- Location: Cork
- Category:CSV Engineer
- Positions Available:1
OverviewKPC International currently require a CSV Engineer for a pharmaceutical site secondment in Cork. The successful candidate will provide IT compliance/validation support to the Automation & IT (A&IT) Team and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
• Prepare plans for remediation of legacy systems and implementation of new systems
• Deliver effective and efficient running of CSV Compliance operations in the A&IT team.
• Provide Compliance support, guidance and expertise
• Manage deployment of SDLC/CSV policies and procedures.
• Generation and execution of documents such as User Requirements Specifications, Design
Specifications, FAT, SAT, IQ, OQ, PQ etc.
• Review and approval of technical documentation from Vendors
• Qualification in an Electrical, Instrumentation or Control discipline with previous site-based experience
with 3 years’ experience.
• Thorough knowledge of GAMP 5, 21 CFR Part 11 also required
• A focus on lasting operational quality for the systems lifecycle
• Excellent communication / interpersonal skills.
• Enthusiastic and energetic with the ability to integrate quickly into a team environment.
• Demonstrated flexible and innovative approach to work
• Start: ASAP
• Contract Term: 12 Months
• Days Per Week: 5