FDA Medical Validation Engineer - Remote

Job Title: FDA Medical Validation Engineer

Remote

Contract

Position Description

The validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s

Health policies and procedures, and industry standards. This individual will assist the company to develop and implement operating procedures associated with individual projects designed to support quality system related validation protocols in a way that embraces 21CFR820, 21CFR Part 11 and ISO 13485

requirements.

Primary Responsibilities

• Reviews site software/process applications and provide computerized system validation, consultation, training, and evaluation.
• Lead and manage software and process validation projects by reviewing, assisting with the preparation of and, where appropriate, executing validation protocols, test plans and reports.
• Creates regulation awareness and develops inherent validation requirements and protocols within their site that align with Client s Health policies and procedures.
• Liaise with colleagues and site management associated with Manufacturing, IT/IS Systems, Software and Hardware design groups to create best validation practices within the business.
• Coordinate, track and report on validation tasks.

Key/Critical Competencies

• Strong Knowledge of US FDA and international validation requirements and associated regulations including 21 CFR Part 820, 21 CFR Part 11, ISO 13485, good automation manufacturing practices (GAMP), software life cycle development methodology, and Capability Maturity Model (CMM)
• Ability to interface with developers and lead validation projects on one or more operating systems including but not limited to Lotus Notes, VAX/VMS, Visual Basic, Oracle, SAP, Sequel, MasterControl, and other similar enterprise-based systems.
• Knowledge of network operating systems, medical device-based protocols and regulations impacting validation of medical information systems (e.g., HIPAA).
• Working knowledge of validation practices to include Software, Products, Process, Facilities, Equipment, and Utilities, networks, servers and operating systems.
• Demonstrates excellent written, oral and interpersonal skills with personnel at all levels
• Exhibits a high degree of integrity, initiative and motivation.

Education and Experience

• A BS degree or higher in Engineering, Computer Science or other commensurate technical degree with 3+ years of experience in computer validation in an FDA regulated industry.
• Experience in medical device systems software and/or process validation.
• FDA audit experience (preferred)