Sr. Regulatory Automation Specialist

Thermo Fisher Scientific Inc. Philadelphia , PA 19107

Posted 2 months ago

Job ID :

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US - Alabama

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  • 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

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.

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