Validation Analyst II - Protocols & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Rockford (IL); Hybrid; 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 is seeking a Validation Analyst II to join our team in Rockford, IL. You will manage validation projects for intermediate customer accounts under moderate supervision, and you will prepare validation protocols, statements, and master validation plans for new launches and existing processes across multiple sites.

You will coordinate internal and customer approvals, attend conference calls and meetings, investigate deviations, document corrective actions, and effectively communicate project

Qualifications

• High school diploma or GED with 3–5 years related experience.
• College level mathematical skills.
• Intermediate computer skills and ability to perform more complex tasks.
• Minimum professional proficiency for speaking and reading in professional contexts.
• Intermediate reasoning; apply common sense to instructions and problems.

Responsibilities

• Performs validation activities to ensure compliance with government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new customer/product/system launches and maintains existing validated processes across multiple sites.
• Ensures validation package documentation completion, accuracy, and closure including internal and customer approvals.
• Prepares change control and validation history reports for customer audits.
• Attends conference calls and communicates project goals and progress to Validation Supervisor/Manager.
• Investigates validation deviations, documents in formal reports, and ensures corrective action resolution.

Skills

Math skills

Computer skills

Professional proficiency

Reasoning ability

Time management

Communication

Education

High School Diploma or GED

Job description

PCI is seeking a Validation Analyst II to join our team in Rockford, IL. You will manage validation projects for intermediate customer accounts under moderate supervision, and you will prepare validation protocols, statements, and master validation plans for new launches and existing processes across multiple sites.

You will coordinate internal and customer approvals, attend conference calls and meetings, investigate deviations, document corrective actions, and effectively communicate project