CSV Engineer
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
If so, this could be your chance!
One of our global pharmaceutical clients is looking for a CSV Engineer to join their team at their new large-scale Bulk Drug Substance facility.
This is a fantastic long term contract opportunity to be part of a fast-paced, €700 million project; working with and learning about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
CSV Engineer
Duties
• Generates, revises and executes CSV documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Works with Manufacturing (MFG), Engineering (ENG), Facilities (FAC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities. Manages or supports the CSV plan supporting overall project timelines and site objectives.
• Partners with Quality Assurance IT (QAIT) to ensure policies and procedures reflect up to date regulatory expectations for CSV.
• Responsible for leading or participating in risk assessments associated with CSV activities.
• Generates, revises and/or reviews plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV.
• Responsible for providing input, as required, for design documentation to ensure system life cycle for automation of new and upgrades to existing production equipment.
• Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment, as related to CSV.
• Resolve CAPA's, nonconformances, protocol incidents, and change controls related to CSV protocols.
• Serves as a computer system validation subject matter expert for client and regulatory audits.
• Responsible for attending client meetings as an Engineering representative for purposes of addressing CSV.
For further information or to apply, get in touch today!
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I have always received a highly professional & personable service from the team at Quanta. 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
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
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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