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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
GMP
GMP* HEPA
As one of the worlds largest manufacturers of packaging and inspection machines for pharmaceutical manufacturing you will be responsible for the validation of automated machines such as pharmaceutical cleaning sterilization and filling machines mainly our injectable filling lines.
During validation you will check whether the machines comply with GMP a regulation for ensuring drug safety. The main tasks are as follows.
1) Installation qualification inspection which checks whether the installed machines meet the design specifications. (Check important parts check piping gradients etc.)
2) Calibration checking whether instrumentation equipment such as target temperature sensors are within the compliance standards.
3) Operation qualification inspection: Actually operate the machines checked in 1) and 2) to check whether they comply with GMP regulations. (*Main inspections: Washing machine: Check cleaning function; Tunnel sterilizer: Check air speed HEPA* filter leaks cleanliness temperature distribution; Filling machine: Check filling accuracy.
*Each inspection uses the necessary measuring equipment (calibrated and traceable to national standards).
*Documents for inspections 1) 2) and 3) are created and the inspections are carried out in accordance with the created documents.
Qualifications :
3
TOEIC 500
PLCPCOSLAN
GMP
Graduate from a technical college or university: Mechanical engineering (basic knowledge of electricity machinery mathematics and physics)
Experience in field engineering at a manufacturing company: 3 years or more
Able to work on business trips within Japan
High mobility teamwork and communication skills
Native in Japanese language TOEIC score of 500 or higher (no problem with reading and understanding English emails and texts)
Knowledge of measuring instruments
Knowledge of machine control: programming PLC PC OS LAN
Knowledge of GMP (Good Manufacturing Practices)
Qualification as an electrician
:
1464-410
8:4517:3012:1513:008
2128
1
2
1
TOEIC
Work location
Competence Center Japan and Vision Technology Office
1464-4 Tsukinowa Namekawa-cho Hiki-gun Saitama Prefecture (nearest station: 10-minute walk from Tsukinowa Station on the Tobu Tojo Line)
Working hours
8:45-17:30 (break 12:15-13:00) 8-hour work schedule
Flextime and telecommuting systems available
Salary
Pay will be based on experience and ability
Holidays
2 days off per week (Saturday and Sunday) public holidays New Years holidays summer holidays *128 company holidays per year
Annual paid leave paid sick leave
Benefits
Salary increase once a year
Bonus twice a year (summer winter)
Performance bonus system (paid once a year only when performance targets are achieved)
Full social insurance (health insurance employee pension insurance employment insurance workers accident compensation insurance)
Full transportation expenses paid
Retirement benefits system (defined benefit pension system defined contribution pension system)
Welfare club
Training system
Self-development program support (subsidy for English training and TOEIC exam fees)
In-house open seminars etc.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
