Sr. Regulatory Automation Specialist

Thermo Fisher Scientific Inc. Philadelphia , PA 19107

Posted 2 months ago

Job ID :
75328BR

Location :

US - Alabama

  • Remote / Field|US - Arizona

  • Remote / Field|US - Arkansas

  • Remote / Field|US - California

  • Remote / Field|US - Colorado

  • Remote / Field|US - Connecticut

  • Remote / Field|US - Delaware

  • Remote / Field|US - Florida

  • Remote / Field|US - Georgia

  • Remote / Field|US - Idaho

  • Remote / Field|US - Illinois

  • Remote / Field|US - Indiana

  • Remote / Field|US - Iowa

  • Remote / Field|US - Kansas

  • Remote / Field|US - Kentucky

  • Remote / Field|US - Louisiana

  • Remote / Field|US - Maine

  • Remote / Field|US - Massachusetts

  • Remote / Field|US - Michigan

  • Remote / Field|US - Minnesota

  • Remote / Field|US - Mississippi

  • Remote / Field|US - Missouri

  • Remote / Field|US - Ohio

  • Remote / Field|US

  • Pennsylvania

  • Philadelphia|US

  • Pennsylvania

  • Remote / Field

:

Job Description

Job Title: Sr. Regulatory Automation Specialist

Requisition ID: 75328BR

Location: US- All states-Remote

Job Description

Essential Duties and Responsibilities

  • Responsible for identifying and driving programs for the development and implementation of qualification and validation service products globally.

  • Activities include working with the Thermo Fisher sales, factory PSE's, tech support, hardware/software development teams, and external customers to identify, define, create, and implement new qualification service opportunities.

  • The development of detailed procedures, methodologies, and work instructions for qualification services.

  • Global harmonization and standardization of procedures and processes related to qualification services.

  • Assisting in technical support of customers and the field teams with qualification and compliance related questions.

  • Assisting in the development of automation, analytic, and reporting tools for qualification.

Decision Making Authority

  • Spending related to normal acceptable T&L. No hiring or budget authority.

Specific Scope Data

  • Second level support for the field and tech support including reviewing daily support emails and calls.

  • Responsible for working with factories and product managers to define scope, timelines, and implementation of qualification products globally.

  • Pursue both cost reducing and revenue generating opportunities.

  • Keep up with industry news and identifying new technologies and methodologies for qualification services.

  • Keep up with regulatory Agency regulations and guidelines, and also with industry standards.

  • Maintain and update a library of qualification procedures, methodologies, and work instructions.

  • Create and maintain a state-of-the-art set of tools to enable the field

Minimum Education and Experience Requirements

  • 4-year degree, preferably a BS in chemistry, Biology, Physics or related.

  • Experience with a broad range of 2D/3D chromatography, mass spectrometry applications and data systems.

  • Experience with various types of laboratory equipment and instrumentation.

  • Proven project management skills.

  • Proven matrix management skills.

  • Must have had direct validation and qualification experience either in managing or maintaining laboratory equipment in a regulated environment.

  • Must have proven skills in developing, updating, reviewing procedures and documents related to local/regional agency regulations.

Knowledge, Skills, and Abilities Necessary to Perform Essential Functions

  • Position requires the individual to be capable of managing complex projects across different groups and businesses throughout the world and acting as a team leader and supervisor of others.

  • Position requires an excellent understanding of GxP and related regulations.

  • Experience in programming Chromeleon, Waters Empower and Agilent ChemStation CDS.

  • Excellent presentation, organizational and time management skills are required.

  • Proven project management skills.

  • 20% possible travel required for support, projects, field operations, or customer requests.

  • Strong experience in Microsoft OS installation, configuration, performance-turning

  • Strong knowledge of VBA, Windows Script/Powershell, Command Line

  • Knowledge of CSS/HTML5 and XML/XSL

  • Experience with Visual Studio, .NET application development

  • Demonstrate Role Model Leader Characteristics:

  • Embody the 4-I values.

  • Delight customers.

  • Communicate openly and honestly.

  • Focus on growth.

  • Champion employee development.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Rockwell Automation University (Rau) Portal Specialist

Rockwell Automation, Inc.

Posted 5 days ago

VIEW JOBS 1/11/2019 12:00:00 AM 2019-04-11T00:00 The Sales Enablement School of Technology within Rockwell Automation University (RAU) helps Rockwell Automation and distributor domain experts build the technical competency they need to support the sales process. In this role, the RAU Portal Specialist is part of a small global team responsible for all management aspects of the RAU Portal (Learning Management Center or LMC) to make the experience for students successful. On a global level this includes entering global learning objects of all types, creating global reports and dashboards that meet stakeholder requirements, and monitoring our in-box and working directly or indirectly with users to resolve their issues. This also include supporting specific regions with their day-to-day, local activities and training or supporting local specialists as needed. The RAU Portal Specialist is also responsible for working under the direction of the Learning Consultant and RAU Portal team to move the user experience forward by evaluating and implementing new features or tools such as playlists, cohorts, curated content, etc. The right candidate will bring a passion for adult learning and a deep interest in learning management systems. Attention to detail is critical. ESSENTIAL FUNCTIONS * Serve as an internal expert resource on all aspects of the RAU Portal * Manage day-to-day activities on global and regional levels * Create accounts * Create leaning objects * Create reports and dashboards using the Portal, Excel, and possibly Power BI, etc. * Monitor the inbox * Work with users to resolve issues * Assign training * Work with regions to understand needs in order to execute on them * Support or train other specialist within and outside of Sales Enablement * Enforce the Rockwell Automation way of doing things including "brand identity" of the RAU Portal * Document procedures or create other job aids for other specialist * Work with the team to execute on RAU Portal upgrades or new features within the tool EOE, M/F/DISABLE, VET #LI-CH1 #techjob Rockwell Automation, Inc. Philadelphia PA

Sr. Regulatory Automation Specialist

Thermo Fisher Scientific Inc.