The role:
PE Global is currently recruiting for a CQV Engineer on behalf of our client based in Dublin. This is an initial 12-month contract role.
Responsibilities:
- Act as Quality Assurance approver for qualification/validation lifecycle documents.
- Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
- Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads
- Provide Quality Assurance Validation support for the Cleaning Validation Program.
- Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
Education and Experience:
- Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline
- This role requires a minimum of 3 years’ experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
- Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
- Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
- Technical knowledge of cleaning validation/verification, quality systems and regulatory requirements.
- Experience in review and approval of Cleaning Validation studies.
- Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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