Medical Device Software Validation Engineer - Consultant

Propharma Group, Inc. Irvine , CA 92606

Posted 3 weeks ago

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

This Computer Systems Validation Consultant position is responsible for independently managing Computer System Validation related projects and providing consulting and contract services to clients. It will provide basic support to computer system validation activities focusing primarily on verification test execution and limited technical writing. Some co-authorship of industry blogs and white papers on technical topics of current interest is expected.

Essential Functions Include:

  • Obtain specific assignments from ProPharma Group or client Project Manager.

  • Ensure individual activities are clearly communicated and documented to Project Manager.

  • Execute basic qualification protocols (IQ/OQ/PQ), document deviations, and develop traceability matrices.

  • Review assigned protocols prior to execution.

  • Perform technical writing and communicate clearly on all technical, business, and professional interpersonal levels of the organization.

  • Apply Computer System Validation experience as it relates to GxP regulated business processes.

  • Attend and contribute to scheduled Practice meetings.

  • Participate in company programs such as Project Management, Quality, Social Responsibility, Wellness, Safety and Training.

  • Create annual personal goals and development plan with administrative manager.

  • Assist with interviews of ProPharma Group candidates.

  • Extensive travel required.

  • Other duties as assigned.

Qualified candidates must have:

  • B.S./B.A. in Engineering, Science, Information Technology or related field.

  • Three years of relevant work experience may be substituted in lieu of education.

  • Minimum 5-year experience in the field of Computer System Validation.

  • Minimum 5-year experience in related Pharmaceutical or Healthcare Industries.

  • Develop and execute software Validation protocols for processes, facilities, software and equipment within the medical device facility.

  • Experience in the validation of at least one computer system category: automation control, laboratory systems, quality workflow, ERP, clinical data.

  • Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.

  • General business math skills.

  • Working knowledge of Microsoft Word, Microsoft Excel, and other word processing programs as may be required by the position (PowerPoint, Access and Microsoft Project may be required) including but not limited to Visio.

  • Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.

  • Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.

  • Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).

  • Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.

  • All candidates must be legally eligible to work in the United States.

  • We are an equal opportunity employer. M/F/D/V

  • ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

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Medical Device Software Validation Engineer - Consultant

Propharma Group, Inc.