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 Degree or higher in Science, Engineering, or related technical discipline.
Minimum of 5 years’ experience in Drug Product and sterile manufacturing operations.
Experience with Media Simulations, either executing or coaching teams.
Knowledge of sterile filling processes and equipment, particularly Grade A Isolator.
Prior experience with GMP Audits.
Preferred
Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team‑oriented manner.
Excellent planning and organization skills to manage training programs, assessments, and cleanroom support.
Ability to align Aseptic team objectives with wider site goals and sterility assurance priorities.
Required Skills
Adaptability
Aseptic Operations
Contamination Control
Decision Making
Process Improvements
Process Simulation
Sterile Manufacturing
Training Program Management
EEO Statement
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
About the Company
Our cutting‑edge, state‑of‑the‑art vaccines facility in Dundalk site focuses on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products – strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry‑leading network.
Job Posting End Date: 06/23/2026
Requisition ID: R393773
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