Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Conduct toxicology evaluations, and manage equipment train data collection
- Manage and oversee Hold Time Studies, including protocol development and execution for buffers, process intermediates, and new assemblies (CHT, SHT).
- Oversee Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) qualification for various equipment such as feed vessels, fermenters, grinder break tanks, and CRVs, including bioburden and endotoxin risk assessments (Buffer, Media, and Product)
- Perform assessments for Extractables & Leachables (E&L) and Cleaning Confirmation (CC), including the evaluation of worst-case soils and cleaning validation.
- Ensure the proper qualification of autoclave loads and decontamination processes
- Assess all major deviations for impact on product quality, including risk assessments for various equipment and homogenization processes.
- Develop and execute validation protocols, including those for CIP, SIP, Autoclave Qualification, and Decontamination Autoclave protocols.
- Take ownership of subsequent Corrective and Preventive Actions (CAPA) and ensure compliance with regulatory standards.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 5 – 10 years’ experience in Engineering, pharmaceutical industry
- Demonstrated skill and knowledge with equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
- Equipment and process troubleshooting skills
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
- Experience with product/process development and project management is a plus.
- Lean Sigma/ Green Belt certification is a plus.
- Continuous improvement mindset
- Adherence to safety protocols and global regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
