Pfizer Sr. Validation Engineer CapEx in McPherson, Kansas
The Validation team is looking for a Validation Engineer familiar with equipment/facility qualification and/or capital projects to help organize and coordinate activities related to shutdown and major capital projects. This engineer will also provide strategic guidance to the team to build a sustainable planning/scheduling model moving forward. The ideal candidate will be an excellent leader and will have some level of pharmaceutical validation (or regulated industry) experience in managing staff of different disciplines to produce results in a timely manner. They will also be able to develop efficient strategies and tactics.
Reporting to the Validation Section Manager, the Validation Engineer will assure schedule adherence to major capital expense projects while ensuring 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 Validation, provide technical expertise and guidance to management and cross functions. The Validation Engineer will manage the validation of new systems and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that validation requirements are met.
Support all aspects of Validation projects.
Create, maintain, and report schedules (MS Project / MS Excel) in accordance with major capital investments with Validation Management.
Author, execute, or review 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
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
The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:
Formulate, organize and monitor inter-connected projects
Decide on suitable strategies and objectives
Coordinate cross-project activities
Lead and evaluate project managers and other staff
Apply change, risk and resource management
7+ year experience in a cGMP environment
3-5 years of direct validation experience
Strong understanding of GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations, guidance for 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
Proven experience as a Program Manager
Thorough understanding of project/program management techniques and methods
Excellent knowledge of MS Office; working knowledge of program/project management software (MS Project etc.) is a strong advantage
Outstanding leadership and organizational skills
Excellent communication skills
Excellent problem-solving ability
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.
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Last Date to Apply for Job: 11/30/2018
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.