Validation Engineer II

Employer
Pfizer
Location
McPherson, Kansas
Posted
Oct 06, 2021
Ref
4807812
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

Reporting to the Validation Section Manager, the Validation Engineer II will assure that equipment, computer systems such as vision systems, and/or manufacturing processes are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards

The Validation Engineer II is expected to become a subject matter expert (SME) in Validation, provide technical expertise and guidance to management and cross functions. The Validation Engineer will assist the validation of new systems/products/process, as well as changes to existing systems/products/processes, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that requirements are met. The Validation Engineer II is expected to work independently with minimal guidance of a Validation Section Manager or Sr. Validation Engineer.

ROLE RESPONSIBILITIES

The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:

  • Support the development of new processes or troubleshoot existing ones. 
  • Author, execute, or review Validation documents such as:Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling.
  • Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Coordinates and communicates all testing with affected functional groups and evaluates test results.
  • Oversee/Assist other Validation Engineers and/or Technicians and/or contractors with their assigned projects.
  • Work independently with minimal guidance of a Validation Section Manager or Sr. Validation Engineer.
  • Supports activities during regulatory audits under the direction of a Validation Section Manager or Sr. Validation Engineer.
  • Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
  • Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
  • Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.

QUALIFICATIONS

Basic Qualifications:

  • 2-4 years’ experience in a current Good Manufacturing Practice (cGMP) environment.
  • Ability to work independently with limited managerial oversight
  • Bachelor’s degree in Engineering, Science, or related  
  • Good written and oral communication skills

Preferred Qualifications:

  • 1-2 years of direct validation experience preferred
  • 1-2 years of prior primary packaging and or secondary packaging experience
  • Working Knowledge of cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, Data Integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), industry good practices for Installation Qualification/Operational Qualification/Performance Qualification and Standard Operating Procedures.

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 and ability to work remotely when necessary
  • 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)

Last date to apply for job: October 31, 2021

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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.

Quality Assurance and Control

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