
o Solicits feedback from trainees to ensure the appropriateness of course
content, and for continuous improvement opportunities.
o Maintains accurate training documentation and employee record keeping.
o Performs competency assessments of operators on an ongoing basis to
ensure the knowledge/skills from training are continuously applied.
• Implements the local Breyanzi Manufacturing Operations Training Program including:
o Promotes and exhibit core Client values in training activities.
o Performs administrative tasks such as scheduling training sessions, ordering
training supplies, coordinating enrollment, and completing documentation.
o Conducts ITL/OJT structured trainings for new hires to introduce to aseptic
processing and GMP space, and process training.
o Maintains the training status of new hires and communicates progress to
Department Management.
• Maintains the Training Laboratory and equipment for cleanliness and compliance.
o Completes room activity, maintenance, cleaning, and equipment usage logs
(as required).
o Runs daily calibration checks on equipment where appropriate and escalate
deviations to area management.
o Performs routine cleaning of laboratory areas and equipment.
o Ensures sufficient laboratory supplies for daily training activities.
o Maintains training area organized according to 5S principles.
• Routinely participates in processing of cellular therapeutic products on the shop floor
(as needed):
o Executes/Implements batch records in clean room environments.
o Observes, practices, and promotes all aspects of the GMP & GDocP
requirements.
o Completes and maintains aseptic processing and sterile gowning
qualifications.
o Communicates with Quality Control to ensure proper handoff of process
samples.
• Reports and initiates non-conformances and participates in follow up investigation
when necessary.
• Performs all other duties as required.
Lab w/ blood & animal
Position Handles Hazardous Material
WORKING CONDITIONS :
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for
extensive walking, standing and occasional lifting of heavy materials. Frequent visual
demands require macroscopic and microscopic observations.
Employees must work in areas where posted Universal Precautions must be observed
and practiced. Associates work daily with potentially harmful and/or hazardous agents
including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable
chemical reagents and sharps.
This job description is intended to describe the general nature and level of work being
performed by the person assigned to this position. The primary duties and responsibilities
are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and
responsibilities assigned to this position. There are other duties and responsibilities that
are considered incidental or secondary to the overall purpose of this job. Employees
holding this position will be required to perform any other job-related duties as requested
by management.
Source : TechDigital
