Job Description
Our client, a Biotech company based in Dublin, now seek a QA Validation Senior Engineer who will oversee all Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment systems on site, along with equipment re-qualification requirements.
This is a high-level, permanent role in Dublin with strong salary and benefits package.
The successful candidate will oversee vendors / contractors on site during commissioning activities. Additionally, this hire will provide CQV support to locally managed capital projects that are performed on site.
The ideal candidate will have 5+ years CQV Engineer experience in Pharma or Biopharma cGMP manufacturing facility, ensuring Quality Assurance compliance with regulations including HPRA, EMA and FDA.
Responsibilities for QA Validation Senior Engineer:
Manage ongoing equipment re-qualification and periodic review requirements.
Develop and deliver annual equipment re-qualification requirements.
Provide CAPEX team with validation support.
Review vendor documents to support commissioning and qualification requirements.
Complete the review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
Ensure validation non-conformances or deviations are minimised during execution of CQV activities.
Ensure compliance with current industry regulations relating to qualification and validation.
Support the Technology Transfer plans for incoming new products.
Provide support during preparation for and participation in regulatory inspections
Provide support during implementation of Engineering changes to non-GMP systems and equipment
Requirements for QA Validation Senior Engineer:
Third level qualifications in Engineering or Science Degree, or equivalent
Experience with regulatory audits, in particular representing facility equipment qualification type issues.
5+ years validation experience (CQV) within a pharmaceutical manufacturing facility.
Proven experience of validation activities and regulatory guidelines for a pharmaceutical facility.
Experience writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
Please contact Larry on +353 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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