Assoc IT Validation Analyst

PPD Middleton , WI 53562

Posted 2 months ago

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

Rapid growth of our cGMP Laboratory has created new opportunities for computer system validation professionals in Middleton, WI. Our validation team plays an integral role in our mission by ensuring new laboratory systems are tested, deployed, and supported in a manner consistent with internal SOPs and external regulations. The role requires you to devise test strategies and drive the execution of testing to provide evidence of requirements coverage and traceability.

No prior validation experience is required for this role and it provides a unique opportunity to gain an understanding in the fundamentals of software development life cycle, including preparation of systems for GxP use. Having exposure to any of the following skills would be advantageous.

  • User requirement specifications

  • Installation and Operational Qualification/Performance Qualification

  • GAMP

  • 21 CFR Part 11 and/or Annex 11

  • Data integrity

  • Investigating, documenting and communicating software defects.

  • Maintaining broad awareness of efforts within groups to assure technical quality excellence, accurate execution, and appropriate use of resources.

  • Developing new and improving existing Standard Operating Procedures

If you wish to take your career to the next level, then we encourage a closer look at PPD!

Requirements:

  • 2-4 yr degree or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities

  • Attention to detail and problem-solving skills

  • Client focused approach with strong interpersonal skills

  • Strong oral and written communication 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

  • 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 draft and review and critique documentation including Requirements, Functional Design, System Design, and Test Plans

  • Ability to assess the cause of test failures

Minimum Required 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

Fundamental training, knowledge and experience with systems or software validation processes Required Knowledge, Skills and Abilities:

Client focused approach with strong interpersonal skills

Strong oral and written communication skills

Strong attention to detail

Ability to adapt and adjust to changing priorities

Competent with MS Word, MS Excel, MS PowerPoint

Working Conditions: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international.

Physical Demands: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

  • LI-OD1

Additional Information

  • Requisition ID: 156043
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Assoc IT Validation Analyst

PPD