Validation Analyst

2 weeks ago

Middleton, United States Thermo Fisher Scientific Full time

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.

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.

**A day in the Life**:

- 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.
- Reviews and approves all change controls associated with validated systems per SOP. 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, 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.

**Keys to Success**:
**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).

**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, 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 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

**Physical Requirements / Work Environment**:
Thermo Fisher Scientific 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 w

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