Operator for new filling line project (Osaka Plant)
On-site · Osaka, Osaka, Japan
Job Summary
The role involves executing liquid and powder filling, sterilization, and validation of cleaning machinery for a new filling line project. Responsibilities include daily collaboration with manufacturing, engineering, quality control, and quality assurance departments to prepare for commercial production. Key qualifications include practical experience in GMP operations, particularly with sterile filling processes, and proficiency in documentation for equipment validation and inspections. Strong interpersonal and leadership skills are essential for project management and decision-making within a team.
Required Qualifications
- Technical/professional expertise in preparation and execution of protocols and SOPs related to drug/biotechnology validation.
- Basic understanding of cGMP regulatory environment and the ability to work under such norms.
Desired Qualifications
- Experience in pharmaceutical manufacturing, particularly in sterile filling processes using isolators.
- Knowledge of equipment and process design and validation.
Additional Requirements
- Ability to work in a controlled environment requiring special gowns and protective clothing.
- Must be able to perform the job while following safety procedures for handling chemicals that require respiratory protection.
- Availability for multiple shift work, including weekends and overtime as required.
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