CSV Engineer

Responsibilities:

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.
• Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Author and develop SOP and VMP for computer system validation for manufacturing equipment.
• Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
• Provide input on user and/or 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.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies

Qualifications:

• B.S. / M.S. in engineering or another relevant discipline.
• Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
• Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.),
• Understanding of c.G.x.P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
• Experience with 21 CFR Part 11 and Data Integrity.
• Working knowledge GAMP 4 and GAMP 5 categorization and their respective deliverables for Computer Systems Validation lifecycle.
• 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 communication, interpersonal and teamwork skills.
• A strong understanding of technical writing and presentation skills is required.

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