IT Validation Lead (Tester)2

Diverse Lynx

Job Title: IT Validation Lead (Tester)2

Location: Jacksonville, FL

Duration: Fulltime

Job Details.

Relevant Experience

(in Yrs)

06-10 years Must Have Technical/Functional Skills

Required Skills:

Previous experience working with software validation and compliance activities in a GXP regulated medical device / biopharmaceutical environment; in one or more of these areas:

o IT Enterprise software

Ability to work within a global team and handle multiple priorities effectively.

Knowledge of Systems Development Lifecycle (SDLC) as it applies to computer software for FDA regulated industry.

Thorough knowledge of US 21 CFR Part 820 and 21 CFR Part 11 regulations, ISO13485, EU Annex 11, FDA and international Data Integrity Guidelines, and FDA s General Principles of Software Validation.

Expertise with Agile and Waterfall software development & testing methodologies.

Excellent understanding and application of principles, concepts and practices of Risk Management, Validation, Root Cause Analysis/Failure Investigation.

Excellent written and verbal communication, interpersonal, conflictmanagement, and organization skills.

Highly Desirable Skills:

Experience performing computerized systems periodic validation reviews in GXP regulated industry.

Knowledge of Corrective and Preventive Actions (CAPAs) in FDA regulated industry.

Relatable knowledge of FMEA and risk management

Experience Required

Minimum 6 years work experience in Software Validation within the Medical Device and/or Biopharmaceutical industries

Roles & Responsibilities

The Software Quality Engineering (SQE) Consultant will be responsible for providing software quality and validation support for Customer s computer integrated management systems and related interfaces.

Perform software periodic reviews for GXP software.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.


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