Validation Analyst I: Global Impact in Biopharma

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 27,000 - 31,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage (including d

Flexible spending account

401(k)

Job summary

PCI Pharma Services in Illinois seeks a Validation Analyst I to manage validation projects for small customer accounts under close supervision. You will generate and execute validation protocols, support customer audits, and determine validation needs across projects.

This role requires adherence to cGMP, GAMP, 21 CFR Part 11, and related standards, with attention to detail and the ability to communicate progress to managers and customers.

Qualifications

• High School Diploma or GED, 1–3 years related experience or training.
• Basic Math skills required.
• Ability to perform basic computer tasks and operate common computer programs.
• Ability to participate effectively in conversations (professional proficiency).
• Ability to read standard items addressed to general readers.
• Ability to apply common sense to carry out instructions and handle problems.

Responsibilities

• Performs validation activities to ensure compliance with government and customer requirements.
• Prepares validation protocols, statements, and master validation plans for new launches and maintains existing validated processes across sites.
• Ensures validation documentation is complete and properly approved.
• Prepares change control and validation history reports for audits.
• Communicates project goals and progress to the Validation Supervisor/Manager.
• Investigates deviations and documents corrective actions to close projects.
• Acts as customer contact for validation activities and manages expectations.
• Interprets customer standards and specifications for validation protocols.
• Reviews production paperwork to ensure alignment with internal standards and procedures.
• Adheres to PCI, cGMP, GCP, GAMP, 21 CFR Part 11 and Annex 11.

Skills

Basic Math

Computer literacy

Communication

Attention to detail

Teamwork

Independent work

Education

High School Diploma or GED

Job description

PCI Pharma Services in Illinois seeks a Validation Analyst I to manage validation projects for small customer accounts under close supervision. You will generate and execute validation protocols, support customer audits, and determine validation needs across projects.

This role requires adherence to cGMP, GAMP, 21 CFR Part 11, and related standards, with attention to detail and the ability to communicate progress to managers and customers.