Description
Pharmaceutical / Medical device client has an URGENT requirement for an experienced ommissioning & Qualification Engineer to work on site based in the Middle East.You will be required to carry out the C&Q of the new Autoclaves within an aseptic fill finish line.
You will be required to carry out the following:-
Responsibilities:
-Review FAT / SAT / IQ & OQ Documentation
-Develop Engineering Equipment Files
-Generate FAT / SAT / Commissioning / IQ / OQ & PQ Documentation
-Execute Commissioning / IQ / OQ & PQ Protocols
-Set up / calibration of test equipment
-Preparation of test datasheets / configuration loads
-Review of Datasheets
-Data input on to Datasheets / Spreadsheets
-Analysis / trending and Filing of Data
-Generation of reports
-Maintaining cGMP & GDP standards in protocol generation and execution
-Performing all tasks as per Protocol / SOP
Skill requirements:
-Proficient written & oral capability in English language
-Excellent time management - work to a schedule
-Excellent documentation skills in English
-Good time keeping
-Good communication skills in English
-Ability to troubleshoot and problem solve
Work Requirements:
-Work experience in a cGMP Facility preferably Pharmaceutical / Biotech / sterile manufacturing
-Good Autoclave C&Q experience
-Cleanroom work experience - Grade A-D (ISO 4.8 - ISO 9)
-Equipment commissioning/qualification execution experience essential in:
oAutoclave
oTemperature Mapping: Preparation, execution, analysis and report
oFill/finish CIP/SIP experience
The C&Q Engineer must be able to work on own initiative and within a team environment and be self motivated and a driven individual in order to work thru construction turnover related issues and manage/co-ensure punch close out task closures for discreet projects.
- The client will reimburse for flights
- Accommodation paid for
- Shift : 6 weeks on one week off
- 45 hour working week
- Transport to and from work
- Per diem per day