Senior Facilities & CSV Validation Lead

PCI Pharma Services; Rockford (IL); On-site; USD 108,960 - 122,580; Full time

Job summary

PCI Pharma Services is seeking a Facilities and Software Validations Manager in Rockford, IL. The role focuses on coordinating validation for facilities, utilities, and computer systems, ensuring cGMP compliance and continual improvement of validation policies.

You will lead the Validation team, develop the Validation Master Plan, and ensure rigorous testing and documentation across multiple sites, aligning with FDA, GAMP 5, and ISO standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science or related technical discipline.
• 6–8 years in facilities, utilities, and computer system validation in a regulated industry.
• Strong knowledge of CSV, GAMP 5, and FDA regulations (21 CFR Parts 820, 210/211, 11).
• Proven ability to lead validation teams and produce clear validation documentation.

Responsibilities

• Oversee Validation staff and project delivery.
• Develop and maintain Validation Master Plan, policies, and procedures.
• Plan, execute, and oversee validation of facilities, utilities, and computer systems.
• Ensure data integrity principles (ALCOA+) across computerized systems.
• Lead CSV activities in line with GAMP 5, FDA, and ISO requirements.
• Coordinate validation activities with other departments and customers.

Skills

Leadership

Advanced computer skills

Regulatory knowledge

Written communication

Education

Bachelor's degree in Engineering, Life Sciences or Computer Science

Job description

PCI Pharma Services is seeking a Facilities and Software Validations Manager in Rockford, IL. The role focuses on coordinating validation for facilities, utilities, and computer systems, ensuring cGMP compliance and continual improvement of validation policies.

You will lead the Validation team, develop the Validation Master Plan, and ensure rigorous testing and documentation across multiple sites, aligning with FDA, GAMP 5, and ISO standards.