CSV Engineer

Job Title: 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:

• The Computer System Validation Engineer will be responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
• Design and execute validation protocols and testing.
• Create and manage validation documentation.
• Troubleshoot validation issues, conduct risk assessments and support audit.
• Record and analyze deviations and downtime for root cause identification.
• Provide technical expertise in CS validation lifecycle for OT systems.
• Ensure OT systems comply with regulatory and industry standards.
• Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.
• Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.
• Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.
• Author CSV plans and procedures.
• Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.
• Ensure continual improvement of CSV program by performing periodic review of the program.
• Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.
• Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.
• Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.
• Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.

About You
Education and experience:

• Bachelor’s or Master’s degree in Science, Engineering, or related Life Sciences or Technology fields.
• A minimum 4-7 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
• Key technical competencies and soft skills:
• Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.
• Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.
• Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.
• Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
• Good communication skills to present validation strategies to the site management and other functions.
• Familiar with Digital 4.0 concepts and control systems.
• Able to work independently with little supervision.
• Experience with ensuring Data Integrity in computerized systems.
• Expertise in OT system validation processes and lifecycle.
• Knowledge of security patch management for control systems.
• Experience in backup protocol development and validation.
• Ability to analyze deviations and implement corrective actions.
• Understanding of regulatory and industry standards for OT systems.
• Strong problem-solving and documentation skills.
• Knowledge in DCS, PLC, SCADA, BMS, EMS and HMI systems
• Understanding of ISA-95, ISA-88 standards.
• Problem-solving and project management 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?