Description
Pharmaceutical/Medical Device client based in the Middle East have an URGENT requirement for an experienced C&Q Engineer with excellent AUTOCLAVE experience.You will be required to carry out the SAT/ FAT, IQ & OQ of the new Autoclaves.
Responsibilities will include:-
- 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
- Investigation and resolution of protocol discrepancies and punch list items
- Maintaining cGMP & GDP standards in protocol generation and execution
- Performing all tasks as per Protocol / SOP
Education:
- First Level Degree (or equivalent)
Work Requirements:
- Work experience in a cGMP Facility preferably Pharmaceutical / Biotech / sterile manufacturing
- Min 8 years C&Q experience
- Cleanroom work experience - Grade A-D (ISO 4.8 - ISO 9)
- Equipment commissioning/qualification execution experience essential in:
o Autoclaves
o Temperature Mapping: Preparation, execution, analysis and report
o Clean utilities
- Experience of working with Construction Contractors and Vendors and experience of compilation and review of Construction turnover IQ support binders an advantage
- Experience of using manufacturing control systems such as SCADA systems or related automation systems as part of commissioning and qualification tasks essential
- The Commission & Qualification 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.
- Track record on documentation generation and execution
- Proven ability to deliver to tight deadlines within a project environment and be accountable for same
COSTS:-
Accommodation paid for
-Cost of Flights reimbursed by client
-Per diem for every day spent in Israel - even weekend
-Transport to and from work in Israel (either taxi`s or use of a pool/hire car minimum of one car between two)
-Use of mobile phone for project use
-Client organises and pays for work Visa
-Quanta has a payroll solution in place (split payroll)
-6 weeks on one week off (to be at home)
Call me today for further details.