IT Computer Validation Specialist

IT Computer Validation SpecialistAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location/Division Specific InformationREMOTEHow will you make an impact?The Computer Systems Validation (CSV) Lead will design and run compliance activities for the assigned GxP regulated computerized systems throughout each system's lifecycle. This responsibility includes ensuring compliance with regulatory requirements, company Computer Systems Validation(CSV) and system lifecycle procedures and data integrity requirements.What will you do?The CSV Lead will contribute to OneMaximo growth and expansion by:Reviewing current processes, procedures and policies and recommend improvements to ensure compliance with regulatory requirements, including leading or participating in cross functional process improvement initiatives.

Being an resolutions focused and a key IT contact point for quality related issues.

Development and approval of validation documentation, including system lifecycle documentation, test scripts, validation plans and summary reports

Through a risk-based approach, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems

Lead or perform periodic reviews of computerized systems

Lead or support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems is integrated into Quality Management System

Initial point of contact for client audits and regulatory inspections. Lead IT responses to inquiries arising from audits or inspections

Provide support in other quality system related activities including quality exceptions and change control

How will you get here?Education / ExperienceBA/BS required in Life Sciences, IT related discipline or equivalent experience with 6-7+ years of appropriate work experience preferred. Less experience 5+ required with a Master’s degree

Minimally 6+ years’ experience with CSV in a life sciences, biotech or pharmaceutical company required, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity

Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment

Knowledge, Skills, AbilitiesExcellent organizational skills and attention to detail and accuracy

Experience supporting health authority inspections a plus

Experience successfully coordinating and navigating complex issues with internal and external stakeholders

Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities

Ability to positively empower and influence team members without line-management authority

Excellent communication, analytical, and organizational skills, using modern technology platforms

Highly collaborative standout colleague who cultivates open communication and facilitates mutual understanding and collaboration between all stakeholders

Ability to draft and implement procedures, work instructions, and appropriate procedures for CSV

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 global team of 90,000 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.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.