Validation Analyst 2

PCI Pharma Services

. Perform validation activities to assure compliance with government and customer requirements .

Posted 9/25/2026full-timeRockford • Illinois • United StatesMid-LevelSenior💰 $22 - $25 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in validation activities, ensuring compliance with government and customer requirements while effectively managing documentation and customer expectations. Proficient in interpreting standards and protocols related to quality validation and maintaining validated processes across multiple sites.

Highest-signal resume keywords

Validation Protocol PreparationCompliance with cGMP and GCPDocumentation Accuracy and ClosureCustomer Communication and ManagementChange Control Reporting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation ActivitiesDocumentation SkillsMathematical SkillsIntermediate Computer SkillsReasoning Skills

Soft Skills

Organizational SkillsCommunication SkillsProblem-Solving Skills

Certifications & Qualifications

High School Diploma or GEDDocumentation Boot Camp Course

Industry Keywords

PCICGMPGCPGAMP21CFR21CFR Part 11Annex 11

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform validation activities to assure compliance with government and customer requirements
Prepare validation protocols, validation statements, and master validation plans for new customer, product, and system launches
Maintain existing validated processes and programs at multiple sites
Organize and coordinate internal and customer approvals
Ensure validation package documentation completion, accuracy, and closure
Prepare change control and validation history reports for customer audits
Attend conference calls and customer meetings and communicate project goals and progress to the Validation Supervisor/Manager
Investigate validation deviations, document formal reports, and assure corrective action resolution
Serve as customer contact for quality validation activities and manage customer expectations
Review and interpret customer standards, procedures, and specifications for process and cleaning validation protocols
Review production jacket and issuance for compliance with internal requirements
Perform other duties as assigned

Requirements

What you’ll need

High School Diploma or GED and/or 3-5 years related experience and/or training
College Level Mathematical Skills
Intermediate Computer Skills and knowledge of various computer programs
Minimum Professional Proficiency in speaking and reading
Intermediate Reasoning skills
Ability to pass and complete a “Documentation Boot Camp” course
May require overtime and/or weekend work
Attendance to work is an essential function of this position
Knowledge of and adherence to PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements

Benefits

Comp & perks

Annual performance bonus eligibility
Paid time off
Health insurance coverage, including dental and vision
Flexible spending account
401(k) plan