Computer System Validation Engineer

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Job Summary: The Computer Systems Validation Engineer position is responsible for authoring, executing, reviewing, and reporting on validation-related deliverables in compliance with applicable regulations and company policies and procedures. Essential Functions: Develop, execute, and review complete sets of system qualification project deliverables including but not limited to requirements, plans, assessments (vendor, compliance, risk, etc.), specifications, development testing, protocols (e.g., IQ / OQ / PQ), reports, analyze test data, generate test issues, and verify test protocol execution/reports. Assist in the developing / review of SOPs for user operation, system administration and maintenance, back-up / recovery, and audit trail review, or other supporting process control topics within the SDLC. Contribute as needed in the creation, execution, and closure of QMS processes including but not limited to Change Control Projects, Deviations, CAPAs, and Quality Events. Contribute as needed in system periodic reviews. Assist in the support of audits by gathering and preparing evidence. Other duties as assigned. Necessary Skills and Abilities: Demonstrate qualified working knowledge of all applicable consensus standard and regulatory requirements as they relate to CSV and data integrity including but not limited to the following: 21 CFR Part 11, Annex 11, ICH (E6, E9, Q9), ISO 27001 / 27002. Demonstrate qualified working knowledge of all applicable current industry best practice guide approaches as they relate to CSV and data integrity including but not limited to the following: FDA (CSA, DI, General Principles of Software Validation), GAMP (DI, GCP CSV, IT Infrastructure, Risk-based CSV, and Operation). Demonstrate qualified working knowledge of the layers of information technology / network architecture as they relate to systems and business processes (e.g., network environment, server hardware, operating systems, databases, applications, clients (endpoints); as they associate with the OSI Model and ANSI/ISA-95. Demonstrate qualified working knowledge of the layers of the SaaS technology stack paradigm including but not limited to IaaS, PaaS, and SaaS, their applicable components, and interrelatedness associated with a…