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. Facilitates the validation process and implementation of system upgrades, including guiding,
testing, supporting the introduction and ongoing support of software systems.

Essential Functions and Other Job Information:
• Participates as a validation representative at project team meetings and
completes assigned action items. Provides direction for future releases to
software systems; reviews and approves/rejects change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints.
• 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 all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.
• Ensures test scripts challenge the functional requirements and adequately
demonstrate that the application meets the expectations of the business
customer.
• 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 sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits.
• Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
• Participates in the identification of user requirements and system design and
assists in the preparation and review of system documentation such as
requirements and design specifications for software systems and/or
instrumentation.

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 2+ years).
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, and strong oral and written communication skills and ability to teach others

• Needs to have either Software testing experience (GMP software testing, laboratory instrument applications) OR Enterprise applications (IT software testing utilizing IQOQPQ or UAT format)

• Nice to haves: -Prior GMP experience

-GMP Documentation experience

-IT project management experience

-Familiar with 21 CFR Part 11 and FDA/EMA CSV

• 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

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

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