CSV engineer
- Ireland, Dublin
- Contract
- Compliance / Quality Assurance
One of the top 10 best companies to work in Ireland is looking for CSV engineer for their large-scale new facility in Dublin. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities include:
- Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for laboratory instruments and computer systems.
- Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
- Collaborate with cross-functional teams, including Quality Assurance, IT, and Laboratory Operations, to ensure successful validation and qualification activities.
- Maintain and update validation documentation, including validation master plans, standard operating procedures (SOPs), and validation summary reports.
- Conduct periodic reviews and requalification of laboratory instruments and computer systems to ensure continued compliance.
- Provide training and support to laboratory personnel on validation and qualification processes.
- Investigate and resolve validation-related issues and deviations.
- Stay current with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- Extensive experience in computer system validation and laboratory instrument qualification.
- Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry standards (e.g., GAMP 5).
- Experience with validation of laboratory instruments such as plate readers, liquid handlers, spectrophotometers, and other analytical equipment.
- Excellent documentation and technical writing skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills.
#LI-CO1
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
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
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
Save as job alert
Similar Jobs
Salary
Competitive
Location
Dublin
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Ireland
Dublin
Description
QC Analyst Material Management - Ireland, Dublin - 6-12 Months Contract One of the top 10 best companies to work in Ireland is looking for QC Analyst Material Management for their large-scale
Reference
36959
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonSalary
Competitive
Location
Paris
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
France
Description
CQV Engineer - France, Paris - 6-12 Months Contract Our client, a global pharmaceutical company, are looking for a CQV Engineer to join their team. The company has grown to become a world
Reference
36956
Expiry Date
01/01/0001
Author
Caroline O’SullivanAuthor
Caroline O’SullivanSalary
Competitive
Location
Dublin
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Ireland
Dublin
Description
QA Senior Specialist Compliance - Ireland, Dublin - 6 Months Contract One of the top 10 best companies to work in Ireland is looking for a QA Senior Specialist Compliance for their large-scale new
Reference
37715
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Caroline
I manage this role.