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Job Title: CSV (Data Integrity) Engineer – Cork based role (JO917) – Cork Site

Job Desc: Zenith Technologies are looking to hire a CSV (Data Integrity) Engineer based on a customer site in Cork.

Location: Cork, Ireland

Role

CSV (Data Integrity) Engineer – Cork based role – Cork Site

Business Unit ZT Site Services
Location of Position Cork, Ireland
Start Date Jan 2017
Project Cork based role
Platform(s) Siemens PLC
Historian OSI PI

Role/s
Zenith Technologies are looking to hire a CSV (Data Integrity) Engineer based on a customer site in Cork in a Data Integrity Role. The Computerized System Validation (Data Integrity) Engineer will be a key member of the clients Execution Systems team.

The successful candidate will be responsible for supporting the site’s Data Integrity initiative by assisting in the development of Data Integrity policies and SOPs in line with Industry guidance; performing Gap Analysis on the existing electronic and paper systems; working with cross functional teams to develop action plans to address gaps and track completion.
This is an excellent role and an important position as part of this Clients Execution Systems Team.

Qualifications, Experience / Skills:

  • A BSc/BEng/BA Degree or equivalent experience with advanced degree
  • Experience working within a regulated environment
  • 3+ years Computer Systems Validation experience
  • Strong problem solving skills and an ability to analyze scenarios to develop the most appropriate solution are required
  • Excellent communication and interpersonal skills are essential
  • Excellent organizational and prioritization skills
  • Strong documentation skills
  • Ability to work well under pressure, multi-task and meet deadlines
  • Ability to work well both independently and in a team environment
  • Ability and flexibility to perform all other job-related and ad-hoc duties as required
  • Attention to detail, flexible/adaptable, good communication, GDP, ability to work on own initiative
  • Technical understanding of automation systems (Siemens PLCs)
  • Technical understanding of OSI PI Historian.
  • Strong knowledge of Annex 11 and 21CFR Part 11
  • Completion of certified data integrity training is desirable

Main Responsibilities / Duties:

• Complete Data Integrity reviews and subsequent remediation activities of site control systems and processes
• Generate data maps to describe the data flows throughout the systems and to identify critical data control points/transactions
• Identify data integrity gaps and propose solutions
• Lead and/or assist with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps
• Compliance and adherence to all the relevant company policies, industry standards and regulatory expectations

*Further details on role available to short listed candidates.

To Apply

Apply through this link or send your CV referencing job order – JO917 to jillian.barry@zenithtechnologies.com or call Jillian Barry in confidence +353 21 4370279. You can also link in https://ie.linkedin.com/in/jillianbarry1

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Jillian Barry

jillian.barry@zenithtechnologies.com

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