Commissioning And Qualification Engineer

Job type:
Start date:
Quanta Consultancy Services
Published at:
flag_no United Kingdom
Contact person:
Lee Mitchell
Project ID:

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Excellent new opportunity for an experienced Commissioning and Qualification Engineer with excellent Autoclave OR Lyophilizers (Freeze Dryers) experience, to work for a Global Bio Pharma /Medical Device client based at their facility in the Middle East.

Responsibilities will include
-Carry out the SAT/ FAT, IQ & OQ of the new Autoclaves OR Lyophilizers
-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 / Spread sheets
-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

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: Autoclaves OR Lyophilizers
-Temperature Mapping: Preparation, execution, analysis and report
-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

Excellent long term opportunity offering competitive rates and exceptional benefits package.