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CSV Lead

Job in South Naperville Area, Will County, Illinois, 60564, USA
Listing for: Hyper Recruitment Solutions Ltd
Full Time position
Listed on 2026-06-20
Job specializations:
  • Engineering
    Validation Engineer, Quality Engineering, Regulatory Compliance Specialist, Pharma Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

ROLE OVERVIEW

An exciting opportunity for a CSV Stream Lead (Siemens PCS7) to join a leading pharmaceutical company during a major expansion project. This pivotal role is based within the life sciences industry, offering the chance to oversee critical Computer System Validation (CSV) activities for a new manufacturing facility. As the CSV Stream Lead, you will be instrumental in managing the CSV workstream, ensuring all validation activities are executed efficiently and in compliance with regulatory standards.

This role provides an excellent platform to leverage your industry expertise and contribute to the successful delivery of a state‑of‑the‑art manufacturing environment.

KEY DUTIES AND RESPONSIBILITIES
  • Lead the CSV workstream and manage execution resources through project completion.
  • Participate in design reviews alongside Automation, Engineering, and CQV teams.
  • Oversee validation strategy and testing execution across PCS7, MES, integrated PLC systems, FMS, and EMS platforms.
  • Ensure all CSV deliverables are completed on time and in compliance with project and regulatory requirements.
  • Coordinate validation activities, ensuring standards are met and documentation is thorough.
ROLE REQUIREMENTS
  • A Degree or higher level in a scientific or engineering discipline.
  • Proven extensive industry experience in Computer System Validation within GMP-regulated pharmaceutical or biotech environments.
  • A working knowledge and practical experience with Siemens PCS7, including hands‑on expertise.
WHAT’S IN IT FOR YOU?

This role offers the chance to work on a high‑profile project within the life sciences industry, supporting groundbreaking developments in pharmaceutical manufacturing. You will be part of a dynamic team, with opportunities for professional growth, exposure to cutting‑edge technology, and the chance to make a real impact on a significant expansion initiative.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.

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