Design, implement, and validate new aseptic production lines and GMP-compliant cleanroom facilities, aligned with international and local regulations.

Develop and optimise aseptic formulation and filling processes for new health or skincare-related products.

Establish robust protocols for aseptic operation, including clean-in-place (CIP), sterilisation-in-place (SIP), and contamination control.

Draft and execute process and equipment validation protocols, including aseptic process simulations (media fills).

Ensure full compliance with TGA, PIC/S, and international GMP standards across all aseptic operations.

Oversee training of cleanroom personnel in aseptic techniques and environmental behaviour standards.

Manage quality-related activities, including CAPA, deviation investigations, and change control in aseptic environments.

Collaborate with QA, R&D, engineering, and manufacturing teams for smooth tech transfer and scale-up of aseptic processes.

Contribute to asset management, budgeting, and cost control related to aseptic facility setup and operation.

Qualifications and Experience

Bachelor’s degree or higher in Chemical Engineering, Pharmaceutical Engineering, Bioprocess Engineering, or a related field.

At least 1 year of direct experience in aseptic process development and manufacturing under GMP conditions, ideally in vaccines, injectables, or health-related products.

Proven knowledge of ISO cleanroom classifications, TGA regulations, GMP validation requirements, and aseptic handling protocols.

Demonstrated skills in aseptic system troubleshooting, optimisation, and cross-departmental coordination.

Proficiency in Mandarin and familiarity with Chinese regulatory systems is highly desirable, as China is one of Careline’s largest export and consumer markets