Business Systems and Validation Analyst II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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.

Summarized Purpose: 

This role is part of a small global team focused on validating the lab instrumentation in accordance with the European Medicines Agency (EMA) guidelines.  This role will work on system development lifecycle deliverables, work on project timelines, participate in client and regulatory inspections, and work closely with various departments and vendors to ensure effective communication, accuracy, and support throughout the project lifecycle.

Requirements

Preform system risk assessments

Create system validation test cases and testing summary reports

Create system diagrams

Qualifications:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

• Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, and experience.

• Familiar with EMA and other regulatory guidelines

• Good MS Office skills.

• Ability to estimate level of effort for small to medium-sized projects.

• Strong problem-solving and analytical skills.

• Strong planning and organizational skills.

• Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC).

• Ability to attain, maintain, and apply a working knowledge of applicable SOPs/WPDs, and process maps.

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.

• For Labs-based staff travel up to 60-80% of time, domestically with extended overnight stays. Light/occasional travel for corporate-based staff.

• For Labs-based staff, exposure to biological fluids with potential exposure to infectious organisms.

• For Labs-based staff, personal protective equipment is required such as protective eyewear, garments and gloves.

•  Exposure to fluctuating and/or extreme temperatures on rare occasions.