Search Results: 30 vacancies
...CSV Engineer (Computer System Validation Engineer)
My client based in Dublin 15 is looking for a CSV Engineer (Computer System Validation Engineer) to join their team and someone who is responsible for validating and maintaining computerized systems to meet regulatory requirements...
...cyber security, quality, lifecycle management and regulatory requirements.
Key Responsibilities
Manage and coordinate the Lab System CSV deliverables for new and existing projects from initiation to release. Prioritising support activities in line with project schedules....
...Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices. Responsibilities...
...Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company.
Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk...
...software and configuration of software
Competency with larger volumes of data, spreadsheets, data manipulation, formula writing and CSV support
Technical knowledge of fundamental database concepts and relational data
Excellent written and verbal communication skills...
...direct supervision.
Experience of Pharmaceutical Industry Regulations cGMP/cGLP, 21 CFR 11 and EU Annex 11 compliance requirements.
Experience working with all disciplines in and supporting a Laboratory environment including QA, CSV, QC, Lab Analysts.
#J-18808-Ljbffr
...Requirements
Role Functions:
· Work with the manufacturing operations group,project design team, the CQV team, the Automation/CSV reps to facilitate thedevelopment and validation of the Biotech facility manufacturing facility.
· Support Equipment Design/ HAZOP...
...Conducting of informal and formal verification testing of the configured LIMS solution in collaboration with Computer Systems Validation (CSV) project resources.
• Generation of Test Scripts/Test Protocols for formal LIMS test execution as required.
• Supporting end users...
...learn, improve, and develop
Support addition of new equipment to the lab area
About you
Experience:
~3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
~ Experience in regulatory audits
Soft skills:
Excellent facilitation and...
...Assist in the development of software systems & policy compliance to regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
CSV experience to ensure compliance with GMP , and Data Integrity requirements on all systems.
Collaborate and support digital and data...
...new skills, protocols.
Attention to detail & a passion for troubleshooting
Knowledge of various formats including PCAP, XML, JSON, CSV, flat file
Good written and verbal communications skills with confidence in communicating technical details to a range of...
...Transformation in the Life Science Manufacturing domain in one or more of the following disciplines:
Computerized System Validation CSV
IT Infrastructure Network Qualifications
Laboratory Instruments/Equipment
Production/Manufacturing System
Manage SDLC (system...
...innovation to carry out the following:
Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the manufacturing facility.
Support Equipment Design/ HAZOP and Room...
...molecules.
Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV).
Additional Information:
Tasks may require repetitive motion and standing for long periods of time
Must be able to lift at...
Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liase with the IT and broader QA organizations to ensure all aspects of IT...
Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices.
Responsibilities...
...diagnosing technical issues in tasks such as:
Reading and understanding API documentation
Connecting to an FTP server
Reading CSV (comma-separated) files
Position Details:
Ability to dedicate 40 hours per week (significant overlap with 8-6 EST)
Strong technical...
Remote job
...this opportunity:
PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge based in these specialist areas from initial concept design through to commissioning and qualification...
..., bookkeeping, and commission reporting.
Key responsibilities:
#129534; Analyse data from external invoices in various formats (CSV, Excel, PDF) to evaluate rates, fees, and discounts of potential clients, enabling the sales team to offer competitive rates.
#1282...
Remote job
...Location – Ballydine , Ireland.
Primary & Secondary Skill
Validation Analyst / Computer System Validation (CSV)
JD (Detailed)
Preferred Skills:
• Minimum 3-5 years’ experience in the Pharmaceutical industry or a similar...