CSV Engineer

CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose informs everything we do: • We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At CAI, we are committed to living our Foundational Principles, both professionally and personally: • We act with integrity • We serve each other • We serve society • We work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. Requirements include: Position Description: We are now seeking CSV Engineers to join our growing operations in Australia. The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include: • Prepares/reviews validation documentation related to projects/change controls. • Manages change controls and other compliance related tasks e.g., non-conformances. • Participates in the review of current and future CSV procedures and polices • Analyses the results of testing and determines the acceptability of results against predetermined criteria. • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation. • Coordinates with other departments or outside contractors/vendors to complete validation tasks. • Participates in regulatory audits and communicates company’s computer validation policies. • Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps. • Manages projects and prepares status reports using Microsoft project and other communication tools. • May supervise, lead, or manage lower-level personnel. Position Requirements: BS in a Computer Science or Engineering field or equivalent experience Minimum 2-7 years’ experience with Computer systems validation. Minimum 2-7 years' experience working in a GMP environment. Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience highly desired Experience in biotech and pharma is preferred over medical device. Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc. Other Requirements: Excelle