Associate Validation Engineer

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Oct 08, 2020
Ref
4794142
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

As an Associate Validation Engineer you will be responsible for validating/qualifying the systems used to manufacture and/or clean drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

ROLE RESPONSIBILITIES

The Associate Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:
  • 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.
  • Executes process and/or cleaning validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
  • Participates in presentation of results to Regulatory Agency when necessary.
  • Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
  • Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
  • Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).


BASIC QUALIFICATIONS
  • BS/BA degree in science, engineering, manufacturing technology or closely related field is required
  • Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
  • Strong conflict resolution skills
  • Must be able to interact with varying levels within the company
  • Must be able to work multiple shifts as needed to meet deadlines


PREFERRED QUALIFICATIONS
  • Relevant experience or Internship / Co-Op experience in pharmaceutical, engineering, or manufacturing industries highly preferred
  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices is preferred
  • Some knowledge and experience with cleaning and/or process validation of pharmaceutical processes, as related to sterile products and medical devices preferred

PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
  • May involve standing for long periods of time.
  • Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Primary work schedule is Day shift, Monday - Friday but evenings and weekends will be required, as needed. Some travel,


Other Job Details:
  • Last Date to Apply for Job: 10/22/2020
  • Eligible for Employee Referral Bonus


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