Computer Systems Validation Engineer (CSV)

Position : CSV Engineer Location : Sunnyvale CaliforniaDuration : 3 MonthsComments:Candidates with experience in Enterprise Business Application Validation process in a medical device company preferredJD:Computer Systems Validation EngineerDuties / Expectations of Role• Maintains responsibilities for ensuring GxP computerized systems operate within the frameworkof regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined inlocal procedures.• Provide direct oversight for computer system validation from a quality assurance perspective toensure quality and compliance requirements are met.• Provide guidance on CSV validation issues and discrepancies. Support investigation of CSVdefects and quality records (deviation, CAPAs).• Review CSV Validation activities including deliverables from regulatory compliance standpoint.• Provide support to external and internal audits related to computerized system validationactivities.• Advice a cross functional team in an efficient manner, including but not limited to excellentcommunication and time management skills to share responsibilities and expectations, andaccomplishing goals throughout timelines.• Help, establish and sustain computer system validation global policies and standards thatincorporate industry best practices and are health authority compliant.• Partnering with internal and external teams; sharing information to increase the collectiveunderstanding of QA and Compliance programs.• Solid knowledge of industry standards related to computerized systems and ElectronicRecords/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.• Ensuring alignment of processes, procedures and methods across multiple organizations(internal and external).• Ensuring systems are fully implemented and integrated with other quality managementsystems, site and global functions.• Authoring and /or revising SOPs.• Ability to provide guidance on revising validation documents and protocols.• Administer applicable electronic systems.• Assist as needed in audits and inspections.• Interacts with senior internal personnel and external partners on significant matters oftenrequiring coordination across facility locations.• Contribute to projects related to CSV improvements.• Support the Compliance team on computerized system audits to ensure compliantvendor/supplier management program and services.Mandatory Requirements• At least 6-8 years' experience in the Medical Device / FDA regulated industry with 3-5 years'experience in either Quality Assurance, Quality Management, IT Compliance or equivalent.• Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field• Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision-making skills• Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups• Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications• Good knowledge of regulatory requirements (FDA, EMEA, ICH)• Experience in international and multidisciplinary environments• Operational knowledge and experience with CS applications in a GXP environment• Experience in CSV auditing and inspections against regulatory and benchmark quality standards• Experience in working validation of ERP (SAP) and COTS application.• Ability to evaluate risks, define and execute action plans and propose innovative solutions to solve problems• Ability to work on multiple projects concurrently and prioritize resources• Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization.• Strong interpersonal and leadership skills• Proven ability to develop, present and justify positions to all levels within the company• Demonstrates attention to detail and organizational skills