Thermo Fisher Scientific
Associate Validation Analyst II
Thermo Fisher Scientific, Middleton, Wisconsin, United States, 53562
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office
Job Description
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.
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• 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
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Knowledge, Skills, Abilities
Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
Strong attention to details and problem-solving skills
Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction
Positive attitude, enthusiasm toward work, and the ability to work well with others
Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines
Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)
Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced
Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps
Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures
Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office
Job Description
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.
Es
s
e
n
t
ial F
u
n
c
t
i
o
ns a
n
d O
t
h
e
r
J
o
b Info
r
ma
t
i
o
n
:
• 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
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Knowledge, Skills, Abilities
Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
Strong attention to details and problem-solving skills
Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction
Positive attitude, enthusiasm toward work, and the ability to work well with others
Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines
Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)
Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced
Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps
Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures
Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.