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CSV Engineer

Job in Ireland
Full Time position
Listed on 2020-03-08
Job specializations:
  • Science
    Biotech Clinical Research
  • Pharmaceutical
    Pharmaceutical Manufacturing, Pharmaceutical QA, Pharmaceutical Sciences
Job Description & How to Apply Below
CSV Engineer
Location:   Dublin ( International Travel Required 10-30%)



DESCRIPTION
RecruitNet are currently looking for a CSV Engineer for a leading Biotechnology client based in Dublin.

Duties and Responsibilities:
Project and Computer System Validation lifecycle
Development of protocols for software testing
Understanding and background in working with MES, Historian & ERP systems would be very advantageous
History of regulated industry (Life Science / Pharma)
Understanding of Industry best practices (GMP,GAMP, cGMP, cGDP), 21 CFR Part 820,11, ISO13485
Project Management
Process validation protocol (IQs, OQs, PQs)
Position Requirements
Bachelor,   1 to 2 Years work experience
Experience:
+3 years' experience in a GMP regulated environment, with exhibited knowledge or proficiency of industry standards for computer system design, implementation, and validation.
Practical understanding of GAMP 5, 21 CFR Part 11, EU Annex 11.
Experience in pharmaceutical / biotech / medical device industry.
Strong experience in Process Automation Systems.
Knowledge of Laboratory Information Management System (LIMS).
Strong communication and presentation skills.
Working knowledge of Project Management and system implementations/integrations.
Familiarity with computer infrastructure, servers, workstations and operating systems.
Clear understanding of data integrity issues associated with CSV systems.
Should work on IS compliance strategy
Implementation of processes and procedures related compliances  
Develop validation plans iq oq pq support
Assure all validation test procedures are in line with current corporate and government regulations


Qualifications and Requirements :

Bachelor's degree required in Engineering (Chemical, Computer, Mechanical or Electrical), or Computer Systems.
Strong knowledge of Computerized Systems validation and compliance regulations and standards.
Experience on Automation Compliance projects including but not limited to PLC's, HMI's, DCS, Historians, Industrial Data Networks, Instrumentation and related systems (hardware / software).
Knowledge of GMP, OSHA, FDA, and environmental regulations applicable to the Pharmaceutical Industry.
Should have work Permit in Ireland or EU WORK permit

To apply for this job, please submit your CV to Renji at (Please contact us using the "Apply for this Job Posting" box below),
Required Language Skills:
  • English - Very good
Additional Information / Benefits
Salary Range:   Euro. 60,000/- - 70,000/- Per annum plus Benefits
Questions to answer on applying for this job
  • Do you have Work Permit in Ireland?
  • Do you have 3 Plus years exp. as CSV Engineer in Biotech/Pharma or Life-science?
  • Notice Period
Contact Information
Contact Name: RecruitNet International Ltd.
Contact Phone: +353894048431
Preferred method of contact: Email with CV via Application Box below.
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