Validation Project Lead II for Life-Saving Therapies

PCI Pharma Services; Rockford (IL); On-site; USD 30,000 - 33,000; Full time

Benefits offered by this job

Paid time off

Health insurance (including dental & 0

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services is seeking a Validation Analyst II to oversee validation project management for intermediate customer accounts under moderate supervision. Responsibilities include generating and executing validation protocols, supporting customer audits, and determining validation needs across multiple sites.

The role requires knowledge of PCI, cGMP, GCP, 21CFR, and related regulations; candidates should have a high school diploma or GED with 3-5 years of related experience, strong math,

Qualifications

• Requires High School Diploma or GED
• College level mathematical skills
• Ability to perform intermediate computer tasks
• Professional proficiency to participate in conversations
• Intermediate reasoning to carry out instructions

Responsibilities

• Manage validation activities to ensure compliance with government and customer requirements.
• Prepare validation protocols, validation statements, and master validation plans for new launches and existing processes.
• Coordinate internal and customer approvals and maintain validation documentation.
• Prepare change controls and validation history reports for audits.
• Attend calls/meetings and communicate progress to the Validation Supervisor/Manager.
• Investigate deviations and document corrective actions to complete projects.
• Serve as customer contact for quality validation activities and manage expectations.
• Review standards and specifications for dissemination to validation protocols.
• Review production jacket/documents to meet internal standards.
• Overtime and/or weekend work may be required.

Skills

High School Diploma or GED

College Level Mathematical Skills

Intermediate Computer Skills

Minimum Professional Proficiency

Intermediate Reasoning

Education

High School Diploma or GED

Job description

PCI Pharma Services is seeking a Validation Analyst II to oversee validation project management for intermediate customer accounts under moderate supervision. Responsibilities include generating and executing validation protocols, supporting customer audits, and determining validation needs across multiple sites.

The role requires knowledge of PCI, cGMP, GCP, 21CFR, and related regulations; candidates should have a high school diploma or GED with 3-5 years of related experience, strong math,