Job description
Mantell Associates is partnered with an expanding organisation in search for a Aseptic Training Manager.
Responsibilities:
Develop Aseptic Training program for August Bio that instructs personnel on gowning, aseptic technique and expected work conduct to maintain sterility in the classified areas of the facilityDevelop attainable training plans for new employees (Manufacturing, Engineering, QC, Sanitation, EM), as applicable
Train new and existing employees on Aseptic training program as applicable
Ensure existing colleagues maintain their certifications by scheduling and performing training, as applicable
Plan and provide overall support for Aseptic Media Fills
Develop/improve/update necessary training materials
As Aseptic SME, perform necessary Aseptic assessments
Responsible for maintaining working knowledge of current Good Manufacturing Practices (cGMPs) and emerging regulatory and compliance concerns as related to aseptic manufacturing
Work with cross-functional groups to improve the current Aseptic, Sanitation and EM training programs
Requirements:
A bachelor’s degree in a relevant field
6+ years’ experience in an aseptic environment supporting aseptic manufacturing
Excellent communication (oral/written), facilitation and presentation skills
Good knowledge of GMP and Regulatory requirements as related to aseptic manufacturing
Self-directed and capable to make and act upon decisions that impact the site from an aseptic standpoint
Able to assess training needs for individual and area
Experienced in aseptic gowning and aseptic techniques
Experienced in pharmaceutical sanitation and disinfection techniques
Technical Training experience in a lab or manufacturing environment
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.
