Validation Specialist

Position: Validation Specialist 3
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 ownership of high-risk project(s) under limited to no supervision. Responsible for generation and execution of validation protocols, assistance in audits, determination of validation needs, and training of Analysts. This job has no supervisory responsibilities.
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* 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, 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.
* 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.
* 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, 21

CFR, 21

CFR Part 11 and Annex 11  policies, procedures, rules, and requirements.
* Will be required to complete and pass “Documentation Boot Camp” and “Train the Trainer” courses.
* This position may require overtime and/or weekend work.
* Attendance to work is an essential function of this position.
* Performs other duties as assigned.“High Risk Projects” are generally defined as projects/customer accounts that have the following.
* Business needs of customer/project may require considerable time commitments.
* High level of uncertainty in managing customer expectations.
* Have a validation approach with significantly more or more complex requirements in addition to the Validation Master Plan.
* May or may not have established criteria, which may be subject to interpretation.

After basic training, this position will be required to specialize in 1 or more Validation areas of focus:
* Process/Cleaning Validations
* HVAC/Utility Validations
* Computer Validations
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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.
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* Required:

*** Associate's Degree in a related field and/or 1-3 years related experience and/or training.
* College-level mathematical skills
* Advanced Computer

Skills:

Ability to perform the most complex computer tasks and has knowledge of most 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…