Global Validation Analyst II — Compliance & Impact

PCI Pharma Services; Winnebago Court (IL); On-site; USD 31,000 - 34,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services in the United States seeks a Validation Analyst II to oversee validation project management for intermediate customer accounts under moderate supervision. You will generate and execute validation protocols, assist in customer audits, and determine customer validation needs.

The role emphasizes coordination across multiple sites, handling change controls, and ensuring compliance with 21 CFR Part 11 and cGMP policies. Weekend overtime may be required.

Qualifications

• High School Diploma or GED with 3–5 years related experience.
• Proficiency with mathematical concepts and data analysis.
• Experience with multiple computer programs and intermediate computer skills.
• Ability to participate effectively in conversations and read standard items.

Responsibilities

• Manage validation activities to meet government and customer requirements.
• Prepare validation protocols, statements, and master plans across sites.
• Coordinate internal and customer approvals and change controls.
• Prepare validation history reports for customer audits.
• Attend meetings and report progress to the Validation Supervisor/Manager.
• Investigate deviations and implement corrective actions.
• Interface with customers on quality validation activities and expectations.
• Review standards and specifications for validation protocols.

Skills

Mathematical skills

Computer skills

Professional communication

Reasoning

Education

High School Diploma or GED

College level mathematical skills

Job description

PCI Pharma Services in the United States seeks a Validation Analyst II to oversee validation project management for intermediate customer accounts under moderate supervision. You will generate and execute validation protocols, assist in customer audits, and determine customer validation needs.

The role emphasizes coordination across multiple sites, handling change controls, and ensuring compliance with 21 CFR Part 11 and cGMP policies. Weekend overtime may be required.