Pfizer Sr. Validation Engineer CapEx in McPherson, Kansas

ROLE SUMMARY

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

ROLE RESPONSIBILITIES

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

QUALIFICATIONS

  • 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.

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 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.