Title: *Senior Validation Engineer*
Reports to: Manager, Validation Services Overview: The Senior validation engineer is responsible for delivering all validation documentation and coordinating all testing, requirements and design deliverables, Validation and testing SOPs in support of COTS or in house system development activities. Perform validation of computerized systems & software by implementation of the strategy, documentation, qualification, validation and testing of all systems with respect to good software engineering practice and specific regulatory requirements such as 21 CFR Part 11 Maintain all documentation pertaining to qualification and validation Generate software and/or computerized systems validation plans Develop/review software and/or computerized systems requirements and specifications Follow-up and resolve reviewers' comments, deviations, and technical issues Coordinate the proper approval of plans, requirements, and protocols Perform validation protocol execution Review protocols for completeness, cGxP compliance and data acceptability Prepare validation summary and final reports Provide support to the Quality department in any regulatory inspections or audits of software systems developers or vendors Support change control, configuration management systems, Gap Analysis and re-validation events, development of Corrective action/Preventative Action Plans Document deviations, system failures, and corrective action Participate in corrective action investigations Review change requests to evaluate validation impact Plan and schedule validation projects Coordinate validation execution between all involved departments Coach, develop and mentor junior testing and validation staff to ensure documentation and process consistency Qualification and validation of new and proposed systems including: o Medical Imaging and workflow systems o Business Process Management system o Document Control system o Clinical Data Management system Qualifications BA/BS degree or equivalent in Engineering, Life Science, Computer Science, or technical discipline 5-7 years of validation experience or related experience and/or training. The ability to interface and communicate with multiple groups Thorough knowledge of *cGCPs, GAMP, validation principles, and change control* *PC proficiency with MS Office, Outlook and Project* *5-7 years of experience in pharmaceutical, biotech or related industries is preferred* *Workflow/Business Process systems and medical imaging systems validation experienc*e is preferred The ability to generate* validation protocols (IQ, OQ , PQ ) *for a variety of systems Mark Syscom Technologies, Inc. Phone: 703-565-2313 Fax: 703-991-5645 [email protected] --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "direct reqs" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/direct-reqs?hl=en -~----------~----~----~----~------~----~------~--~---
