Description
A leading Pharmaceutical organisation based in the North West of England are seeking 2 Equipment Qualification/Validation Engineers to work on 6-8 months contracts, starting ASAP.Rates are open Dependent on candidates experience & will be discussed over the phone following your CV submission.
The two roles require similar experience, one role is todefine and implement the qualification strategy & maintain the validated status of facilities, utilities, equipment and processes & the other role is to support OQ gap analysis & PQ execution for a new suite & would be assigned to PQ activities for various systems including WFI & Air Flow.
Some of the responsibilities include:
- Define and execute the validation strategy associated with site projects covering a range of a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations.
- Define the validation testing strategy for requalification/revalidation activities
- Identification and implementation of continuous improvement initiatives to ensure lean ways of working.
- Drive a risk based validation life cycle utilising quality risk management principles and tools (eg FMEA, HAZOP)
- Investigation and compliant resolution of non-conformances encountered
- Review proposed Change Controls to assess the impact on the validated status
- Generation and maintenance of Validation Plans and Validation Master Plans
- Carrying out OQ gap analysis
- Executing PQ
- Ideally Degree educated in relevant life sciences or engineering discipline
- 5+ years hands on equipment qualification experience (greatly advantageous to have experience in an aseptic manufacturing environment)
- Significant Pharmaceutical experience (medical device experience will be considered)
- Understanding of aseptic processes and associated process equipment
- Understanding of quality risk assessment principles
- Advantageous to have experience presenting during FDA/MHRA audits
- Experience in OQ, PQ activities including gap analysis (advantageous to have experience doing this for WFI & air flow systems but not required)
Please pass this opportunity on to others who may be interested as we offer a referral reward.