CEL - Specialist Training Development
Specialist Training Development
Job Number: 21-03160
Job Number: 21-03160
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Specialist Training Development for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The Training & Development Specialist is responsible for the successful implementation of the site Manufacturing Training Program.
- The Specialist assists in determining training solutions that adhere to the Site Training Program.
- This position trains other staff members, as well as assesses their ability to perform tasks proficiently.
- The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed.
- Requires a high level of understanding of cell therapy processes, cleanroom manufacturing, and GMP requirements.
- Intermediate sills in design, development, and 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 qualification program.
- Implements training programs that meet regulatory requirements & business needs including:
- Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.
- Works with the Manager on an on-going basis to implement training goals and meet KPI's.
- Conducts ILT and OJT sessions to ensure cleanroom operators are proficient.
- Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
- Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
- Collaborates with the Manager to ensure training is compliant and effective.
- Maintains accurate training documentation and employee record keeping.
- Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
- Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
- Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
- Develops / implements new course content as procedures change or as new techniques are introduced.
- Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
- Implements the local Manufacturing Operations new hire Training Program including:
- Promotes and exhibit core Client values in onboarding and training activities.
- Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.
- Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
- Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
- Communicates with different departments to ensure new hires have access to all necessary systems and security.
- Maintains the training status of new hires and communicates progress to Department Management.
- Maintain the Training Laboratory and equipment for cleanliness and compliance.
- Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
- Run daily calibration checks on equipment where appropriate and escalate deviations.
- Perform routine cleaning of laboratory areas and equipment.
- Ensure sufficient laboratory supplies for daily training activities.
- Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed):
- Execute/Implement batch records in ISO 7 & 8 clean room environments.
- Observe, practice, and promote all aspects of the GMP & GDP requirements.
- Complete and maintain aseptic processing and sterile gowning qualifications.
- Communicate with Quality Control to ensure proper handoff of process samples.
- Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
- Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
- Reports and initiates non-conformances and participates in follow up investigation when necessary.
- Performs all other duties as required.
- Education and Experience: B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 3-5 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
John Bayog | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.