J4167WiltshirePharmaceutical Contract / Temporary / Interim£30.00 to £50.00 per hourFull Time20/07/2017Engineering
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We are currently looking for a Process Validation Engineer to join a leading Life Sciences company based in the Wiltshire area.
As the Process Validation Engineer you will be responsible for updating and executing Process Validation plans in a Pharmaceutical GMP environment.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Process Validation Engineer will be varied however the key duties and responsibilities are as follows:
1. Perform process validation activities to ensure cGMP requirements are met by implementing validation strategy and developing the Validation system lifecycle. This should include protocol compliation, execution, report generation and approval.
2. Develop process validation plans, protocols and reports by analysing, monitoring and generating statistical data and control charts as a part of Continued Process Verification (CPV).
3. Identify the user requirements (URS) in order to produce relevant process design documents (PID's, BOQ, FDS, DQ, IQ, OQ, VMPs etc) in line with Pharmaceutical regulatory requirements (EU GMP, FDA, MHRA).
4. Contribute to the Quality Improvement Program for the cleaning of legacy, process equipment.
To be successful in your application to this exciting opportunity as the Process Validation Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences or Chemistry Discipline.
2. Proven industry experience in validation within a Pharmaceutical or Biopharmaceutical manufacturing environment.
3. A working knowledge and practical experience with Process Validation to GMP standards and or/ GLP Quality System experience of the generation analysis, management & control of GxP documentation, data and records.
As the successful candidate you will have a thorough understanding of MHRA and FDA regulatory requirements for process and equipment validation.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.