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Senior Validation Engineer

Pfizer


Location:
Mcpherson, KS
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1614662
Pfizer
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Job Details

Job Title Senior Validation Engineer

JobID 1614662

Location: Mcpherson, KS

Description **ROLE SUMMARY**

Reporting to the Validation Section Manager, the Validation Engineer will assure that computerized systems are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards.



The Validation Engineer will be required to become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions. The Validation Engineer will manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that CSV requirements are met.



**ROLE RESPONSIBILITIES**



+ Support all aspects of Computer System Validation projects

+ Author, execute, or review CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling

+ Manage and execute decommissioning activities

+ Ability to work collaboratively with cross functions within the organization

+ Represent Validation in cross functional team meetings or projects as required

+ Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards



**QUALIFICATIONS**



+ 7+ year experience in a cGMP environment

+ 3-5 years of direct computer system validation experience

+ Strong understanding of GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures

+ Ability to work independently with limited managerial oversight

+ Bachelor's degree in Engineering, Science, or related field

+ Good written and oral communication skills



**PHYSICAL/MENTAL REQUIREMENTS**



+ Requires routine sitting, standing, walking, listening and talking

+ Acute mental and visual attention at all times

+ Handle multiple projects while managing frequent interruptions

+ Requires moderate lifting or moving up to 25 pounds (lbs)



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Requires regular onsite attendance

+ Must have the ability to work effectively under strict deadlines

+ Must be able and willing to work beyond office hours which may include weekends and holidays

+ Must be capable of supporting up to 10% travel (domestic and international)



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



+ **Last Date to apply: November 9, 2017**

+ **This job is a Hospira Exempt US Grade: 15**

+ **RELOCATION ASSISTANCE WILL BE PROVIDED**



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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