Computerized System Validation (CSV) Engineer

Job description

Job Title: Computerized Systems Validation Engineer (CSV) Engineer

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Our Team/ Overview

Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improve lives.

Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways.

Within our Sanofi Manufacturing & Supply Ambition, we’re redefining our strategy, culture, and processes to make a tangible impact worldwide.

In this role, you'll join the Automation & Manufacturing Systems department at our Swiftwater site, supporting directly the manufacturing system automation computer system validation.

As a Computerized Systems Validation Engineer, you are responsible to ensure that all automation computerized systems used in manufacturing processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations.

Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Systems (e.g., environmental monitoring system [EMS], batch record management systems [MES], Data Historian, Process Control Systems (e.g., distributed control system [DCS], programmable logic controller [PLC]), Computerized Process Equipment, and other integrated systems.

You will support the establishment and maintenance of automation computerized systems validation program.

You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives.

We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Ready to get started?

Main Responsibilities:

About You

Education

Basic Qualifications

Preferred Qualifications

Technical & Behavioral Skills

Related KPIs and metrics:
Timely validation and documentation updates.

Percentage of applied and effective security patches.
Backup procedure success rate and reliability.
Reduction in OT system downtime incidents.
Compliance adherence in validation processes.

Disclaimer

The above information was designed to indicate the general nature and level of work performed by employees with this job description.

It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities.

This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

Why Choose Us?

Sanofi Inc.

and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue , discover

Better is out there.

Better medications, better outcomes, better science.

But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !

Sanofi Inc.

and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience.

Employees may be eligible to participate in Company employee benefit programs.

Additional benefits information can be found through the .

Required Skill Profession

Engineers