Sr. CSV Engineer

Global Force USA

Posted Under: Providence, Rhode Island jobs in Engineering; Engineering jobs in zipcode 2901
Posted On: 2020-08-03 00:00:00

Position SR. CSV Engineer Duration 6 months Position Description Our large pharmaceutical Client in Providence, RI is looking for Sr. CSV Engineer to join their team on a contract basis. Responsibilities Draft and implement Quality System documentation designed to establish good validation practices within the Organization. Work with system owners on Data Integrity and CSV assessment and provide guidance for CSV policies and procedures. Design validation approaches, draft validation protocols, perform andor coordinate all validation activities, analyze and assemble results, and draft validation reports. Draft and execute IQOQPQ protocols for software, PLC hardware, and IT systems. Provide input on user andor functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met. Assist in training and mentoring staff in the technical competencies of computer validation and in contributing to validation projects. Execute assigned duties on time and within budget pro-actively telegraph delays and other issues to relevant stakeholders. Comply with all Regulatory, Corporate, and Quality System policies Complete other projects andor assignments as required. Qualifications B.S. M.S. in Computer Science or another relevant engineering discipline. Minimum of 5+ years of experience working within regulated manufacturing. Direct experience with CSV of GxP systems is mandatory. Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements for medical devices, biotechnology, and pharmaceuticals with an emphasis on 21 CFR Part 11, including Annex 11, and Data Integrity. Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc) Familiarization with ISO 13485 and 21 CFR 820. Proficient in Microsoft Word, Excel, PowerPoint. Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously. Must demonstrate strong verbal, written, presentation, interpersonal and teamwork skills. Additional Requirements Candidates may be subject to background check and drug test.SDL2017

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