Validation Analyst

Position: Validation Analyst 3-1
## Validation Analyst 3-1

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Rockford, IL, USA:
Full time:
Posted Today:
JR119618

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
** Summary of Objective:
** The Validation Analyst III is responsible for overall validation project management of large customer accounts under minimal supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs. This job has no supervisory responsibilities.
*
* Essential Duties and Responsibilities:

** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
* 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 as needed.
* 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, 21

CFR, 21

CFR 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.
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* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
*
* Required:

*** Associate's Degree in a related field and/or 1-3 years related experience and/or training.
* College Level Mathematical Skills
* Intermediate Computer

Skills:

Ability to perform more complex computer tasks and has knowledge of various computer programs.
* Full Professional Proficiency:
Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
* High Reasoning:
Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
** Preferred
* ** Ability to effectively present information to various people as the job requires.
* Ability to follow instructions and respond to management direction.
* Ability to identify and resolve problems in a timely manner.
* Ability to display…