Contamination Program Lead

Bachelor’s Degree – Preferably in Engineering or Microbiology
Greater than 8 years of experience in Technical, Engineering, and/or Operations in a GMP production environment
Experience conducting, supporting, reviewing and approving cleaning efficacy studies
Experience in biotechnology or Cell Therapy preferred
Experience with GMP equipment
Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
Strong organizational skills.
Strong microbial background and in-depth knowledge of cleaning / sanitizing agent and their impact on process, equipment and consumables
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively.
Experience with relevant regulatory requirements including in EU GMP Annex 1 inclusive of practical application.
Strong understanding of regulatory and compliance requirements
Excellent oral and written communication skills
Highly collaborative and inclusive
Ability to effectively mentor and coach junior team members
Language: English
Must be willing to work a hybrid schedule: (At least 3-4 days on site per week)

The Contamination Program Lead will establish and maintain the program / strategy for the site.
The role is responsible for ensuring the program aligns across sites in the network and responsible for presenting the strategy in health authority inspections.
Assess change controls, risk assessment, trend reports and SOPs/Work Instructions for contamination impact.
Support significant Environmental Monitoring and Sterility related investigations
Support Facility expansion activities including having a robust contamination approach and integration with the existing facility.
Support training of new and existing employees on the rational for proper contamination / disinfecting of equipment/personnel.