CQV Engineer
- Ireland, West
- Contract
- CAPEX Projects
We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Ireland. Due to a large capital investment and multiple projects on site, the client is looking for a CQV Engineer to join their team.
Responsibilities include:
- CQV documentation – drafting, reviewing and approving CQV documentation
- Oversight of the Commissioning, Qualification, Validation of specific equipment, ensuring all projects are on schedule and meet the set time-lines.
- Provide guidance / expertise in one or more of the following equipment / areas : Clean Utilities, HVAC, Media Preparation, Buffer Preparation, Process Equipment, QC Equipment and instruments.
- Support ongoing HVAC re-qualification and new facility qualification
- Oversee the start-up and commissioning of new equipment within the Packaging, BDS and Warehouse areas.
- Experience in System Start up, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
- Accountable for ensuring activities are scheduled, tracked, and reported appropriately, and achieving project deadlines.
- Support the ongoing site re-qualification program
- Risk assessments, root cause analysis and investigations.
- Review of protocols, reports, project change controls and deviations.
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- Generation and review of protocols, reports, project change controls and deviations.
- Commissioning, qualification and validation experience in Pharma or Biopharma Manufacturing Facility
- Relevant experience as subject matter expert / engineer in a high-tech industry such as Biotech or Pharma, preferable
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
- Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
- Experience in HVAC qualification/re-qualification desirable.
- Excellent technical abilities with a solid base in engineering.
- Strong technical writing and communication skills.
- Proven track record in generation of validation/verification documentation.
- Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
#LI-J
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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