Aseptic Lead
My client, a leading global pharmaceutical manufacturer based in Dundalk, is seeking an Aseptic Lead to spearhead their Contamination Control and Aseptic Programs. In this high-visibility role, you will act as the primary authority on aseptic excellence, driving capability build, managing advanced process simulations, and serving as the site's representative on global internal communities of practice.
As the site's Aseptic SME, you will oversee the continuous improvement of cleanroom operations and contamination control. Your core focus areas will include:
- Program Ownership: Lead the strategic development, execution, and deployment of the site's Environmental Monitoring (including EMPQ) and Media Simulation (Process Simulation) programs.
- Aseptic Qualification: Design and implement robust aseptic qualification and competency-building frameworks for manufacturing teams.
- Compliance & Audit Defense: Serve as the technical lead for aseptic and environmental queries during deviations and regulatory audits, ensuring flawless GMP compliance.
- Advanced Systems Management: Oversee and scale the site's Isolator Glove Management Program and contribute to standardizing cleanroom operations (garbing, sanitization, material/people flow).
- Cross-Functional Collaboration: Act as the manufacturing lead on the Sterile Council and Community of Practice (CoP), collaborating with QA, Engineering, Microbiology, and global network teams to align objectives.
Education & Experience:
- Degree: Bachelor's degree (or higher) in Science, Engineering, or a related technical discipline.
- Experience: A minimum of 5 years of operational experience within a sterile drug product manufacturing environment.
- Technical Expertise: Proven, hands-on experience with Grade A Isolator sterile filling processes and equipment.
- Simulation & Audits: Prior experience executing or coaching teams through Media Simulations, alongside a strong track record in GMP audit preparation and defense.
Key Skills:
- Excellent communication and presentation skills, with the ability to influence and collaborate across all levels of the organization.
- Strong analytical, systematic problem-solving, and decision-making capabilities.
- Superb organizational and planning skills to manage training programs and cleanroom support seamlessly.
