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Validation Analyst I (Computer System Validation Analyst)

Responsible for overall validation project ownership of limited risk project(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Performs validation activities to ensure compliance to government and customer requirements.

Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch and maintains existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals, as needed. Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.

Prepares change control and validation history report for audits.

Attends conference calls and meetings.

Communicates effectively project goals and progress to Validation Supervisor / Manager.

Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project.

Primary contact for quality validation activities and managing expectations. Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols.

Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.

Required to complete and pass a “Documentation Boot Camp” course within 6 months.

This position may require overtime and/or weekend work.

Attendance to work is an essential function of this position.

Performs other duties as assigned. “Limited Risk Projects” are generally defined as projects/customer accounts that have the following.

Business needs of customer/project require standard time commitments.

Low level of uncertainty in managing customer expectations.

Standard validation approach as documented in the Validation Plan. Established criteria that are subject to minimal interpretation.

QUALIFICATIONS:

Required:

High School Diploma or GED and/or 1-3 years related experience and/or training.

Basic Mathematical Skills

Basic Computer Skills: Ability to perform basic computer tasks and can operate common computer programs.

Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read multiple types of standard items addressed to general readers.

Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.

For candidates in Illinois: This position's base hourly hiring range is $19.95-$22.60 plus an annual performance bonus eligibility. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k.