See All Jobs

IT / Software

Job Description

COMPUTER SYSTEMS VALIDATION CONTRACTOR required by CareerWise Recruitment for our BioTech client in Limerick. The COMPUTER SYSTEMS VALIDATION CONTRACTOR uses policies and procedures to validate/qualify computer enterprise systems, including process automation systems, IS applications/infrastructure and enterprise systems.

Role of this position

  • Prepares/reviews validation documentation related to projects/change controls.
  • Manages change controls and other compliance related tasks e.g. non-conformances.
  • Participates in the review of current and future CSV procedures and polices
  • Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with and guides other departments or outside contractors/vendors to complete validation tasks.
  • Supports regulatory audits and communicates company's computer validation policies.
  • Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps or Data Integrity.

JOB REQUIREMENTS

  • Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
  • Experience in a GMP environment essential.
  • Biologics experience highly desirable
  • Experience in Part 11 or Annex 11 or Data Integrity assessment completion
  • Experience in Enterprise validation highly desirable
  • Knowledge of Infrastructure qualification highly desirable
  • Knowledge of Cloud services qualification/validation.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Apply Now

IT / Software

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie