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Validation Analyst- Software

  • Location: Middleton, Wisconsin, 53562
  • Job Type:Contract

Posted 4 days ago

Our client, a well respected CRO with global reach, is in search of 4 Instrument Validation Analysts for 6 month contracts, temp to perm possible to increase software validation capacity to support lab growth.

Duration: 6 month contract, possible contract to hire
Location: Middleton, WI (must be local to the area upon start, and some onsite work is required)
Shift: 1st Shift
Experience in a GMP/Regulated lab, computer software validation experience required
Instrument system qualification experience and awareness of 21 CFR Part 11 preferred.

Performs validation of computer-based laboratory instrument systems and software in a GMP environment. Coordinates and executes the IQ/OQ/PQ activities for assigned systems. Facilitates the validation process as well as implementation of system upgrades, including duties of guiding, testing, supporting the introduction, and ongoing support of software systems. Participates as a member of the Project teams where needed and help provide direction on future enhancements to the system.

Education and Experience:
Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities
2 years experience in the validation of computer-based laboratory instrument systems in a GMP regulated environment

Knowledge, Skills and Abilities:
Client focused approach with strong interpersonal skills.
Strong oral and written communication skills and ability to teach others.
Strong attention to detail and problem solving skills.
Competent with MS Word, MS Excel, MS PowerPoint, MS Project.
Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others.
Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple
assignments with challenging/conflicting deadlines.
Good understanding of software development life cycle (SDLC).
Proven ability to learn new computer software with minimum of instruction.
Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced.
Ability to attain, maintain and apply a working knowledge of applicable SOPs/WPDs