Commissioning &Amp; Qualification Engineer - Lyophilisers (Freeze Dryers)

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

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Pharmaceutical / Medical Device client based in the Middle East have an 8 month contract requirement for an experienced C&Q Engineer with good experience of Lyophilisers.

Working on the upgrade of a new manufacturing line with new autoclaves & freeze driers you will be required to generate and review the SAT`s, FAT`s, C&Q work and create the protocols

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
- Maintaining cGMP & GDP standards in protocol generation and execution
- Performing all tasks as per Protocol / SOP
- Willing to work shift/flexible hours to maintain schedule

-First Level Degree (or equivalent)
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
-Min 8 years C&Q experience
-Cleanroom work experience - Grade A-D (ISO 4.8 - ISO 9)
-Equipment commissioning/qualification execution experience essential inLyophilizer
-Experience of working with Construction Contractors and Vendors and experience of compilation and review of Construction turnover IQ support binders an advantage
-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.

This contract will include:

- Accommodation paid for
- Cost of Flights reimbursed by client
- Per diem for every day spent - even weekends
- Transport to and from work 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)