|at ( view profile)|
|Date Posted||January 22, 2020|
|Address||8551 Research Way, Suite 90|
PPD Laboratories - Middleton, WI
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.
The role as a Validation Analyst at PPD, provides a unique opportunity to gain a further understanding in the fundamentals of software development life cycle, including preparation of systems for GxP use. Knowledge and use of the following skills is required:
- User requirement specifications
- Installation and Operational Qualification/Performance Qualification
- 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
- Prior experience in software validation is required for this role
If you wish to take your career to the next level, then we encourage a closer look at PPD!
Required Education & Job Experience
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
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
Work Environment Requirements
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary and/or standing for typical working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
What To Expect Next
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves. Join PPD in our relentless pursuit of excellence! If you feel your skills are a fit for this position - apply now!
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.