Senior Validation Analyst - Compliance & Project Lead

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 38,000 - 42,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental and vision)

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services is seeking a Validation Analyst III to lead validation projects across multiple sites, ensuring compliance with government and customer requirements. You will prepare validation protocols, statements and master plans, and coordinate internal and customer approvals for new and existing processes.

The role requires an Associate's Degree with 1–3 years related experience, strong math and computer skills, and the ability to communicate effectively with customers and teams.

Qualifications

• Associate's Degree in a related field. 1–3 years related experience and/or training.
• College level mathematical skills and ability to perform complex tasks.
• Full professional proficiency: speak, read, and write fluently for professional needs.
• Strong problem solving and time management abilities.

Responsibilities

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans.
• Maintains validation documentation and coordinates internal and customer approvals.
• Attends conference calls and customer meetings to communicate progress.
• Investigates deviations and documents corrective actions to complete projects.
• Reviews standards and specifications for dissemination to validation protocols.
• Ensures production documents meet internal standards and procedures.

Skills

Math skills

Computer skills

Communication

Education

Associate's Degree in related field

Tools

Office Suite

Job description

PCI Pharma Services is seeking a Validation Analyst III to lead validation projects across multiple sites, ensuring compliance with government and customer requirements. You will prepare validation protocols, statements and master plans, and coordinate internal and customer approvals for new and existing processes.

The role requires an Associate's Degree with 1–3 years related experience, strong math and computer skills, and the ability to communicate effectively with customers and teams.