CSV Engineer
Paciv
Cork
PACIV, a global leader in industrial automation solutions with offices. in Puerto Rico, United States and Ireland, and servicing the Life Sciences, F&B and Utilities industries, is looking for regular employment-based. Automation Validation Engineer 5+ years’ experience for its Customer site in the Munster area. Job Description: The Validation Engineer will be responsible for the development and. execution of CSV and C&Q deliverables for systems, including automation. systems within Biopharmaceutical production facilities. This consists of. Validation Planning, User/Functional Requirements, Design Specifications, Design Qualification (DQ), Testing protocols development and execution. (software and hardware) and Final Reporting. Position Responsibilities/Essential. Functions · 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 and 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 · Education: Bachelor’s degree in engineering or. related science studies. Work Experience: · Five (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. Desired Hard Skill Sets: · Development and execution of C&Q and CSV deliverables for. system-development life cycle of industrial automated systems. · Proficient knowledge of C&Q and CSV system life cycle concepts and EMA. and FDA regulatory requirements, including FDA cGMP’s for the 21st Century, 21. CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based. Approach, ISPE C&Q Guidelines 5, 12, ICH 9, ASTM E2500, GAMP5 · Experience with development of Risk Assessments, URS, FRS’s, DDS, DQ, Validation and Test Planning, Development and Execution Commissioning and. Qualification protocols. · Project management skills Desired Soft. Skills: · Automation systems background · Strong analytical and problem-solving skills. · Deals well with uncertainty and pressure. · Works well with others, within a team and takes accountability. · Result driven and self-motivated. · Strong interpersonal and communication skills (verbal and presentation). · Organized, with strong computer literacy such as MS Project, Excel, etc. · Fully fluent in English. Other Requirements · Location: Cork, Ireland Must have a VALID EU WORK PERMIT or IRISH RESIDENCY. .
1196 days ago