Senior CSV Lead

Permanent
Dublin
 Senior CSV Engineer
Are you a competent CSV Engineer with a proven track record at a senior level and lead level?
Are you interested in joining a team that is building the future of regulated Cloud and Lifecycle Management services? This is an exciting and critical role within our Client who is rapidly expanding.
The Senior CSV Engineer will operate with the project teams in performing GxP Computerised Systems CSV activities. The role will be required across our Irish and international projects as part of our fast-paced, dynamic team.
This is an exciting opportunity to develop within a rapidly growing company and industry sector with future opportunities to shape the business models of the future!

Job Requirements
  • Management of client CSV activities and relationships
  • Working as part of client project teams to define CSV strategy for projects as directed by the CSV lead
  • Delivering front-end consultancy services as part of ongoing business development
  • Working as part of company and client teams in developing GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets, e.g. Lab, Automation, Business and Equipment systems.
  • Planning, coordination and participation in a compliant validation process for quality information technology systems requires formal validation documentation (FAT, SAT, IQ, OQ and PQ) under appropriate regulatory requirements and company manufacturing standards.
  • Investigate and troubleshoot problems, which occur and determine solutions or recommendations for changes and/or improvements.
  • Identify current and anticipated requirements for compliant computerised operations and suggest methods for identifying, implementing and maintaining the procedures, actions and documentation necessary to ensure compliance within the operation.
  • Implementation of policies and procedures to validate/qualify computerised systems.
  • Provide assistance where required with the preparation/execution of validation protocols and all associated documentation for GxP Computerised Systems, along with documenting and closing protocol defects.
  • Review/Approval of all GxP Computerised Systems Validation Documentation.
  • Administration of GAMP lifecycle across a project
  • Reporting status & project activities to the team lead
  • Any other duties which may be assigned from time to time
Qualifications
  • Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 10 years of relevant experience).
Experience
  • 5 to 8 years CSV Engineer experience within the Life Sciences industry
  • Experience with DeltaV/DCS/PCS validation
  • Experience in ASTM2500 is highly desirable
  • Prior experience in working with cGMPs and/or GLPs and Quality Systems
  • Data integrity projects (key focus is customer spec, VMP / Protocols / Reports)
  • Strong knowledge of data integrity
  • Strong knowledge of compliant SDLC based on GAMP 5
  • Thorough working knowledge of quality systems and regulatory guidance documents and standards.
Person Specification
  • Excellent communication and interpersonal skills.
  • Ability to communicate IT/Validation concepts/strategies to project teams.
  • Enthusiastic and energetic with the ability to integrate quickly into a team environment.
  • Be a self-starter and be motivated to provide a high-quality customer experience.
  • Demonstrated flexible and innovative approach to work.
  • Be adaptable to a fast pace working environment.
  • Be able to integrate and interact well within the customer environment.
  • Have excellent Microsoft Office user-level skills.