Associate Validation Analyst II - GMP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is a hybrid role based at our GMP Lab in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  

Must be legally authorized to work in the United States without sponsorship. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

This is a hybrid position requiring the ability to work onsite in Middleton, WI multiple times per week as needed.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Purpose:
Provides basic 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 and implementation of system upgrades, including guiding, testing, and supporting the introduction, as well as ongoing support of software systems.

Responsibilities:

• Participates as a member of project teams, contributing to direction on future enhancements to the system, reviewing change requests and ensuring effective communication and accuracy in testing.

• Provides 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 change controls associated with validated systems per SOP and ensures test scripts challenge the functional requirements and adequately demonstrate the application meets the expectations of the business customer. Reviews PQ and change control documentation with leadership per SOP.

• Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably. 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.

Education and 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 1 to 2 years).

• Prior GMP experience preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Client-focused approach with strong interpersonal skills

• Strong oral and written communication skills • Strong attention to details and-problem solving skills

• Ability to adapt and adjust to changing priorities

• Solid competency with Microsoft Office Suite (Word, Excel, and PowerPoint) Positive attitude, enthusiasm toward work, and the ability to work well with others

Working Environment

Thermo Fi