Aseptic Lead, Operations - Dublin

Job description

Job Description We’re looking for an experienced Aseptic expert who enjoys working hands‑on with teams to strengthen sterile manufacturing standards and build long‑term capability. You’ll be a trusted subject matter expert, shaping how aseptic practices are applied, improved, and sustained across the site. Responsibilities: - Lead the Environmental and Media Simulation Programs within the manufacturing area. - Develop and implement the Aseptic qualification process within the department. - Oversee compliance enhancement projects in clean room areas. - Manage the End-to-End Media fill program, including strategy, competency building, execution, and GMP Audit defense. - Develop and grow the Isolator Glove Management Program at the site. - Contribute to cleanroom operations and contamination control procedures, including cleaning, sanitization, garbing, and segregation. - Ensure compliance with our company’s global policies, procedures, guidelines, and regulatory requirements, executing cGMP in daily activities. - Provide SME insight during deviations or audit activities and serve as the manufacturing IPT lead in Sterile Council and Sterile CoP. Qualifications: Required: - Bachelor’s...