The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation
Job Summary
The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.
Key responsibilities include defining contamination control strategy, overseeing EM and Media Fill programs, leading aseptic training, and implementing risk assessments.
The company offers competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits, along with outstanding career and development prospects.
Matching Summary
The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.
Skills & Requirements
Must-have
Contamination control strategy
Environmental Monitoring program
Media Fill Program oversight
Aseptic Comportment/Training/Oversight
Sterilization processes oversight
Risk assessments and improvement programs
Investigate Sterility Assurance issues
Nice-to-have
Subject Matter Authority
Client-facing roles
Interpersonal skills
Diplomacy and assertiveness
Independent judgment
Key Requirements
Bachelor of Science Degree in Microbiology, Applied Biology, or similar
7 years of Microbiology experience
5 years of leadership experience
Experience in pharmaceutical quality function
Knowledge of aseptic process simulations (media fills)
Familiarity with U.S. FDA, EU Annex-1 regulations
Work Rights
Must be legally authorized to work in the United States