CSV Engineer

PE Global is currently recruiting for a CSV Engineer for our biopharmaceutical client in Limerick. This is an initial 12-month contract, hybrid role.

Duties and Responsibilities

Generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments e.g. Part11 Assessments, etc. related to IT Infrastructure systems and related IT Applications and system components
Prepares/reviews validation documentation related to projects/change controls.
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 other departments or outside contractors/vendors to complete validation tasks.
Participates in regulatory audits and communicates company’s computer validation policies.
Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.

Education and Experience

Requires BS/BA in Engineering, Chemistry, or Life Sciences with 2+ 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***