Associate Validation Analyst II

Pharmaceutical Product Development (PPD)

WI-Middleton-Middleton WI Research Way


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

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 an Associate Validation Analyst II 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:

Provides business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete Performance Qualification (PQ) validation activities. Facilitates the validation process as well as implementation of system upgrades, including 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.

• Serves as Validation Support for new releases, and modifications to applications, throughout the Software Development Life Cycle. Prepares Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases. Reviews and approves all change controls associated with the validated systems per SOP. Reviews PQ and change control documentation with the IT Project Manager per SOP. Meets with project teams on a regular basis to ensure effective communication and accuracy in testing. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions correctly. Creates, updates, and manages data within the testing environment, sufficient to accurately test software functionality.

• Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided.

• Participates as member of Project Teams for the purpose of providing direction for future releases to software systems and reviewing and approving/rejecting change requests.

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

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

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 an Associate Validation Analyst II 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:

Provides business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete Performance Qualification (PQ) validation activities. Facilitates the validation process as well as implementation of system upgrades, including 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.

• Serves as Validation Support for new releases, and modifications to applications, throughout the Software Development Life Cycle. Prepares Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases. Reviews and approves all change controls associated with the validated systems per SOP. Reviews PQ and change control documentation with the IT Project Manager per SOP. Meets with project teams on a regular basis to ensure effective communication and accuracy in testing. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions correctly. Creates, updates, and manages data within the testing environment, sufficient to accurately test software functionality.

• Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided.

• Participates as member of Project Teams for the purpose of providing direction for future releases to software systems and reviewing and approving/rejecting change requests.

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

PPDLABSRequired Education & Job Experience

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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.

Required Education & Job Experience

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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.


2020-08-07 00:00:00


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