Description
VALIDATION ENGINEER - Immediate Start - Ireland, Cork - €50 - €60 per hour, EngineeringMy client is a global leader in the pharmaceutical industry with offices in Ireland, the United States and Puerto Rico, and servicing the Life Sciences, F&B and Utilities industries. They are seeking a Validation Engineer with at least 3 - 5 years' experience for a 12 month rolling contract in their Cork office, Ireland. You will be responsible for the development and execution of CSV and C&Q deliverables for systems, including automation systems within Biopharmaceutical production facilities.
Key Responsibilities:
- Development and execution of C&Q and CSV protocols for manufacturing production systems throughout the system development life cycle such as Risk Assessments, Validation/Qualification Plans, User/Functional Requirements, Design Qualification (DQ), FAT/SAT, Testing (IQ/OQ/PQ), Traceability Matrix and Final Reporting on both, Legacy systems as remediation efforts and new systems.
- Execution of gap assessments and remediation initiatives regarding data integrity for computerized systems within the site, including laboratory as well as production systems.
- Understanding and experience with regulations for Computer System Validation and Commissioning and Qualification such as FDA cGMP's for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ICH 9, ASTM E2500, GAMP5, ISPE C&Q Guidelines 5, 12.
- Familiarity and exposure with control systems including Delta V, Foxboro, Siemens S7/PCS7 and Rockwell PLC's, iFIX and Wonderware SCADA system.
Requirements:
- From three 3-5 years of related work experience with strong knowledge and hands-on experience of C&Q and CSV activities in the regulated industries.
- Knowledge and experience of API, Bulk Chemicals, Fill Finish, Parenterals, and/or Dry Products processes and technologies.
- Experience with development of Risk Assessments, URS, FRS's, DDS, DQ, Validation and Test Planning, Development and Execution Commissioning and Qualification protocols.
- Strong analytical, problem-solving and interpersonal skills
- Deals well with uncertainty, pressure and accountability
- Fully fluent in English and Microsoft Essentials
My client is looking for somebody for an immediate start - if you would like to be considered for this role or hear more about this opportunity, please contact me/send your CV by Tuesday 20th November 2018 to (see below) or call me