CSV Engineer Lead

at  SL Controls Ltd

SKILLS BRIEF:

• Experience of GxP Computerised Systems
• Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
• Familiar with the GAMP5 guidelines.
• Experience with serialization & Systech Technology
• Excellent understanding of validation concepts and documentation.
• Expected to be on site during the project with the exception of attendance at any FAT

THE ROLE:

• CSV Engineer Lead
• Onsite, Sligo
• Permanent/Contractor

ROLE BRIEF:

As our Lead CSV Engineer you will be working on generating validation docs, collaborating with the global validation team and co-ordinating executions along with the automation team members.

RESPONSIBILITIES:

• Managing and co-ordinating the preparation, review and approval of the Validation Master Plans
• Managing and co-ordinating of all validation strategies and deliverables
• Development and maintenance of internal validation policies and procedures based on best international standards and practices
• Auditing of internal projects against internal validation policies and procedures
• Managing and co-ordinating the preparation, review and issuing of validation protocols and reports
• Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports.
• Managing and co-ordinating the review and approval of specifications associated with Equipment, Processes, Products and Computerised Systems.
• Managing, co-ordinating and directing all validation and revalidation activities.
• Reviewing, managing and approving change control forms for Validation/Compliance implications.
• Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
• Updating existing quality documentation related to validation activities.
• Identifying training requirements for project team members in support of validation.
• Managing and co-ordinating risk assessments for customer projects.
• Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device.
• Provide technical direction in the development and review of software requirements.
• Managing and co-ordinating the design and implementation of software validation processes on projects.
• Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process.
• Provide technical direction and hands-on assistance for testing projects.
• Reviewing vendor validation documentation
• Managing and co-ordinating all project validation activities (including the vendors)
• Motivates & coaches team to enhance performance.
• Work closely with the commercial department to assist in opening new client opportunities and generation of client proposals
• Makes articulate and effective presentation to a variety of audiences, large or small, internal or external.
• Effectively communicates and constructively defends results of own work or teams’ work at technical presentations in-house, with clients, and at technical meetings
• Liaising with customer department
• Addressing customer feedback and providing progress updates to customers