Software Validation Engineer

Website IQ Inc.

IQ Inc. provides custom software engineering services for companies with highly-engineered products. As an engaged consulting company, we are committed to the success of our clients.

We are currently looking for a Software Validation Engineer to provide technical subject matter expertise for software testing and validation of enterprise computer systems. This opportunity is to provide validation services for one of the following projects:

  • The deployment/upgrade of an Enterprise Resource Planning (ERP)
    • The deployment/upgrade of a Building Management System (BMS)

Key responsibilities in this role:

  • Document authoring activities
    • Update or create, application/software/IT validation planning documents
    • Update or create, application/software/IT risk assessment related documents
    • Update or create, application/software/IT Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents/protocols
  • Review the spectrum of computer system validation documents (plans, requirements, specifications, configuration, risk, verification, qualification) and assess compliance to FDA regulations and alignment
  • Coordinate document authoring and execution activities with both internal staff and external consultants
  • Coordinate document approval activities with Quality Assurance
  • Perform day-to-day activities within the guidance of Standard Operating Procedures (SOPs)
  • Support investigations of process deviations and application/software/IT anomalies
  • Must maintain company quality and safety standards

Requirements for this role:

  • A Bachelor’s degree a technology related field of study and/or direct applicable experience with computer systems testing/validation
  • 3 or more years of experience in directly executing computer systems validation activities in the biopharma, pharma, or medical device industries
  • Experience validating software solutions for either:
    • an ERP system
    • a BMS
  • Able to demonstrate the experience to independently carry out tasks
  • Able to demonstrate a detailed understanding of FDA cGMP quality system principles
  • Excellent interpersonal and communication skills, both written and verbal
  • Able to demonstrate an understanding of manufacturing best practices like those described in ISPE GPGs
  • Ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them

IQ Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, IQ Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

IQ Inc. expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of IQ Inc.’s employees to perform their job duties may result in discipline up to and including discharge.