Data Integrity Engineer – Mayo

  • Reference: GY46417
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

Job requirements:

  • Excellent opportunity for individual development across systems, equipment and production processes with an industry leading, highly automated, fast moving Pharmaceutical team.
  • With the current team, support the business unit data Integrity enhancements for process automation systems.
  • Complete data Integrity reviews and subsequent remediation activities of business units systems and processes.
  • Generate data process 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.
  • Lead and/or assist the development of critical alarm matrix for systems which will be lead into procedural controls.
  • Develop training modules to continue the upskill and awareness of data integrity across the business unit.
  • Develop matrix of the systems access levels across users, set ups, administrators and engineers.
  • Oversee the data integrity compliance of new installs and upgrades to meet Annex 11 and 21CFR Part 11
  • Updating of the current system risk assessments and risk mitigation plans. Completion of risk assessments for new installs.
  • Support system administrators in the effective audit trial reviews.

Skills, Experience and Qualifications required for this position:

  • Third level qualification in Engineering / Science.
  • Experience: +3 years working in a regulated environment.
  • Solution focused, with in-depth technical knowledge of both procedural controls and system controls for managing data Integrity.
  • Must be motivated and passionate about production systems.
  • Excellent documentation, organisational and prioritisation skills.
  • Ability to organize work load and work on own initiative.
  • Ability to effectively communicate plans, proposals, and actions at management levels.
  • Demonstrated problem solving skills.
  • Experience in a highly automated manufacturing desirable

Desirable:

  • Qualification in computer science/automation/mechatronic engineering.
  • Knowledge of the GAMP guidelines applicable to computer system validation.
  • Experience supporting Siemens, Allen Bradley, PLC, SCADA and HMI systems in a manufacturing environment.
  • Knowledge of regulatory requirements in a pharmaceutical GxP environment.
  • A strong understanding of current data integrity expectations would be a distinct advantage. 
  • Strong knowledge of Annex 11 and 21CFR Part 11

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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