Global Validation Analyst — Life Sciences Compliance

Pci Pharma Services; Rockford (IL); On-site; USD 37,000 - 43,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services is seeking a Validation Analyst III to manage validation projects for large customer accounts across multiple sites. You will generate and execute validation protocols, coordinate audits, and determine validation needs with minimal supervision.

The role emphasizes cross-site collaboration, adherence to cGMP and regulatory standards, and timely documentation of validation history. Overtime and weekend work may be required; a competitive benefits package is offered.

Qualifications

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.
• College Level Mathematical Skills
• Full Professional Proficiency: speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: ability to solve practical problems with limited standardization

Responsibilities

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new customer / product / system project launch and maintaining existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals.
• Ensures validation package documentation completion, accuracy, and closure including organizing and coordinating internal and customer approvals.
• Prepares change control and validation history report for customer audits.
• Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor / Manager.
• Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project.
• Customer contact for quality validations activities and manage customer expectations.
• Reviews and interprets customer standards, procedures and specifications for dissemination relative to process and cleaning validation protocols.
• Reviews production jacket and issuance to ensure that documents meet internal requirements for standards and procedures.
• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
• Required to pass and complete a “Documentation Boot Camp” course.
• This position may require overtime and/or weekend work.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned.

Skills

Mathematical skills

Computer literacy

Professional English

Problem solving

Education

Associate's Degree in a related field

Tools

GxP Knowledge

Documentation Systems

Job description

PCI Pharma Services is seeking a Validation Analyst III to manage validation projects for large customer accounts across multiple sites. You will generate and execute validation protocols, coordinate audits, and determine validation needs with minimal supervision.

The role emphasizes cross-site collaboration, adherence to cGMP and regulatory standards, and timely documentation of validation history. Overtime and weekend work may be required; a competitive benefits package is offered.