Training Specialist

Role Overview

• Train technicians to execute the specific process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
• Deliver cGMP, technical training which includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment.
• Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
• Demonstrate to new staff how to perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs and safety regulations.
• Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
• Work with the Manufacturing team to evaluate personnel training needs.
• Coordinate new hire manufacturing training with Manufacturing Management and the Training Department as required to ensure assignment and completion in LMS.
• Coordinate cross training of existing staff with Manufacturing Management.
• Assist in reviewing and revising documents as a result of deep understanding of manufacturing processes.
• Assist in deviation investigations, CAPAs, risk assessments and change controls.

Requirements

• Bachelor's degree with at least 2 years of experience working in a cGMP environment in the biotech or pharmaceutical industry
• Biotechnology certificate with 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry
• Mastery of Vericel’s Manufacturing procedures – Minimum of 2 years of successful Vericel Manufacturing Process Experience
• Demonstrated success as a Qualified Trainer for at least three (3) aseptic processing operations
• Proven ability to provide feedback in a coaching manner while maintaining the integrity of the SOP and regulatory requirements
• Strong experience with PowerPoint, Word and Excel.
• Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.

Benefits

• Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.